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Ume University Medical Dissertations

New Series No 1405 ISSN 0346-6612 ISBN 978-91-7459-153-8


Obstetrics and Gynecology
Department of Clinical Sciences
Ume University, SE-901 87 Ume, Sweden

Vaginal prolapse Clinical


outcomes and patients perspectives
A study using quantitative and qualitative methods

Mojgan Pakbaz
2011

Department of Clinical Sciences, Obstetrics and Gynecology


Ume University, SE-901 87 Ume, Sweden

Responsible publisher under swedish law: the Dean of the Medical Faculty
This work is protected by the Swedish Copyright Legislation (Act 1960:729)
ISBN: 978-91-7459-153-8
ISSN: 0346-6612
Omslag: Pr Andersson
Elektronisk version tillgnglig p http://umu.diva-portal.org/
Printed by: Print och Media, Ume University
Ume, Sweden 2011
2

To my daughter

Contents
Abstract ..................................................................................................................................................................................................................................

iii

Svensk Sammanfattning ....................................................................................................................................................................................

List of abbreviations .............................................................................................................................................................................................

vii

List of publications .................................................................................................................................................................................................

ix

Introduction ......................................................................................................................................................................................................................

Background ........................................................................................................................................................................................................................

Epidemiology of pelvic organ prolapse ......................................................................................................................................

Etiology and risk factors for pelvic organ prolapse ......................................................................................................

Pelvic organ prolapse quantification system ........................................................................................................................

Symptoms related to pelvic organ prolapse .........................................................................................................................

Local symptoms ........................................................................................................................................................................................

Urinary symptoms ...................................................................................................................................................................................

Bowel symptoms ......................................................................................................................................................................................

Sexual symptoms .....................................................................................................................................................................................

.....................................................................................................................................................................................................................

Expectancy ......................................................................................................................................................................................................

Treatment

Pessary .................................................................................................................................................................................................................

Surgery .................................................................................................................................................................................................................

Surgery for POP using local anaesthesia ..................................................................................................................................

Outcome measures ............................................................................................................................................................................................

Anatomical outcome versus subjective outcome ...............................................................................................

Patients knowledge of POP and healthcare-seeking behaviour ...................................................................

Physical and psychological well-being related to POP .............................................................................................

10

Quantitative study design ...........................................................................................................................................................................

10

Qualitative research in urogynaecology .....................................................................................................................................

11

Qualitative research an overview ......................................................................................................................................

11

Qualitative and quantitative research ...............................................................................................................................

12

Qualitative content analysis .........................................................................................................................................................

13

Trustworthiness in qualitative research ...........................................................................................................................

13

The healthcare system in Sweden .....................................................................................................................................................

13

Healthcare quality registers in Sweden .......................................................................................................................................

14

History ...................................................................................................................................................................................................................

14

Aim of the quality registers ..........................................................................................................................................................

14

14

The Swedish National Quality Register for Gynaecological Surgery (Gynop-register) ....

Aims .................................................................................................................................................................................................................................................

19

Subjects and methods .........................................................................................................................................................................................

21

Paper I ................................................................................................................................................................................................................................

21

Non-response analysis (paper I) ......................................................................................................................................................... 22

Paper II .............................................................................................................................................................................................................................. 22

Paper III ............................................................................................................................................................................................................................ 23

My pre-understanding ........................................................................................................................................................................ 24

Paper IV ........................................................................................................................................................................................................................... 24

Statistical methods ............................................................................................................................................................................................. 25

Paper I and IV ............................................................................................................................................................................................... 25

Paper II ................................................................................................................................................................................................................. 25
Ethics .................................................................................................................................................................................................................................. 26

Results .......................................................................................................................................................................................................................................

27

Paper I ................................................................................................................................................................................................................................

27

Paper II .............................................................................................................................................................................................................................. 28

Paper III ............................................................................................................................................................................................................................ 29

Paper IV ........................................................................................................................................................................................................................... 30

General discussion ...................................................................................................................................................................................................

35

Effects of POP surgery on symptoms .......................................................................................................................................... 35

Complications after vaginal hysterectomy .............................................................................................................................. 36

Vaginal hysterectomy for treatment of uterine descent ..........................................................................................

37

Impact of anaesthesia on prolapse surgery ...........................................................................................................................

37

Qualitative research as a complementary tool .................................................................................................................. 38

Healthcare-seeking behaviour ............................................................................................................................................................... 38

Description and causes of POP reported by subjects ............................................................................................... 39

Sources of information on specific conditions ................................................................................................................... 39

Methodological considerations ............................................................................................................................................................ 40

Conclusion ...........................................................................................................................................................................................................................

47

Clinical implications ...............................................................................................................................................................................................

49

Future research ..........................................................................................................................................................................................................

51

Acknowledgements .................................................................................................................................................................................................

53

References ............................................................................................................................................................................................................................

55

Appendix 1 ...............................................................................................................................................................................................................................

67

Paper IIV
ii

Abstract
Background: Pelvic organ prolapse (POP) is a relatively common condition. In Sweden, the
overall estimated prevalence of POP in the female population is 31% and the prevalence of
symptomatic prolapse is 815%. The prevalence of POP increases with age. The lifetime risk of
undergoing pelvic floor surgery is estimated to 11%.
The aim of this thesis was to investigate outcomes of vaginal hysterectomy for treatment of
prolapse; to study outcomes of cystocele repair surgery and patient satisfaction related to different
anaesthesia methods; to explore womens experiences of vaginal prolapse; and to investigate what
is known regarding POP prior to surgery and healthcare-seeking behaviour.
Methods: In the Swedish National Quality Register for Gynaecological Surgery (Gynop-register),
941 women were identified who underwent vaginal hysterectomy for prolapse from 1997 to 2005
and 1,364 women were identified who underwent cystocele repair surgery from 2006 to 2009.
In-depth interviews were performed with 14 women with vaginal prolapse. Interview data were
analyzed with a qualitative content analysis. To investigate womens knowledge about POP and
healthcare-seeking behaviour, a questionnaire was developed, validated and distributed to women
with planned surgery for POP. Women undergoing hysterectomy or incontinence surgery were
used as reference groups.
Results: Severe complications after vaginal hysterectomy occurred in 3% of cases. Sexual activity was
improved after vaginal hysterectomy, the number of women reported to have intercourse increased
by 20% (p = 0.006). Subjective symptoms of urinary incontinence and overactive bladder were
resolved in 50% of the women. De novo stress incontinence was reported by 11% of the women.
Use of local anaesthesia (LA) in reconstruction of cystocele showed advantage over other forms
of anaesthesia. Length of hospital stay, duration of use of postoperative pain-killing drugs, and
time to return to daily activity were shorter among women who underwent surgery with LA compared to other forms of anaesthesia. Patient satisfaction was not related to methods of anaesthesia.
In an interview study, the process from recognition of the symptoms to seeking healthcare was
highlighted. Two categories, obstacles and facilitators to seeking health care, were identified.
One of the obstacles was lack of information about POP in the public domain. The main facilitators were feeling sexually unattractive and impaired physical ability due to POP.
Some findings from the interview study were further explored in the questionnaire study.
One out of five women with vaginal prolapse did not know that the symptoms were related to
prolapse before consulting their physician. Over 30% of the women in the incontinence group
were embarrassed to talk about incontinence, and they were unaware that it could be treated. The
most frequent description of vaginal prolapse was vaginal bulging. Women in the prolapse group
had significantly less access to information through brochures and public media than women in
the incontinence group (p < 0.001).

iii

Conclusion: Short-term follow-up after vaginal hysterectomy showed that sexual activity and
urinary symptoms had improved. Cystocele surgery using LA showed no disadvantage compared
to surgery using other anaesthesia methods. POP surgery can therefore be performed safely
with LA. Information regarding prolapse should be easily accessible to improve the possibility
for women of gaining knowledge and thereby overcoming obstacles to seeking medical advice.
Healthcare professionals have a significant role to play in informing women about symptoms
and available treatment options.

iv

Svensk Sammanfattning
Bakgrund: Framfall r ett vanligt frekommande tillstnd bland kvinnor. I Sverige uppskattas
prevalensen av framfall i den kvinnliga befolkningen vara 31 % och prevalensen av symtomatiskt
framfall 8-15%. Frekomsten av framfall kar med stigande lder. Risken fr en kvinna att
genomg bckenbottenkirurgi under sin livstid berknas vara 11 %.
Syftet med denna avhandling var att studera resultat efter vaginal hysterektomi fr behandling av framfall, att studera utfallet av cystoceleoperation relaterad till olika anestesiformer och
att underska patientens tillfredsstllelse i frhllande till olika anestesier. Vidare var syftet att
utforska kvinnornas upplevelse av framfall och att underska deras knnedom om framfall och
faktorer som pverkar att kvinnor sker sjukvrd fr sitt tillstnd.
Metoder: I det Nationella kvalitetsregistret inom gynekologisk kirurgi (Gynop-registret), identifierades 941 kvinnor som har genomgtt vaginal hysterektomi fr framfall frn 1997 till 2005 och
1364 kvinnor som har genomgtt cystocele operation frn 2006 till 2009. Fjorton kvinnor med
vaginal prolaps djupintervjuades och data analyserade med hjlp av en kvalitativ innehllsanalys.
I syfte att underska kvinnornas knnedom om framfall och faktorer som pverkar deras kontakt
med sjukvrden utformades en enkt som sedan validerades. Enkten distribuerades till kvinnor
med en planerad framfallsoperation samt till kvinnor med en planerad urininkontinensoperation
eller hysterektomi, dr de bda senare grupperna anvndes som referensgrupper.
Resultat: Efter vaginal hysterektomi tillsttte en svr komplikation hos 3 % av kvinnorna. Kvinnornas sexuella aktivitet har kat efter vaginal hysterektomi. Antalet kvinnor som rapporterade
att de hade samliv kade med 20 % (p = 0,006) jmfrt med preoperativt. Subjektivt upplevda
symtom av urininkontinens och veraktiv blsa frsvann hos 50 % av kvinnorna. Nytillkommen
stressinkontinens rapporterades av 11 % .
Anvndning av lokalanestesi i cystoceleoperation visade frdelar jmfrt med andra anestesiformer. Kvinnor som opererades i lokalanestesi hade i genomsnitt kortare vrdtid, behvde ta
smrtstillande medicin kortare tid och tergick snabbare till daglig aktivitet jmfrt med kvinnor
som opererades i andra anestesiformer. Patientens tillfredsstllelse var inte relaterad till anvndning av viss typ av anestesi vid operation.
Vid den intervju som genomfrdes med kvinnor avseende deras upplevelse av framfall, belystes
den process som brjade med igenknnande av symtom och som ledde fram till att kvinnorna
skte sjukvrd. Tv kategorier, hmmande respektive frmjande faktorer fr att ska sjukvrd
identifierades. En hmmande faktor fr att ska sjukvrd som beskrevs av kvinnorna var brist p
information om framfall. Knsla av att vara sexuell oattraktiv och av nedsatt fysisk frmga, till
fljd av framfall, var dremot faktorer som frmjade kvinnorna att ska sjukvrd.
Vissa fynd som vi fann i intervjustudien har vidare underskts i en uppfljande enktstudie.
En av fem kvinnor med framfall visste inte att symtomen berodde p framfall. ver 30 % av
kvinnor med urininkontinens skmdes att prata om sitt tillstnd och var omedveten om att tillv

stndet kunde behandlas. Den mest frekventa beskrivningen av framfall, bland de tre underskta
grupperna, var vaginal utbuktning. Kvinnor med framfall hade mindre tillgng till information
via broschyrer och media jmfrt med kvinnor med urininkontinens (p < 0,001).
Konklusion: Korttidsuppfljning efter vaginal hysterektomi visade att sexuell aktivitet och urogenitalsymtom frbttrades. Cystoceleoperation i lokalanestesi visade inte p ngra nackdelar jmfrt
med operation i andra anestesiformer. Framfallsoperation kan drfr med frdel genomfras i
lokalanestesi. Information avseende framfall borde vara lttillgnglig s att kvinnor kan skaffa sig
kunskap om tillstndet och vervinna hinder fr att ska vrd. Sjukvrdspersonal har en viktig
roll fr att informera patienterna om relaterade symtom och tillgngliga behandlingsalternativ.

vi

List of abbreviations
ADL:

Activity of daily life

ASA:

The American Society of Anaesthesiologists Physical Status Classification System

BMI:

Body mass index

CA:

Content analysis

GA:

General anaesthesia

Gynop-register: The Swedish National Quality Register for Gynaecological Surgery


HRT:

Hormone replacement therapy

ICS:

International Continence Society

LA:

Local anaesthesia

NIH:

National Institutes of Health

NBHW:

National Board of Health and Welfare

PFD:

Pelvic floor disorder

POP:

Pelvic organ prolapse

POP-Q:

Pelvic Organ Prolapse Quantification System

QOL:

Quality of life

RA:

Regional anaesthesia

RCT:

Randomized controlled trial

SALAR:

The Swedish Association of Local Authorities and Regions

SFOG:

The Swedish Society of Obstetrics and Gynaecology

SUI:

Stress urinary incontinence

UI:

Urinary incontinence

VAS:

Visual analogue scale

vii

viii

List of publications
This thesis is based on the following papers, which will be referred to by their Roman numerals:
I Pakbaz M, Mogren I, Lfgren M. Outcomes of vaginal hysterectomy for uterovaginal
prolapse: a population-based, retrospective, cross-sectional study of patient perceptions
of results including sexual activity, urinary symptoms, and provided care. BMC Womens
Health 2009, 9:9
II Pakbaz M, Mogren I, Lfgren M. Outcomes of cystocele repair surgery in relation to
different anesthesia methods. Acta Obstet Gynecol Scand 2010; 89: 876881
III Pakbaz M, Persson M, Lfgren M, Mogren I. A hidden disorder until the pieces fall into
place a qualitative study of vaginal prolapse. BMC Womens Health 2010, 10:18
IV Pakbaz M, Rolfsman E, Mogren I, Lfgren M. Vaginal prolapse - Perceptions and healthcare-seeking behaviour among women prior to gynecological surgery. In manuscript
Paper II is printed with the permission of Copyright Clearance Center.

ix

Introduction
Vaginal prolapse is characterised by protrusion of the vaginal wall downward to the introitus.
The term is synonymous with pelvic organ prolapse (POP), and the term prolapse used in this
thesis refers to vaginal prolapse. One of the treatment options for uterovaginal prolapse is vaginal
hysterectomy (1). Little is known about patient-perceived results of vaginal hysterectomy with
prolapse as the indication. In the last decades, the use of local anaesthesia (LA) has been expanding
in POP surgery. LA has been used to correct more advanced forms of vaginal prolapse (2-3). These
studies have been performed by gynaecologists with great experience of prolapse surgery using LA.
However, the degree of safety of performing prolapse surgery under LA in the routine healthcare
setting is unknown. Furthermore, how patients perceive such care is also unknown. There have
been few studies focusing on the effect of POP surgery from the point of view of the patient.
Most studies regarding POP have been related to surgical anatomical outcomes (4). Studies
of womens experiences and perceptions of vaginal prolapse are sparse. Thus, an interview study
and a questionnaire study were conducted with women who had had vaginal prolapse.
The overall aim of the thesis was to investigate perception of vaginal prolapse, clinical outcomes,
and the results of prolapse surgery from the patients point of view.

Background
The International Continence Society (ICS) defined POP as descent of one or more vaginal
segments: the anterior, the posterior, or the apex of the vagina (cervix/uterus) or vault after
hysterectomy (5). This definition may include up to half of the female population (6-7). Pelvic
floor disorder (PFD) includes urinary incontinence (UI), POP, and fecal incontinence. POP
causes symptoms of the lower genital, urinary, and gastrointestinal tracts and negatively affects
the quality of life of a patient, but rarely results in severe morbidity or mortality (8-9).
Prolapse surgery accounts for 20% of the patients on the waiting list for gynaecological surgery in the UK (10), and in Sweden approximately 7,000 surgeries due to POP are performed
every year. The goals of surgery for POP should be relief of symptoms. Most studies evaluating
outcomes of POP surgery have focused exclusively on anatomical success without considering
the most important issue for the patient, which is symptom relief. There have been very few
published studies on patient-perceived outcome after surgery for POP.
EPIDEMIOLOGY OF PELVIC ORGAN PROLAPSE
Most epidemiological studies on POP have been from selected materials such as clinical populations or surgical registers (11-13). Incidence and prevalence estimates based only on the rates of
surgical procedures probably underestimate the magnitude of POP.
Loss of vaginal support is observed in 4376% of women examined during routine gynaecological care, and 36% has descent of vaginal structures beyond the hymenal remnants (6,
14). In a cross-sectional study, prevalence of symptomatic POP was reported to be 3% (15). In
Sweden, the prevalence of symptomatic POP has been estimated to range between 8.3% and
15% (16-17).
The lifetime risk of surgery because of POP by the age of 80 years has been estimated to
be about 11% (13). An estimated 1330% of patients will be in need of repeat surgery due to
recurrence (13, 18).
ETIOLOGY AND RISK FACTORS FOR PELVIC ORGAN PROLAPSE
POP is multifactorial in its etiology (9, 19). The most prominent risk factor for development
of POP is vaginal delivery (12, 20-23). Pelvic viscera are supported by the levator ani muscle
and connective tissue attachments of the pelvic organs, the so-called endopelvic fascia (24).
Defects in the levator ani muscle have been noted on MRI in 20% of primiparous women
after a vaginal delivery, suggesting that it may contribute to development of POP (25-27).
Furthermore, neuromuscular dysfunction that occurs during vaginal birth contributes to pelvic
floor dysfunction (28-29). Other obstetric factors that have been associated with an increased
risk of POP include forceps delivery and macrosomic infant (14, 30-31). Pregnancy itself has
been suggested to be a risk factor for prolapse (32)

. Most cases of symptomatic prolapse appear a long time after vaginal delivery, and most women who have been pregnant do not have
symptomatic prolapse (33).
3

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Advancing age and increasing body mass index (BMI) have also been associated with POP (6,
13-14, 20-23, 30, 34-35). However, the possible correlation between prolapse and increased BMI
is not confirmed in another study (31).
Furthermore, genetic factors (36-38) and ethnic differences (21, 39) have been suggested to
play a part in the development of prolapse. African-American women show the lowest risk of
developing prolapse compared to white women (21, 39), while Hispanic women have the highest
risk of developing prolapse (14, 21). In addition, connective tissue disorders (40-41) and changes
in the collagen metabolism (42) have been shown to be associated with an increased risk of POP.
The presence of oestrogen and progesterone receptors in the pelvic floor muscle and lower
urinary tract have been demonstrated (43). Menopause is cited as a risk factor for POP, due to
the loss of oestrogen production (44-45). However, there is limited evidence from randomised
controlled trials concerning the use of oestrogen for prevention and management of POP (46).
Heavy lifting (36, 47-48) and repetitive straining in patients with chronic constipation (4950) have been proposed to be risk factors for POP. Arya et al. showed that individuals with POP
of stage II or greater had an increased risk of developing constipation (50). However, findings
in some studies have shown a weak association between constipation and prolapse, and stage of
prolapse does not correlate with bowel function (51-53). Likewise, an increasing prevalence of
constipation with advancing age has been shown previously (54).
Previous hysterectomy has been identified as a risk factor for POP (12, 22, 55-57); however,
development of symptomatic prolapse might occur many years after the hysterectomy (12-13, 22,
30, 58). The risk of prolapse following hysterectomy is 5.5 times greater in women undergoing
hysterectomy for prolapse than in women undergoing hysterectomy for other reasons (12). In
addition, the risk of undergoing POP surgery is 4 times greater in women with a vaginal hysterectomy (not for prolapse) than in non-hysterectomised women (56).
PELVIC ORGAN PROLAPSE QUANTIFICATION SYSTEM
In 1996, the International Continence Society (ICS) Standardisation Committee introduced a
standard system of terminology for description of POP (5). The system is called the Pelvic Organ
Prolapse Quantification System (POP-Q). The descent of the anterior, posterior wall and the
apex of the vagina (cervix/vaginal cuff ) are measured using the hymen as the point of reference
while the patient is straining.
Five stages of vaginal prolapse are defined in the classification of POP-Q.
Stage 0: No prolapse.
Stage I: The most distal portion of the prolapse is > 1 cm above the level of the hymen.
Stage II: The most distal portion of the prolapse is 1 cm proximal or distal to the hymen.
Stage III: The most distal portion of the prolapse is > 1 cm below the hymen.
Stage IV: Complete eversion of the total length of the lower genital tract is demonstrated.
In a multi-centre observational study of 1,004 women aged 1883 years, at routine gynaecological
examination, 24% had stage 0 prolapse, 38% had stage I, 35% had stage II, and 2% had stage
III prolapse according to POP-Q (14).

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SYMPTOMS RELATED TO PELVIC ORGAN PROLAPSE


Symptoms related to pelvic organ prolapse are listed in Table 1.
Women with POP may have either one symptom, such as vaginal bulging or pressure, or a
combination of symptoms from the bladder, the bowel, and/or the pelvic floor. The complex
relationship between prolapse and symptoms has been investigated in several studies, and in
general there are weak to moderate correlations between the degree of prolapse and the presence
of specific symptoms related to the urinary tract, to the bowel, and to sexual function (6, 59-61).
Table 1. Symptoms associated with pelvic organ prolapse (Modified from Barber 2005).
Symptoms
Local symptoms
Sensation of vaginal bulging
Vaginal pressure
Sensation of heaviness in pelvis or vagina
Urinary symptoms
Incontinence
Urgency
Frequency
Feeling of incomplete emptying
Manual reduction of prolapse to start voiding

Differential diagnosis
Vaginal cyst
Rectal prolapse
Inguinal or femoral hernia
Pelvic tumour
Urethral sphincter deficiency
Detrusor overactivity
Urinary tract infection

Bowel Symptoms
Incontinence of flatus or liquid/solid stool
Feeling of incomplete emptying
Digital evacuation
Splinting vagina or perineum to complete defecation

Anal sphincter disruption


Rectal prolapse
Irritable bowel syndrome
Pelvic floor neuropathy

Sexual symptoms
Dyspareunia
Decreased arousal

Vaginal atrophy
Other sexual disorder

Local symptoms

The only symptom specific for prolapse acknowledged consistently by patients with severe prolapse is the presence of a vaginal bulge that is either visible or perceptible (6, 59-61). In studies
with self-reported symptoms of POP, expressions such as sensation of something falling out of
the vagina have been used to describe vaginal prolapse
(23, 62-64)
. Studies suggest that symptomatic prolapse of stage II or higher are more associated with local symptoms (35, 60-61, 64-65).
Several studies have indicated that pelvic floor symptoms increase when the edge of the prolapse extends beyond the hymen (35, 66-67). However, observation of pelvic organ support in
women examined at a regular gynaecological examination revealed that only 2% had prolapse
that reached the introitus (6). Furthermore, a recently published study has indicated that pelvic
floor-related symptoms do not predict the anatomical location in women with mild to moderate prolapse (68), and symptoms such as vaginal heaviness and pressure appear to have a weak
relationship with POP (6, 59, 61).

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Urinary symptoms

Symptoms from the lower urinary tract can coexist with prolapse (55,

69-71)
. In a review article, the prevalence of stress urinary incontinence (SUI) in women with POP was reported to be
1383%
(72)
. Defects in the support of the anterior vaginal wall affect bladder and urethral function, with formation of cystocele and bladder neck hypermobility, contributing to SUI (73-74).
Women with a mild degree of prolapse may have SUI (9, 71). In contrast, women in whom the
prolapse extends beyond the hymen are less likely to report SUI due to mechanical obstruction of
the urethra (6, 9, 59-61). These women are more likely to complain of obstructed voiding, of the
need to reduce prolapse manually in order to urinate, and of urinary retention (9, 60). Women
with advanced prolapse and no symptoms of urinary incontinence (UI) may reveal a UI during
urodynamic investigation if their prolapse is reduced, so-called occult SUI (75). These women
are at greater risk of developing SUI after surgery (76).
Post-void residual urine (> 100ml) is observed in 30% of women with stage III or stage IV
prolapse (77). Urodynamic investigation of women with varying degrees of anterior vaginal
prolapse has shown that women with grade III or IV cystocele have voiding dysfunction to a
greater extent than women with a mild degree of prolapse
(78)
. Symptoms of voiding dysfunction, particularly the need to splint to urinate, have been found to resolve postoperatively in the
majority of patients who report the symptoms preoperatively (79).
The prevalence of urge/mixed UI in women with POP has ranged between 21%73% in
different studies (72). The relationship between the degree of prolapse and overactive bladder
symptoms such as urgency and urge incontinence has been inconsistent in different studies
(61, 78). Women with an advanced stage of cystocele are more likely to have overactive bladder
symptoms and a urodynamic diagnosis of detrusor overactivity (52%) than women with a mild
degree of cystocele (20%) (78). However, another study has demonstrated that advanced stages
of prolapse are associated with a decline in the symptoms of urgency and urge incontinence (61).
Bowel symptoms

Bowel symptoms such as incomplete rectal emptying, the need for splinting and digiting in order
to start or complete defecation, straining, fecal incontinence, and urgency are frequently symptoms
reported by women with rectocele (49, 67, 80). However, there is a weak correlation between the
severity of prolapse and bowel dysfunction (51, 59-61). Digitation to defecate is reported in 36%
of women who have posterior wall prolapse and 25% of women with anterior and posterior wall
prolapse of stage II or more (72). Some studies have indicated that most women with rectocele
do not have bowel symptoms and that some women without prolapse may use digital pressure
to accomplish bowel evacuation (49, 51, 81).
The prevalence of fecal incontinence in women with POP ranges between 7%31% (72,
82-83). Vaginal prolapse and fecal incontinence share common risk factors, i.e. neuropathic and
muscular injury to the pelvic floor during childbirth, and can also be an effect of ageing (33).
Sexual symptoms
The prevalence of sexual symptoms in women with POP ( stage II) ranges between 9%57%
(72)
. Women with POP are more likely to cite pelvic floor symptoms as a reason for sexual inactivity than women with other conditions (84-85). However, studies have suggested that in general,
6

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women with POP have the same rate of sexual activity as women of the same age without POP
(86). In women with POP, the most common reason for being sexually inactive is argued to be
the result of ageing, of menopause, or to having no sexual desire (86-87).
The prevalence of sexual dysfunction in middle-aged women has been estimated to be about
817% (88). Interestingly, there is a high prevalence of pelvic floor dysfunction in this age group,
but its effect on sexuality was not noted in that particular study. Observations based on casecontrol studies have demonstrated a lower frequency of intercourse in women with symptoms
of UI/POP than in the controls (89-90). Furthermore, reduced sexual activity because of fear of
urine leakage during intercourse was found to be more common in the group with UI/POP than
in the controls (89). Handa et al. found that women with UI have more sexual problems than
women with POP (90). The relationship between pelvic floor symptoms and sexual function was
investigated in a case-control study, which demonstrated that women with symptomatic prolapse
(stage IIIIV) have reduced arousal and infrequent orgasm (91). Another interesting finding of
this study was that age and menopause did not appear to be significant confounders.
In a review article, the prevalence of dyspareunia in women with POP of stage II was reported
to range between 8%69% (72). Most of the variation in the prevalence is due to inconsistent
definitions and different outcome measures to assess dyspareunia (92). Dyspareunia has a multifactorial background and is a common symptom in older women; it is often due to vaginal dryness
as a result of low oestrogen levels (93-95).
TREATMENT
The indication for treatment of POP is based on patients symptoms. According to published
studies, when the leading edge of vaginal prolapse is beyond the hymenal remnants (some stage
II and all stage III); women may have increased symptoms of prolapse (6, 35). The aim of the
intervention should be improvement in subjective symptoms with minimal complications. Treatment options are expectancy, pessary use, or surgery. The choice of treatment options depends
on the physicians and the patients preferences.
Expectancy

Expectancy can be suitable in women who have a mild degree of prolapse and who report little
or no bother from the disorder. Pelvic floor exercise is usually recommended during the expectancy period and is commonly used in the treatment of urinary and fecal incontinence (96-97).
However, its roll in prevention and treatment of POP is uncertain (98). Results from one study
have indicated that daily pelvic floor muscle training can slow progression of anterior prolapse
in elderly women (99).
Pessary

The use of pessaries for POP is limited to women with symptoms of vaginal prolapse but who
decline surgical intervention, who are awaiting surgery, who wish to have more children, or
when surgery is not appropriate because of poor health. Most data on pessary use are limited to
case reports of complications, and no randomised trials of pessary use in women with POP were
identified in a Cochrane review (100).

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Surgery

Women whose symptoms are not adequately relieved by conservative management or women
who decline use of a pessary are candidates for surgery. POP can be managed surgically with
either a reconstructive or an obliterative technique.
Obliterative surgery includes total colpocleisis or LeForts partial colpocleisis. These procedures
are suitable for elderly, medically compromised women who are not sexually active. The aim of
reconstructive surgery for POP is to restore the prolapsed vagina while preserving vaginal sexual
function. The most preferred route for POP reconstructive surgery is vaginal, and as many as
8090% of operations are performed in this way (11, 101). Prolapse can arise from an isolated
segment of the vagina but several vaginal segments are often affected. As a result, reconstructive
surgery involves a combination of repairs of anterior, apical, and/or posterior vaginal wall.
Recurrence of POP after surgery is not uncommon; an anatomical recurrence up to 40%
has been observed at examination 5 years after surgery (102). Most reoperations due to relapse
occur at the same anatomical site (60%), and a smaller proportion of reoperations (32%) occur
at sites different to that of the previous surgery (18). Anterior wall repair is the most frequently
performed operation, and a high rate of anatomical recurrence is well-known (19, 79, 103). Most
studies have investigated reoperation rates based on anatomical recurrence without reporting
POP-related symptoms (18).
The most frequently performed POP reconstructive surgery in Scandinavian countries has
been the Manchester repair, which includes anterior and posterior colporrhaphy, cervix amputation, and perineorrhaphy (104). Several authors have reported the occurrence of dyspareunia
and vaginal strictures after extensive prolapse surgery (105-106). Thus, avoidance of prophylactic
repair of rectocele in asymptomatic women has been recommended (107). Crafoord et al. have
shown the occurrence of a shift in treatment tradition to more selective compartmental repairs
in Sweden (108).
Hysterectomy due to prolapse is usually performed by a vaginal approach (109). A recently
published Swedish study has shown a five-fold increased rate of vaginal hysterectomy with prolapse
as the indication (110). Simple vaginal hysterectomy is not effective in correcting the uterovaginal
prolapse
(111)
. Transvaginal apical suspension procedures include high uterosacral ligament suspension, iliococcygeus ligament fixation, McCall culdoplasty, and sacrospinous ligament suspension
(112-113). Two frequent approaches for apical fixation include abdominal sacrocolpopexy, which
suspend the upper vagina from the sacral promontory with synthetic material, and transvaginal
sacrospinosus ligament suspension, which put up the upper vagina to the ligament between the
ischial spine and the sacrum (4). Comparison of these two procedures has revealed that abdominal
sacrocolpopexy is associated with a lower degree of recurrent prolapse but greater morbidity and a
longer surgery time than vaginal sacrospinosus ligament fixation (4, 103, 114-115).
Because of the high anatomical recurrence rate in prolapse surgery, different kinds of biological
and synthetic material, such as mesh, have been introduced in the last decade (4). Side effects
associated with the use of mesh in the vagina include mesh erosion and dyspareunia (116-117).
Thus, the use of mesh is recommended for selected patients only (116).

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SURGERY FOR POP USING LOCAL ANAESTHESIA


The use of LA in prolapse surgery has been expanded in the last decade (2-3). However, there
have been few studies comparing outcomes of POP surgery using different forms of anaesthesia
and with long-term data on recurrence rate.
Over 800 consecutive gynaecological surgeries including endometrial resection, termination of
pregnancy, and hysteroscopies have been performed under LA without sedation in an outpatient
setting and are highly accepted by patients (118). Many such procedures are now commonly
performed under LA. The first series of prolapse surgeries under LA in a group of elderly women
(mean age 80 years) who were poor candidates for general anaesthesia showed the success of the
procedures (119). Other studies have shown the feasibility of pelvic reconstructive surgery under
LA (2, 120-123). A randomised trial comparing LA with sedation and general anaesthesia for
the vaginal correction of POP showed that the total hospital costs were lower for the group that
received local anaesthetic (124).
OUTCOME MEASURES
Outcome measures are tools used to determine the efficacy and side effects of a treatment. POP
is a multi-dimensional phenomenon, and success of treatment is often difficult to define (125).
However, most studies have focused on anatomical success without considering symptoms and the
quality of life (QOL) of the patient. In most studies in this field, outcomes of surgery have been
assessed using questionnaires evaluating the efficacy of treatment regarding symptoms, sexuality,
and QOL (126). In Scandinavia, condition-specific questionnaires for POP and UI have been
developed for identification of these disorders and for assessment of the subjective cure (64, 127).
Anatomical outcome versus subjective outcome

Due to the lack of standardised definitions for success of treatment following POP surgery, the
National Institutes of Health (NIH) Workshop on Standardisation of Terminology for Pelvic
Floor Disorders recommended the following definitions for treatment success: optimal anatomical outcome (POP-Q stage 0) and satisfactory anatomical outcome (POP-Q stage I) (128).
However, 75% of women presenting for annual gynaecological examination without symptoms
of POP will not meet the definition of optimal anatomical outcome and almost 40% will not
meet the definition of satisfactory anatomical outcome (14).
Publications with the lowest success rates have defined success as more stringent anatomical
outcomes while studies with the highest success rates have generally used subjective outcomes
such as satisfaction and relief of symptoms of POP (115, 129).
Definitions of vaginal prolapse that include the absence of vaginal bulge symptoms have the
strongest relationships with patients own assessment of improvement and treatment success, and
are more clinically relevant (125).
PATIENTS KNOWLEDGE OF POP AND HEALTHCARE-SEEKING
BEHAVIOUR
Several studies have investigated womens attitudes to UI and healthcare-seeking behaviour (130138); however, there have been few studies addressing POP and healthcare-seeking behaviour,
and also patients knowledge about POP.
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Earlier studies have indicated that womens knowledge about pelvic floor disorders is of importance
in seeking medical advice (130-131, 139). The level of knowledge of pelvic floor disorders and the
impact of knowledge on healthcare-seeking behaviour was investigated in a multi-ethnic cohort
of women (140). The findings indicated that there was greater patient awareness and education
in white women than in non-white women, resulting in more frequent healthcare-seeking and
reporting of symptoms. The knowledge barrier was found to be responsible for low care-seeking
for UI in non-white (140) and Middle-Eastern women (141-142).
In Western countries, the hesitancy to seek medical advice regarding UI has been found to
be lack of knowledge about causes and about the availability of treatment, the embarrassment
of talking about incontinence, and the belief that incontinence is a normal part of ageing (130134). In a cross-sectional survey of 2,310 women with UI, factors significantly associated with the
decision to seek treatment were a duration of symptoms of more than 3 years, having a history
of noticeable accidents, and impaired quality of life scores (135).
Studies of patients with chronic diseases such as arthritis and diabetes have shown that improvement in patient knowledge about the condition leads to improved compliance regarding treatment
and can lead to behavioural change (143-144). As in the case of chronic diseases, improvements
in patient knowledge about POP and UI may lead to an increased amount of healthcare-seeking
behaviour in patients and, as a result, the physical and psychosocial morbidities associated with
POP and UI may be reduced (139).
PHYSICAL AND PSYCHOLOGICAL WELL-BEING RELATED TO POP
Prolapse has a significant influence on the quality of a womans life (8, 145-146). Women who
consider themselves as being symptomatic generally have a significantly higher stage of prolapse
and poor QOL (145). Womens well-being (body image, sexual function, pelvic floor related
symptoms, QOL, depressive symptoms) are improved after both surgical and conservative treatment of POP (146-149). Jelovsek et al. found that women with advanced POP (of stages III or
IV) are more likely to feel self-conscious and less likely to feel physically and sexually attractive
than healthy controls (8). Age, race, parity, previous hysterectomy, and medical co-morbidities
were not found to be significant confounders in that study.
QUANTITATIVE STUDY DESIGN
Most applied study designs include randomised controlled trials (RCT), case-control studies,
and cohort and cross-sectional studies.
In RCT, comparable individuals are randomly assigned to a treatment group or a control
group and are observed for a specific health-related outcome (150). Ethical aspects must be fully
addressed in such studies. RCT studies are considered to be the golden standard of research design, most probably because they provide the most convincing evidence of relationships between
exposure and effect (151). RCT study may be conducted in a single-blinded or a double-blinded
fashion to account for the placebo effect and to reduce the introduction of bias due to patients
and clinicians conceptions (151).
Case-control studies and cohort studies have opposite approaches. The cohort study begins
with the identification of a population (cohort) with an exposure of interest and a non-exposed
population for comparison. The investigators then follow the cohort over time and determine
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the outcome in each group. In a case-control study, the researchers identify individuals with a
disease or a health outcome of interest and a control or comparison group; exposures and risk
factors are evaluated in these individuals. In a case-control study, a variety of exposures can be
studied whereas in a cohort study, a variety of diseases can be studied (151). Cohort studies are
usually prospective but they can also be retrospective.
In cross-sectional studies, subjects are sampled at a fixed point or period of time, and then
the associations between the concurrent presence or absence of risk factors and diseases are investigated (151).
Table 2 lists the advantages and disadvantages of different study designs.
Table 2. Advantages and disadvantages of different study design (modified from Greenberg et
al. and Fletcher et al.).
Study design

Advantages

Disadvantages

RCT

Best evidence study design


No inclusion bias (using blinding)
Comparable groups

Large sample size


Long term follow up (possible losses)
Expensive
Ethical concerns
Compliance

Case-control

Inexpensive
Small sample
May be completed rapidly
Optimal for rare diseases
Good for study of chronic diseases

Identifying controls may be difficult


More susceptible to selection bias
Difficult to establish temporal relationship
between exposure and disease

Cohort

Direct calculation of risk ratio


Information on incidence of disease
Able to study multiple exposure and multiple outcomes
Minimizes bias

Time-consuming
May require large sample size
Expensive
Not efficient for study of rare diseases
Require long follow up period
Potential for loss to follow up

Crosssectional

Usually use population-based samples


Use to assess the prevalence
Inexpensive
Useful for public health planning

Not strong at showing cause-effect relationship

QUALITATIVE RESEARCH IN UROGYNAECOLOGY


Qualitative research is becoming more prominent in medical research (152). Most research in
urogynaecology uses quantitative methods; however, editorials have advocated a greater role for
qualitative research as a way to address both clinical and psychosocial issues (153-154). Despite
the fact that qualitative research can offer valuable insights into urogynaecological problems, it
has struggled to gain acceptance in this field (155).
Qualitative research an overview

Qualitative research is an enquiry process for understanding of a social or human problem (156).
The researcher analyses informants own words, and reports detailed viewpoints of informants
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(157). Qualitative research allows the discovery of unexpected issues that might not have been
detected by a pre-defined set of questions (152).
The most common tools for collection of data in qualitative research are interviews, which
can be unstructured or semi-structured (152). In unstructured interviews, people usually feel
more open to talk and unexpected information may appear. The disadvantage of unstructured
interviews is the fact that the researcher has minimal control over the order of the research topics
that arise. In semi-structured interviews, an interview guide is used which can give more control
over topics of interest (152).
Qualitative and quantitative research

Qualitative and quantitative methods are different tools in health research, and their applicability depends on the research question (152, 156). The qualitative and quantitative approaches
complement each other in this kind of research.
Qualitative and quantitative methods have different research processes: inductive and deductive (152). The inductive approach in qualitative research refers to discovering something new,
perhaps with the result that hypotheses can be generated, but the aim of research is not to prove
them to be true or false. Quantitative research takes a deductive approach, meaning that it tests a
hypothesis. This method is suitable for measuring a certain condition or well-described phenomenon in a population, and when the research field has already been explored and the researcher
wants to verify a hypothesis (152). Qualitative methods are suitable when the research field is
unexplored, or when a flexible approach is required for exploring the unexpected, or when it is
desirable to look into an issue in depth (152). A qualitative study may produce ideas, theories,
and hypotheses that can be tested in a quantitative study (156).
Some central concepts in qualitative research projects are natural setting, emergent design,
saturation, and purposive sampling (152). Research can be undertaken in a variety of settings
(the specific places where information is gathered). Qualitative researchers are especially likely to
engage in natural settings because they are interested in the context of peoples lives and experiences (158). A design that unfolds in the course of a qualitative study as the researcher makes
ongoing design decisions, reflecting what has already been learned, is called emergent design
and is a way of enhancing the quality of the research (152, 158). In qualitative methods, data
are commonly collected until a level of saturation has been achieved, meaning that no further
substantial information can be obtained by further recruitment of informants (152). Sampling in
qualitative research focuses on purposive sampling, i.e. a striving for maximum variation in, for
example, background characteristics of the informants included in a study (159). Quantitative
research focuses on probability sampling; that is, everyone in the study population has an equal
chance of being selected (152).
One inevitable issue in qualitative research is the interaction between the researcher and the
participants (152). The researchers interest can influence the research process. In quantitative
research, certain precautions are taken to eliminate subjectivity (159). However, the researcher
is always a subject in qualitative research (152)

. Taking advantage of the researchers earlier experiences to enhance the quality of data is stressed (160), and it is important that researchers
pre-understanding and expectations should be debated openly (152).

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Qualitative content analysis

Content analysis (CA) is analysis of themes and patterns that emerge in the narrative content
(158), and it deals with both manifest and latent content in a text (161). The manifest content
refers to what the text says and the latent content refers to what the text implies (161). Focus in
CA is the subject and the context and emphasize differences between and similarities within codes
and categories (161). Three different approaches have been identified in qualitative CA (162):
conventional CA, directed CA, and summative CA. Conventional CA is usually appropriate
when existing research literature on a phenomenon of interest is restricted and coding categories
gain from the textual data (162). Directed CA is appropriate when existing research literature
on a phenomenon is incomplete and would benefit from further description. This approach is
a deductive one, and the existing theory is a guide for the coding process (162). Summative CA
starts with identification and quantification of certain words or content in a text, followed by
interpretation of the underlying context.
Trustworthiness in qualitative research

In qualitative research the concepts credibility, dependability, transferability and confirmability


are used to define the various aspects of trustworthiness (159, 161).
The credibility of findings in qualitative research depends on the collection of data as well
as on the analysis of data, i.e. how well the data and the process of analysis address the original
intention (159). Choosing participants with a range of experiences increases the possibility of
approaching the research question from different angles (161). A well-structured methodology
with stepwise procedures in the content analysis enhances the credibility in the analytical phase.
Another aspect of the credibility of research findings is the degree of agreement between coresearchers and participants (161). The value of dialogue between co-researchers and of seeking
agreement has been defended in qualitative research (161). The intention is to determine whether
co-researchers agree with the way the data have been labelled (161).
Dependability is another aspect of trustworthiness, meaning that the study must adjust to new
forms of input obtained during the study period (161, 163). Based on the new data obtained,
the alterations in the researchers decisions during the analysis process can be discussed by open
dialogue to judge the consistency of the content over time (161).
Transferability refers to the extent to which the results of a study can be transferred to other
settings (159, 161). By giving a clear description of informants characteristics, culture, and
context, readers can be provided with enough information to decide whether the findings are
transferable to another context (161).
Confirmability in qualitative research implies that the neutrality of a research project is focused
on the data and the interpretation of the data, instead of on the researcher as a subject (161).
Describing the analytical procedure and giving quotations from the transcripts is a way of verifying that the findings are derived from the data and that they are not a result of the researchers
preconceived ideas or assumptions (159, 163).
THE HEALTHCARE SYSTEM IN SWEDEN
Sweden has 9 million inhabitants and is the third largest country in Western Europe in terms
of area. Sweden has Europes proportionally largest elderly population, with over 5% of the
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population in the age stratum of 80 years or older. Most of the healthcare services in Sweden
are public, and everyone has an equal right to such services (164). In Sweden, each inhabitant
has a unique personal identification number. The database of the Swedish Inpatient Register at
the National Board of Health and Welfare (NBHW) contains discharge data according to the
International Classification of Diseases (ICD-10) codes for specific disease diagnoses, including
surgical procedures for all admissions at public hospitals (165).
HEALTHCARE QUALITY REGISTERS IN SWEDEN
History

A system of national quality registers has been established in the Swedish health and medical
services in the last decades. The Swedish Association of Local Authorities and Regions (SALAR)
and the NBHW have collaborated to support the development and use of National Quality Registers (166). This collaboration is looked after by the Executive Committee for National Quality
Registers. This committee also includes representatives from the Swedish Society of Medicine
and the Swedish Society of Nursing. Until 2007, the quality registers were under the auspices of
the NBHW. From 2007, SALAR has taken on the primary responsibility for the development
and financing of the registers.
There are about 70 health quality registers in Sweden. Development of the registers has been
done by representatives of the professional groups that use them. National Quality Registers
contain data on patient diagnosis, treatment interventions, and treatment outcomes. These are
monitored annually and approved for financial support by the Executive Committee. Many
registers cross-match the register data with those in the national health databases, for example,
the Cause of Death register, to enhance their analytical capacity further.
Aim of the quality registers

The main aim of health quality registers in Sweden is quality control of healthcare and improvement of the quality of healthcare in the Swedish health services. The secondary aim of the registers is to be used for research on health and medical services in accordance with SFS 2008:335,
capture 7, 5 (167).
Data from healthcare quality registers make it possible to follow up and develop medical healthcare in Sweden. One of the purposes of the national quality registers is to provide benchmarking
data, i.e. to enable individual hospitals to measure the treatment results regarding certain conditions and to compare them with the Swedish national average results, and with corresponding
results from other Swedish hospitals (164). Large quantities of data that are collected annually
in the national healthcare quality register make it possible to detect problems or complications
rapidly. Register data can be used for improvement of the quality of health services. The uses
of healthcare quality registers have become wider since some registers have started to include
patient-perceived quality of life in addition to the medical data.
The Swedish National Quality Register for Gynaecological Surgery
(Gynop-register)

The Gynop-register was established in 1997 by jointly agreement between the Swedish Society
of Obstetrics and Gynaecology (SFOG) and the NBHW with a view to quality control of en14

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doscopic surgery (168). The register has been expanded since then and currently includes six
sections covering different surgical areas of gynaecology. Initially, hysterectomy due to benign
conditions, ovarian surgery, and intrauterine surgery (endometrial ablation) were included in the
Gynop-register. Since 2006, malignant gynaecological surgery, incontinence surgery, and POP
surgery have also been included in the register. Data in the Gynop-register are cross-matched
with the Cause of Death Register, the register of the total population, and the Inpatient Register
to enhance the validity and analytical capacity of the data (168).
The Board of the Gynop-register consists of one manager, six gynaecologists (each one of
whom is responsible for a specific section in the register), one member of SFOG, one chief representative from one gynaecology clinic, and one Board secretary. Vsterbotten County Council
is the authority responsible for the Gynop-register. The main financiers are SALAR and the
participating clinics.
Inclusion of patients in the Gynop-register

Patients with a planned operation are included in the register. In order to avoid selection bias for
registration of patients in the Gynop-register, inclusion of the patients is done by the operationsplanner nurse or secretary. In accordance with the regulations of the management of National
Healthcare Quality Registers, patients receive written information about the register and they have
an opportunity to decline participation (167). All data extracted from the register for analysis is
encoded, and it is not possible to identify any of the patients. Patients have the right to ask for
their register record once a year.
During the period 2007 to 2010, the board of the Gynop-register offered an inspection visit
to all gynaecological clinics, and in total 15 clinics (belonging to both university and county
hospitals) accepted the offer and inspections were performed thereafter. The aim of the visit was
to determine the proportion of patients with a planned surgery included in the register. The
number of gynaecological surgeries performed (according to the clinics surgical register) was
compared to the number of surgeries registered in the Gynop-register at the clinic under inspection. According to the results of the inspections at the clinics, the mean proportion of patients
included in the register was found to be 96% of eligible patients.
Data collection procedures in the Gynop-register

Data in the register are collected through patient questionnaires and forms completed by
surgeons (169). Until 2005 patients received two follow-up questionnaires, two months and
six months after surgery. Since 2006 the one year follow-up questionnaire has replaced the
six-month follow-up questionnaire. Table 3 shows the data collection procedure in the Gynopregister. The questionnaires have been validated through collaboration with the Department of
Applied Educational Science at Ume University, Sweden. Validated questionnaires for identification of symptoms related to POP and UI are included in the preoperative and follow-up
questionnaire (64, 127).

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Table 3. Data collection procedure in the Gynop-register.


Questionnaire

Collection time of
the questionnaire

Questionnaire data content

Preoperative patient
questionnaire

At decision for surgery

Sociodemographic data, health status, and


medical assessment of patients health data and
symptoms reported by the patients

Preoperative form
(Gynecologist)

At decision for surgery

History; physical and gynecological examinations

Operation form
(Gynecologist)

Directly after surgery

Surgery data

Postoperative form
(Gynecologist)

After discharge

Course of events during hospital stay

Two-month followup questionnaire


answered by the
patients

Sent 6 weeks after surgery.


Usually completed and registered approximately 8 weeks
postoperative. 2 reminders
are sent when necessary

General and medical follow-up questions, wellbeing and surgery-related complications, recovery,
and improvement; gynecologist assesses patients
answers

One year followup questionnaire


answered by the
patients

Sent 1 year after surgery.


2 reminders are sent when
necessary

Identical questions as in preoperative for urinary


symptoms, local symptom related to prolapse and
sexual activity. R
atings of satisfaction
; gynecologist assesses patients answers

The Urogynaecology Association (Uro-Arg) within SFOG is responsible for part of the content of
the patient questionnaires and surgeons forms. Since 2008, patients have been invited to answer the
questionnaire through the Internet. Patients who have an e-mail address can receive an e-mail giving the
password to a web link where they can answer the questionnaire. Patients who do not have an e-mail
address, or whose e-mail address is not requested, also have an opportunity to answer the questionnaire on-line through specific information given in the questionnaire that is sent by post. However,
patients who receive a questionnaire on paper rarely answer it on-line (< 5%). The overall response
rate for the patient questionnaire is over 90% and the surgeons form is completed in 90% of cases.
Coverage of the Gynop-register

Of 53 gynaecology clinics in Sweden, 43 (81%) currently participate in the Gynop-register. Of


the participating clinics, 37 (86%) clinics register data on POP surgery in the register. In order
to investigate the coherence between the number of patients were admitted to hospitals for POP
surgery and included in the Gynop-register and the number of patients included in the Swedish
Inpatient Register (165), a comparison was made between these two registers. In the Swedish
Inpatient Register, 5,017 patients were identified who underwent POP surgery during 2009
and the corresponding figure in the Gynop-register was 2,571 patients. Table 4 gives the coverage of the Gynop-register in the different counties in Sweden, and the number of patients who
underwent POP surgery during 2009 in each county. One can conclude that the Gynop-register
has good coverage of clinics performing surgery for POP in relation to all clinics performing
prolapse surgery in Sweden. The Gynop-register covers 51% of the patients undergoing surgery
for POP in the inpatient care.

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Table 4. Number of patients who underwent prolapse surgery during 2009 according to the
Swedish Inpatient Register and the Gynop-register.
County

A (n = 5017)

B (n = 2571)

Proportion
B/A (%)

Proportion of clinics participating in the prolapse


section of the Gynopregister (%)

Stockholm

928

Uppsala

182

99

54

100*

Sdermanland

146

33

112

143

127

100

Jnkping

181

195

107

100

Kronoberg

145

Kalmar

175

183

104

100

Gotland

34

stergtland

Blekinge

122

Skne

596

141

24

50**

Halland

245

84

34

50**

Vstra Gtaland

835

745

89

70**

Vrmland

196

rebro

142

135

95

100

Vstmanland

186

178

96

100

Dalarna

196

168

86

100

Gvleborg

163

161

99

100

Vsternorrland

91

65

71

Jmtland

65

64

98

100

66**

Vsterbotten

104

105

100

100

Norrbotten

173

99

57

66**

A: Number of patients in the Swedish Inpatient Register, B: Number of patients in the Gynop-register.
*Registration started in 2009.
**Inspections were performed by the Board of the Gynop-register. Among clinics being inspected a mean
registration rate of 96% (range 80100%) for registration of the data has been found.

17

18

Aims
The aims of the study were:
1. To investigate complications and patient-perceived outcomes of vaginal hysterectomy
for correction of uterovaginal prolapse (Paper I).
2. To investigate outcomes of cystocele repair surgery and patient satisfaction related to
different forms of anaesthesia (Paper II).
3. To elucidate womens experiences of vaginal prolapse and its effect on their daily lives
(Paper III).
4. To investigate perception of vaginal prolapse and healthcare-seeking behaviour among
women prior to gynaecological surgery (Paper IV).

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20

Subjects and methods


PAPER I
A cross-sectional, retrospective study was performed and data on subjects in the hysterectomy
section of the Gynop-register were included in the study. Subjects with uterovaginal prolapse
who had undergone vaginal hysterectomy from January 1997 to August 2005 were included. The
exclusion criterion was surgical correction other than vaginal hysterectomy. In total, 941 women
who had undergone vaginal hysterectomy because of uterovaginal prolapse were identified. Data
analysis was based on completed responses from the pre- and postoperative surgeons forms and
patient questionnaires (169). A two-month follow-up questionnaire was sent to 827 women, and
791 responded (95.5%). A six-month follow-up questionnaire was sent to 748 women, and 682
responded (91%). Twenty-two women were assessed by the responsible surgeons to be unable
to respond to the follow-up questionnaire due to language difficulties, advanced age, or mental
disorders, and a further 28 women refused to respond to the questionnaire (Figure 1).
Primary indication
prolapse
N=1019
Vaginal hysterectomy
due to prolapse
n=941
Responded
2 months follow up
n=791

No response
n=36

Responded
6 months follow up
n=641

Responded
6 months follow up
n=41

Excluded n=78
Undefined operation method (n=71)
Operation < 2 months before
database closed (n=7)

Departments of
gynecology failed to
send questionnaire n=64

Excluded n=50
Refused questionnaire (n=28)
or assessed unsuitable for
questionnaire by surgeon (n=22)

Figure 1. Selection of subjects eligible for the study

Data on patient characteristics, health status, and reported symptoms were retrieved from the preoperative patient questionnaire. Data on surgery and complications during surgery were collected
from the surgeons operative questionnaire. Data on course of events during hospital stay were
extracted from the surgeons form that was completed postoperatively. Data on patient-reported
complications (unexpected events) were collected from the two-month follow-up questionnaire.
In the preoperative and the six-month postoperative patient questionnaires, questions relating
to symptoms of vaginal protrusion/ vaginal heaviness and urinary problems were requested in
order to evaluate the effect of surgery. The questions regarding urinary problems and incontinence
contained yes or no answers. Patients responses enabled us to identify four groups of urinary
problems: (1) incontinence without urgency, interpreted as being stress incontinence; (2) urgency
21

Subjects

and methods

without incontinence, interpreted as being urgency problems; (3) urgency and incontinence,
interpreted as being urgency incontinence; or (4) no reported urinary symptoms. Sexual activity
was reported by answering the question have you had coitus in the past three months? Symptoms regarding dyspareunia, sensation of vaginal heaviness were reported in a visual analogue
scale (VAS) of five grades, both preoperatively and postoperatively. The scale measured from 0
to 50 mm with 0 corresponding to complete absence of symptoms and 50 corresponding to
unbearable symptoms.
NON-RESPONSE ANALYSIS (PAPER I)
Medical records were retrieved for 36 women for whom a follow-up questionnaire was sent but
no answer was recorded in the register. One subject had been exposed to a severe complication
(intra-abdominal haematoma) before discharge from the hospital, which was subject to reoperation and was reported in the postoperative discharge form by the surgeon. Two complications
considered as being mild (urinary tract infection and vaginal vault haematoma with spontaneous
drainage) were also noted. Of the patients without discharge data (n = 22), 17 had reported a
recovery without complications in the two-month followup questionnaire. The medical files did not reveal any
complications for the remaining five patients. We did
not find any complications during their hospital stay
that were reported by the patients but not registered by
the surgeons.
PAPER II
A cross-sectional, retrospective study was performed.
Women who underwent surgery for cystocele (without
use of mesh) and who were registered in the prolapse
section of the Gynop-register were included in the study.
The study period was from January 2006 to June 2009.
During this period, 33 gynaecological clinics registered
POP surgery in the Gynop-register. Figure 2 presents
the catchment area for the participating clinics during
the study period.
We found 1,739 subjects who had undergone cystocele
repair surgery during the study period. However, the form
of anaesthetic method used was not registered in all cases.
To eliminate selection bias regarding registration of anaesthetic methods, clinics that had more than 40% missing
data regarding registration of the currently used anaesthetic
method were excluded from the study (representing 175
operations in four hospitals). The cut-off point of 40% was
chosen because it was found to be the largest gap between
hospitals regarding missing registration of anaesthesia data.
Of 1,564 eligible women, 200 were excluded from the
22

Figure 2. The coloured area represents the catchment area for the
participating clinics during the study
period.

Subjects

and methods

study because of lack of information on the anaesthetic method used. Subsequently, 1,364 women
were identified with complete information.
Data from forms completed by the surgeon perioperatively and postoperatively and patient
questionnaires were analysed. The following variables were extracted from the preoperative and
operative surgeons form: grade of physical status of the patient (according to the American Society
of Anaesthesiologists physical status classification system; ASA); expected operative condition;
recurrence of cystocele; anaesthesia method; estimated operative time and blood loss; and perioperative complications. The following variables were extracted from the postoperative surgeons
form: length of hospital stay; use of in-dwelling catheter; and complications during the hospital
stay. From the preoperative patient questionnaire, data on patient characteristics, symptoms of
UI, and general health were collected. The variables retrieved from the two-month follow-up
questionnaire were: patient-reported complications for which the patient sought medical care;
symptoms of UI; patients self-estimated duration of time to return to daily activities (ADL);
number of days using pain-killer medication (pills); the patients estimated length of hospital stay;
the patients condition after surgery; and whether the patient would recommend this surgery to
someone else. Patients statements on whether they would recommend the surgery to other patients
(yes, no) and their condition after surgery (improved, not improved) enabled us to define their
degree of satisfaction with the procedure (satisfied, dissatisfied). Patients were considered satisfied
if they could recommend the surgery to others and if their condition had improved after surgery.
In total, 1,194 subjects received a follow-up questionnaire two months after surgery and 1,091
(91%) responded. Of the 273 women who had not responded to this follow-up questionnaire,
170 had undergone surgery less than 2 months previously and thus had not had any opportunity
to answer the questionnaire.
When paper II was published, we did not have the one-year follow-up data on results after
surgery, in which local symptoms, e.g. sense of vaginal bulging, were asked about and stated by
the subjects. Since the one-year follow-up data are now available, we chose to present the data
concerning local symptoms related to POP. The variable do you feel something bulge from the
vagina? was extracted from the follow-up questionnaire. This question was answered by patients
in both the preoperative and the follow-up questionnaire one year after surgery. The response
options never and almost never were considered to be no, meaning that they did not feel a
vaginal bulge. The response options once to three times per month and once to three times per
week and daily were considered to be yes, meaning that they felt a vaginal bulge.
Univariate and multivariate regression analysis was conducted to investigate the characteristics
that were significantly associated with patient satisfaction.
PAPER III
A qualitative study was conducted using content analysis. An interview guide was developed using open-ended questions addressing different topic areas, based on the scientific literature and
the clinical experiences of the research group in this medical field.
The informants were women with POP of stage II or more according to the POP-Q classification system (5) and who were on the waiting list for primary surgery at a hospital in northern
Sweden. Initially, eight women were approached. They were contacted by telephone by the author
and informed about the aims of the study, and were asked to participate in an interview. Sub23

Subjects

and methods

sequently, an information letter was sent to the informants who had said that they were willing
to participate in the study, and the information letter also emphasised that participation in the
study was voluntary. Recruitment of the informants was according to purposive sampling, i.e.,
aiming at the greatest variation in characteristics such as age, occupation, parity, BMI, and marital status in order to capture extensive narratives from the informants. Verbal informed consent
was obtained from all the informants before the interview was conducted. The interviews were
recorded on tape and transcribed verbatim.
After eight interviews with parallel analysis, a revision of the interview guide was made as
part of the emergent design, and four additional informants were recruited to the study. Data
were collected until saturation was achieved, that is, when no significant new information was
obtained by conducting further interviews. Emergent design and saturation of the collected data
was inspired of Grounded theory. After 12 interviews, the saturation of data related to the study
question had probably been achieved; however, two final interviews were conducted to ensure
that no substantially new experiences would come to light. The data were analysed according to
manifest and latent content analysis, which is a stepwise process (161). In the first step, the text
was read thoroughly to obtain a sense of the whole and to identify the content. Secondly, the text
was divided into units of meaning to make the text shorter, while keeping its core message. At
the third step, the meaning units were condensed and labelled with codes. Fourthly, the various
codes were compared on the basis of similarities and differences and sorted into two categories
and 11 subcategories. The final step of the analysis was to identify a theme. To validate the findings, the findings at the different steps of the analysis were discussed within the research group
until consensus was achieved.
My pre-understanding

I have studied medicine in Sweden and I am a specialist in obstetrics and gynaecology with clinical
training in Sweden. My main field is urogynaecology which includes pelvic floor-related conditions, e.g. POP and female urinary problems. I have worked in this clinical field since 2003. I
participated in an academic course on content analysis in 2009.
PAPER IV
A prospective, cross-sectional questionnaire study was conducted. The exclusion criterion was
surgery for recurrence of POP. Women with planned surgery for POP were included (n = 214).
Women with planned surgery for hysterectomy (benign indication; n = 186) or incontinence (n
= 161) were chosen as reference groups. The study period was from March to June 2010. Based
on the findings in paper III, a questionnaire was developed and validated (Appendix 1). The
questionnaire consisted of open-ended and multiple-choice questions in which the participants
could choose one or more options. Participants had the opportunity to write an answer of their
own in a free space if none of the available options were suitable. The questionnaire included
items requesting the womens description of POP and its causes, healthcare-seeking behaviour,
and sources of information on their own condition. In addition, information on former education and duration of symptoms was provided by the patients on the questionnaire form. If the
duration of symptoms was reported to be more than one year, the participants were requested
to describe the reasons for not seeking health care earlier and their current reasons for seeking
24

Subjects

and methods

help, in two multiple-choice questions. The questionnaire also contained questions regarding
the information women received from the gynaecologist concerning effects of surgery on urinary
symptoms, bowel symptoms, and sexuality. However, these data from the questionnaire are not
presented in this thesis. All multiple-choice questions included the open response option other
reasons, whereby participants had the opportunity to write an answer of their own, either alone
or in conjunction with marking (an) other option(s). Comments were coded as: (i) marking an
available option (s) and writing the same option as well; (ii) not marking an available option,
but writing the same or a corresponding alternative instead in own words; (iii) marking other
reason and/or producing an answer that was beyond the available options. In case of the second
alternative, the available option was registered. The pre-existing options covered 9199% of the
answers produced.
Description of vaginal prolapse was investigated by two open-ended questions: what is vaginal
prolapse? and what can cause vaginal prolapse? Responses to the open-ended questions were
coded and similar codes were classified in the same category.
We used the Gynop-register as a tool for the data collection since 70% (n = 37) of the gynaecology clinics in Sweden use the register for POP surgery, and 68% (n = 25) of the participating
clinics use web-based questionnaires (WBQ) in addition to paper questionnaires for data collection. The questionnaire was distributed along with the preoperative questionnaire (on-line
or paper). Eligible participants received written information about the aim of the study, and
they were informed that the questionnaire was for research purposes and that participation was
voluntarily. They were also informed that the healthcare providers would not have access to the
content of the questionnaire.
Eligible participants in the study were women who reported an e-mail address and responded
a WBQ (n = 561). However, seven hospitals distributed the questionnaire in the paper format
to women who were willing to participate but who did not have an e-mail address (n = 79).
The hospitals were chosen based on their different geographic locations and they included both
university and county hospitals. Women who received a WBQ answered our questionnaire in
95% of cases.
STATISTICAL METHODS
All statistical analysis in papers I, II, and IV were performed using the SPSS software package
version 11.5, 16, or 18.
Paper I and IV

Categorical variables were analysed by Pearsons chi-squared test and parametric data were analysed by t-test. Holms corrected Bonferroni method was applied to control for multiple testing.
A p-value less than 0.05 was considered significant.
Paper II

For comparison between groups, categorical variables were analysed using Pearsons chi-squared
test, and parametric data were analysed using t-test. For continuous variables with a skewed distribution, the Kruskal-Wallis and Mann-Whitney tests were used. ANOVA was used to analyse
normally distributed variables. Holms corrected Bonferroni method was used to correct for
25

Subjects

and methods

multiple testing. Univariate and stepwise multivariate logistic regression analyses were performed
to investigate the association between different variables and increased patient satisfaction.
Continuous variables such as age and hospitals were dichotomised. Age was dichotomised at 50
years (approximate menopausal age). The variable hospital was dichotomised into two categories
constituting hospitals either using LA in less than 50% at cystocele operations, or more than or
equal to 50% (50% was the largest gap between the hospitals for use of LA). For the univariate
analysis, the crude odds ratios (OR) with their corresponding 95% confidence intervals (CI)
were calculated. All statistically significant variables (p < 0.05) in the univariate analysis were
tested by performing multivariate logistic regression analysis. Significant variables were entered
in a stepwise manner. A linear regression analysis was conducted, weighted by number of patients
(n = 1,364) with proportion of use of LA per hospital as independent variable and proportion
of postoperatively inserted urinary catheter and length of hospital stay as dependent variables.
ETHICS
All studies were approved by the Regional Ethical Review Board in Ume, Sweden (Dnr. 08-076,
Dnr. 2010-31-32).
The main advantage of using register data is that they already exist. Thus, the time spent on
data collection for studies is shorter than the time needed for primary data collection (170).
Sweden has a long tradition of healthcare quality registers and population-based registers. The
Cancer Register was established in 1958 and the Gynop-register started to collect data in 1997.
The legislation of using register data for research purposes has become more elaborate in the last
decade due to issues regarding integrity of the individual (167). A definite requirement is that
subjects should not be identifiable throughout the research process.
Patients with a planned surgery were included in the Gynop-register. In accordance with
the regulations of the management of National Health Quality Registers, patients had received
written information on the register and they had had an opportunity to decline participation in
the register. All data extracted from the register for analysis were coded and individual patients
could not be identified. Information on individual patients is protected according to 13 of the
Swedish Personal Particulars Law (PuL). Patients have the right to demand that their personal
information be erased from the register. In addition, they have the right to demand a register
record and to request that incorrect information should be corrected (167).
In the qualitative study (Paper III), eligible participants received oral and written information
on the aims of study before deciding whether or not to participate. Informed consent was obtained
before the interview took place. The participants were also informed that they could withhold
their participation at any time without affecting their further treatment. The hidden identity and
confidentiality of the participants was assured throughout the research process.
In paper IV, eligible participants received written information on the aims of the study, including
assurances that the questionnaire was for research purposes and that participation was voluntarily.
They were also assured that their individual integrity would be protected. They were also informed
that none of the healthcare providers would have access to their answers to the questionnaire.

26

Results
PAPER I
Vaginal hysterectomy was performed as the single operation in about 80% of cases and an additional procedure (repair of cystocele or rectocele, anti-incontinence surgery) was performed
in 17% of the cases. Complications resulting in reoperation or re-admission were defined as
severe complications, and were reported in 3% of cases. The complications consisted mainly of
intra-abdominal bleeding and vaginal vault haematomas or infections. We found no statistically
significant differences between patients with severe complications and the rest of the study sample
concerning medication, preoperative functional state according to the ASA, operative difficulties
such as adhesions or presence of endometriosis, or perioperative complications. Subjects with
severe complications were younger (p = 0.001), had fewer concurrent diseases (p = 0.007), and
had a shorter operative time (p = 0.003) than women with no complications. Furthermore, there
were no statistically significant differences in frequency of reported complications between women
who had vaginal hysterectomy alone and women who had a concomitant procedure (p = 0.93).
Patient-reported time to return to daily activity showed no differences between age groups
and over 50% of the women in each age group had returned to their daily activities within one
week of surgery.
Effects of surgery on sexual activity and urinary symptoms were evaluated using identical
questions and these were answered by the subjects both preoperatively and six months postoperatively. Patient-reported sexual activity is listed in Table 5. The number of women reporting
intercourse had increased by 20% (from 244 to 292 cases; p = 0.006). The number of women
who had been sexually inactive prior to surgery and who had resumed sexual activity after surgery
was four times higher than women who had been sexually active prior to surgery and who had
not resumed sexual activity six months postoperatively. Prior to the surgery, only 3% (n = 31)
reported dyspareunia that was estimated to be 3 according to VAS and the corresponding figure
after surgery was 2% (n = 18). The difference was not statistically significant.
Table 5. Sexual activity* reported by patients preoperative and postoperative.
6 months postoperative
Yes, n
Preoperative

Yes, n
No, n
Total, n

228

No, n
16

Total, n
244

64

312

376

292

328

620

*Sexual activity was reported by answering to the question Have you had coitus in the past three months?

Table 6 lists patient-reported urinary symptoms. A total of 679 subjects answered the questions
regarding urinary symptoms in both the preoperative and the postoperative questionnaire. In
27

R e s u lt s

the preoperative questionnaire 259 subjects (38%) reported urinary symptoms such as urgency,
urge incontinence, and SUI. Six-month postoperatively, this response was reduced to 30% (n =
204) and the differences was statistically significant (p = 0.002). However, among women who
had not had urinary symptoms before surgery, 20% reported urinary symptom postoperatively.
Approximately 50% of the subjects who had UI preoperatively became continent postoperatively;
however, 14% (76/545) developed UI and most of them had de novo stress incontinence (58/545).
Urge incontinence was reduced by 60%; however, almost 50% of the subjects with postoperative
urge incontinence were continent preoperatively. Symptoms of urinary urgency were reduced in
50% of those reporting it preoperatively, but half of those with postoperative urgency had not
reported symptoms of urgency preoperatively. The number of subjects complaining of SUI was
doubled (n = 104) compared to preoperatively (n = 50). Postoperatively, new onset of urgency,
urge incontinence, and SUI was reported by 6%, 3%, and 11% of patients, respectively.
Table 6. Urinary symptoms reported by patients, preoperative and six months postoperative.
6 months postoperative
No reported
symptoms

Urgency

Urge
incontinence

Stress
incontinence

Total

336 (49.5)

31 (4.6)

11 (1.6)

42 (6.2)

420 (61.8)

Urgency

78 (11.5)

24 (3.5)

7 (1)

16 (2.4)

125 (18.4)

Urge incontinence

40 (5.9)

6 (0.88)

15 (2.2)

23 (3.4)

84 (12.4)

Stress incontinence

21 (3)

2 (0.3)

4 (0.4)

23 (3.4)

50 (7.4)

475 (70)

63 (9.3)

37 (5.4)

104 (15.3)

679 (100)

Preoperative
No reported symptoms

Total

All value are expressed as number (%)

Of the subjects who rated the symptom of vaginal heaviness on the VAS scale as being above 80%
of the length of the scale, i.e. VAS 4 and 5 (n = 262) preoperatively, 73% expressed no symptoms
of heaviness in the six-month follow-up questionnaire (95% CI: 2.322.63; p < 0.001), and 81%
had no symptoms irrespective of the previous grade of heaviness.
PAPER II
The background characteristics of the subjects who underwent surgery under different forms of
anaesthesia showed that the subjects who had been exposed to surgery using general anaesthesia
had been younger, healthier, and had smoked more frequently.
We found a wide variation in the prevalence of use of LA in cystocele surgery in relation to the
cystocele operation volume per hospital. Length of hospital stay, duration of use of postoperative
pain-killing drugs, and time to return to daily activity were shorter in patients who underwent
operation under LA compared to one or both of the other two forms of anaesthesia (p < 0.001,
p < 0.001, and p = 0.012, respectively). In-dwelling catheter used less frequently in women who
underwent surgery with LA compared to women undergoing surgery with the other forms of
anaesthesia (p < 0.001). There was no significant difference regarding perioperative complications and patient-reported complications between different forms of anaesthesia (p = 0.4 and p
= 0.35 respectively). After conducting a weighted linear regression, we found that an increase in
the proportion of use of LA by 1% decreased the proportion of inserted in-dwelling catheters by
28

R e s u lt s

0.5% (95% CI: -0.778 to -0.25; p < 0.001). The model explained 38% of the variation in the
proportion of inserted in-dwelling catheters. Furthermore, an increase in the proportion of use
of LA by 1% reduced the length of hospital stay by 0.007 days (95% CI: -0.013 to 0; p = 0.029).
The model explained 17% of the variation in length of hospital stay. By excluding one hospital
(an outlier), 27.6% of the variation could be explained (p = 0.005).
In order to evaluate the effect of surgery on symptoms of UI and related to anaesthesia, subjects who reported UI pre- and postoperatively were investigated (n = 978). UI (of any kind)
was resolved in 43% of subjects who reported this condition preoperatively (n = 480); however,
11% developed UI postoperatively (Table 7). There was no significant difference in the forms of
anaesthesia between the subjects in whom symptoms of UI had developed and those in whom
they had disappeared.
Table 7. Urinary incontinence reported by patients before and after surgery for cystocele.
Incontinence postoperative
Yes, n
Incontinence preoperative

No, n

Total, n

Yes, n

273

207

480

No, n

56

442

498

Preoperatively, 1,095 subjects had reported local symptoms including sensation of a vaginal
bulge (LA, n = 411; Regional anaesthesia (RA), n = 306; general anaesthesia (GA), n = 378). Of
these patients, 63% (n = 688) did not have this symptom one year after surgery (LA, n = 282;
RA, n = 201; GA, n = 205; p = 0.11). However, 23% (n = 250) of the subjects with preoperative
symptoms of vaginal protrusion had reported a persistent symptom one year after surgery (LA,
n = 109; RA, n = 66; GA, n = 75; p = 0.18). There was no significant difference regarding the
form of anaesthesia.
We conducted a univariate and multivariate regression analysis to investigate the characteristics
that were significantly associated with patient satisfaction. Relevant variables related to patient
satisfaction were tested one by one in separate univariate analyses. In the univariate analysis,
variables with significant association were age, length of hospital stay, surgery due to relapse,
and patient-reported complications. These significant variables were tested in the multivariate
logistic regression analysis and entered in a stepwise approach. At this stage of analysis, age (
50 years) and patient-reported complications turned out to be independent variables for patient
satisfaction (OR 3.05; 95% CI: 1.366.82 and OR 0.21; 95% CI: 0.120.36, respectively).
There was no association between patient satisfaction and the anaesthesia method. There was a
correlation between advanced age and/or few reported complications on the one hand and high
patient satisfaction on the other.
PAPER III
In-depth interviews of subjects with POP who were awaiting surgery revealed the process from
recognition of vaginal prolapse to action, which was seeking healthcare. The theme defining this
process was labelled process of comprehension and action. The main findings of this study were
identification of two categories and 11 sub-categories acting as promoting or restraining factors
to seeking healthcare. Categories were labelled obstacles to seeking healthcare and facilitators to
29

R e s u lt s

seeking healthcare. Subcategories connected with a category had their main actions as facilitator or
obstacle. However, some of the subcategories also exerted the opposite effects, but to a lesser extent.
Factors exerting a negative influence on healthcare seeking were:
Absence of information at the individual level, as well as in a societal arena.
Blaming oneself for having prolapse due to not being active in pelvic floor training and
because of all the heavy physical work performed earlier in life.
Feeling ignored by the doctor at previous consultations and their symptoms had not been
confirmed, which made the subjects doubt their own perceptions of the condition.
Prolapse was considered a covert condition; subjects were uncertain about what condition
they were suffering from until the vaginal mucosa was exposed.
Informants found different coping mechanisms in order to adapt to successive impairment.
Vaginal prolapse was seen to be a condition of relatively little importance compared to
other medical conditions, or other problems they experienced in their social lives. The
subjects tended to trivialise the symptoms and to de-prioritise their own health.
Factors facilitating healthcare-seeking action were:
Through supportive communication with partners or others who were more knowledgeable
about the condition, the subjects were confirmed and supported to seek medical advice.
Vaginal prolapse was perceived as a sign of ageing by some subjects and they had difficulty
in accepting an ageing body.
Some subjects expressed that they felt sexually unattractive because of the alterations they
experienced in this intimate part of the body.
Feeling of a lump coming out or experience of the functional changes in the bladder
and bowel was expressed as having an unnatural body by the subjects.
When the subjects social and leisure activities were affected, they reached the point
of action which was seeking healthcare. Sometimes a triggering event such as postmenopausal bleeding or a triggering person (for example, a midwife) encouraged them
to seek healthcare.
PAPER IV
Of the 561 participants who answered a web-based questionnaire, duration of symptoms for
more than a year was reported by 64% of the women in the prolapse group, 94% in the incontinence group, and 77% in the hysterectomy group. Among the reasons for seeking healthcare,
interference with physical activity and increasing symptoms were the reasons most cited by all three
groups of participants (Table 8). Thirty per cent of participants in the prolapse group, 20% in the
incontinence group, and 40% in the hysterectomy group reported interference with sexual activity
as a reason for seeking healthcare. Almost 50% of the women in the hysterectomy group, 25%
of the women in the prolapse group, and 30% of the women in the incontinence group had not
found that earlier treatments had had any significant effect.
30

R e s u lt s

Table 8. Reasons for not seeking health care earlier and reasons for seeking health care
currently.
Groups of participants
Prolapse
(n = 138)

Incontinence Hysterectomy
(n = 152)
(n = 143)

P-value

Reasons for not seeking health care earlier


Condition was not troublesome

53 (38)

49 (32)

41 (29)

NS

Advised to wait*

34 (25)

27 (18)

28 (20)

NS

Did not know condition was prolapse

26 (19)

Embarrassed to talk about condition

22 (16)

53 (35)

2 (1)

< 0.001

Did not know condition could be treated

16 (12)

49 (32)

9 (6)

< 0.001

Family matters

13 (9)

18 (11)

13 (9)

NS

Unpleasant being gynecologically examined

10 (7)

7 (5)

11 (8)

NS

Could not take time off from my job

8 (6)

8 (5)

5 (4)

NS

Future pregnancy was planned

5 (4)

8 (5)

8 (6)

NS

Financial loss due to sick leave

3 (2)

4 (3)

3 (2)

NS

Other reasons

5 (4)

12 (7)

18 (13)

190

223

120

Total number of responses

0.001

Reasons for seeking health care currently


Increasing symptoms

76 (55)

86 (57)

77 (54)

NS

Interference with physical activity

60 (44)

100 (66)

72 (50)

< 0.001

Interference with sexual activity

44 (32)

34 (22)

56 (39)

0.01

Earlier treatment was not adequate

34 (25)

43 (28)

64 (45)

0.001

Encouraged by other person

25 (18)

42 (28)

22 (15)

0.017

Interference with work activity

22 (16)

33 (22)

61 (43)

< 0.001

Offered surgery earlier but decided to wait

16 (12)

7 (5)

18 (13)

0.044

Other primary reason

10 (7)

6 (4)

5 (4)

NS

Other reasons

3 (2)

Total number of responses

287

351

375

NS

All values are expressed as number of responses and percentage of women responding; n (%).
NS = nonsignificant
*By healthcare provider
Answered only by women undergoing surgery for POP
Including healthcare personnel
Applying Bonferroni, nonsignificant

The single most cited reason for not seeking healthcare earlier in the hysterectomy group and the
prolapse group was that the condition had not been troublesome. However, embarrassment in talking
about my condition and did not know that my condition could be treated constituted nearly 50% of
the responses in the incontinence group compared to the other two groups (p < 0.001). Twenty
per cent of the women in the prolapse group did not know that the symptoms were related to
31

R e s u lt s

prolapse. Furthermore, one out of five to one out of four women were recommended to defer
surgery by healthcare providers at a previous consultation.
Participants responses to the question what is vaginal prolapse? were classified into six categories (Table 9). The categories of causes included: vaginal delivery; heavy lifting; weakness in
muscle/connective tissue; age; obesity; heredity; menopause; insufficient pelvic floor training; previous
gynaecological surgery; delivery of macrosomic infant; and constipation. In all three groups, the
majority of responses regarding description of vaginal prolapse were related to vaginal bulging.
The most cited causes of vaginal prolapse in all three groups were vaginal delivery, heavy lifting,
and weakness in the muscle and connective tissues. The participants in the vaginal prolapse group
also reported other causes more frequently, for example menopause and heredity (p = 0.004 and p
< 0.001 respectively). Up to 15% of the participants reported that not being active in pelvic floor
training was a cause of vaginal prolapse. Women in the reference groups reported dont know
more frequently regarding description and causes of prolapse than the prolapse group (p = 0.004
and p < 0.001 respectively).
Table 9. Examples of participants descriptions of vaginal prolapse.
Category
Vaginal bulging

When vagina cannot stay inside and is falling out


Uterus is falling down
Bowel, urinary bladder or uterus bulge in the vagina

Vaginal discomfort

Something rubs; it feels uncomfortable

Vaginal pressure

Feeling that something presses on vagina


Sense of pressure

Weakness in muscle/
connective tissue

Weakness of vaginal muscle and suspension device


Weakness of the muscle in the vagina

Urinary/bowel symptoms

Having difficulty emptying the bladder and evacuating the bowel


You have to help yourself manually to empty the bowel content
When you have an urinary leakage

Visible

Uterus is falling down and it is visible at the entrance to the vagina


The vaginal wall is falling outside

The sources of information on their own condition differed significantly between the three
groups. The prolapse group gained their information from the Internet, healthcare providers,
and family/ friends to a lower degree than the reference groups (p = 0.008, p < 0.001, and p =
0.007 respectively). However, participants in the incontinence group gained their information
from brochures and public media (the daily press, weekly magazine, and TV/radio) to a higher
degree than the other two groups. Furthermore, participants in the prolapse group reported
significantly fewer sources of information on their own condition than the other two groups
(p < 0.001).
32

R e s u lt s

Comparison of the responses between the participants who answered our questionnaire on
Web (n = 561) and those who responded on paper (n = 79) showed the same pattern regarding
healthcare-seeking behaviour, description of POP, causes of POP, and source of information.
However, the participants in the prolapse group and the incontinence group who used a paper
questionnaire were older and had a lower level of education than the participants in the prolapse
and incontinence groups who answered the WBQ. Furthermore, the participants in the prolapse
group and the incontinence group who used a paper questionnaire had used the Internet less
frequently to obtain information about their own condition than the women in these two groups
who had used the WBQ (data not shown).

33

34

General discussion
The most interesting findings of this thesis were the patient-perceived outcomes after vaginal
hysterectomy, showing that the overactive bladder symptoms (e.g. urge incontinence and urgency)
were improved; however, a proportion of subjects presented with a new onset of urinary symptoms.
Sexual activity increased in 20% of the subjects and symptoms of vaginal heaviness were cured for the
majority of patients after vaginal hysterectomy. Severe perioperative and postoperative complications
occurred in 3% of cases. Furthermore, comparison of short-term follow-up after cystocele repair
surgery in relation to different anaesthesia used did not reveal that there were any disadvantages of
using LA. POP surgery can therefore be performed safely with LA. In-depth interviews with subjects
with POP explored different factors that might act as facilitators or inhibitors in seeking healthcare.
One of the inhibitors to seeking such care was insufficient information about POP in the societal
arena. The hypothesis generated was tested in a further study, and we found that women with POP
had less access to information in brochures and from the public media regarding vaginal prolapse
than women awaiting surgical procedure for incontinence.
EFFECTS OF POP SURGERY ON SYMPTOMS
Few studies have evaluated the effects of vaginal reconstructive surgery on the resolution of
overactive bladder symptoms in women with prolapse (79, 171-173). Retrospective review of
the medical records of women with grade II or higher prolapse and urge incontinence who have
undergone POP surgery has shown that urge incontinence can become resolved after surgery in
63% of subjects (171). Resolution of overactive bladder symptoms has been reported in 5080%
of patients after transvaginal surgery of advanced prolapse and anterior vaginal repair (79, 171173). Weber et al. showed that anterior colporrhaphy could result in resolution of SUI in 73%
of cases (79). New onset of urgency, urge incontinence, and SUI after anterior vaginal repair was
reported in 26%, 14%, and 8% respectively in that study (79). Resolution of urgency and urge
incontinence symptoms in paper I was found to be comparable to the results of earlier studies
(79, 171-173). However, in paper I new onset of urgency, urge incontinence, and SUI was found
in 6%, 3%, and 11% of the patients respectively. In paper II, symptoms of UI were resolved in
43% of subjects who reported this symptom preoperatively. New onset of UI (of any kind) after
cystocele repair surgery in our study was found in 11% of the patients.
It has been debated that a vaginal hysterectomy possibly contributes to the development of
urinary symptoms. In a prospective study, De Tayrac et al. compared vaginal hysterectomy for
menorrhagia with endometrial ablation and found no differences in the incontinence rate (174).
However, Forsgren et al. showed that the risk of SUI was 6 times higher after vaginal hysterectomy
for POP than in women who had not had a hysterectomy (1). The increased risk of SUI was
almost three times higher subsequent to a vaginal hysterectomy for a non-prolapse indication
than in women who had not had a hysterectomy. The occurrence of de novo stress incontinence
after a vaginal hysterectomy for uterine descent has been reported in up to 22% of women (111,
175-176), and the corresponding figure in our study (paper I) was 11%.
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discussion

Urodynamic investigation in patients undergoing prolapse surgery may be valuable in order to


diagnose SUI or occult SUI, resulting in selection of the optimal treatment strategy (76). This
treatment strategy includes either a combination of prolapse and stress incontinence surgery or
prolapse surgery initially and re-evaluation of possible stress incontinence afterwards. In patients
with vaginal prolapse and occult SUI, there are conflicting data about the reduction of SUI
symptoms if prolapse surgery is combined with anti-incontinence surgery (177-178). Liang et
al. showed a reduction of 56% in the symptoms of SUI, while Tayrac et al. showed a reduction
of only 12% if prolapse surgery was combined with stress incontinence surgery. Both studies
showed an increased risk on overactive bladder symptoms after the combination surgery (177178). Against this background, gynaecologists should discuss both treatment options with their
patients, and their advantages and disadvantages.
In paper II, cystocele repair surgery provided relief of symptoms related to vaginal protrusion
in 63% of the subjects. However, 23% reported subjective symptoms of persistence of a vaginal
bulge one year after surgery. Repair of cystocele is one of the most challenging aspects of pelvic
reconstructive surgery, due to high recurrence rates related to the surgery (79). There have been
few studies on subjective outcome after cystocele surgery. Anterior colporrhaphy for repair of
cystocele has shown a variety of objective success rates (4196%) (179).
There are conflicting data concerning the effects of pelvic floor surgery on sexual function.
Studies have demonstrated that sexual life can be improved (95, 180), remain unaltered, or become
worse (181-182). In our study (paper I), vaginal hysterectomy for prolapse had a positive effect
on sexual activity, and dyspareunia was not common in the study sample. In an earlier study,
mild to severe dyspareunia was reported in up to 20% of women after a vaginal hysterectomy
for uterovaginal prolapse (112). However, in that study 90% of the subjects were subject to
posterior colporrhaphy and perineorrhaphy, which might explain the higher rate of dyspareunia.
Other studies have shown that sexual function is improved after vaginal hysterectomy for uterine
prolapse, due to resolution of the prolapse symptoms (180, 183).
In a randomised trial, improvement in all urogenital domain scores (UI, overactive bladder,
prolapse) and quality of life (mobility, physical function, social functioning, emotional functioning, and embarrassment) was found one year after a vaginal hysterectomy because of vaginal
prolapse (184).
COMPLICATIONS AFTER VAGINAL HYSTERECTOMY
Severe complications that resulted in re-admission or reoperation were reported in 3% of the
case (paper I). Vault haematoma/abscess constituted 1% (9/941) of all complications. This is
in accordance with results from recently published studies (185-186). In paper I, the majority
of severe complications were attributed to infections. Younger women presented more severe
complications such as vaginal vault abscess, probably due to the fact that bacterial vaginosis was
more common in this group of women, making them more susceptible to postoperative infections (187). The overall complication rate reported by patients was 30%; however, surgeons
assessed the patient-reported complications to be a medical complication in only 14% of cases.
This reflects the fact that patients and professionals have different frames of reference in their assessment of complications. Some complications reported by patients were normal and expected
conditions after surgery.
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discussion

VAGINAL HYSTERECTOMY FOR TREATMENT OF UTERINE DESCENT


Vaginal hysterectomy combined with apical suspension is usually considered to be the first choice
for treatment of uterine descent (109). In a review article comparing complications and anatomical
outcomes after vaginal hysterectomy with those after other transvaginal uterus-preserving methods
(the Manchester procedure or sacrospinous hysteropexy), vaginal hysterectomy was found to have
higher morbidity (blood loss, infection) than the Manchester procedure (186, 188-189). When
comparing vaginal hysterectomy with sacrospinous hysteropexy, the morbidity associated with
vaginal hysterectomy is longer operating time, longer recovery time, and more blood loss (190192). After adjusting for age and BMI, there was a threefold higher risk of urge incontinence and
overactive bladder symptoms after vaginal hysterectomy than after sacrospinous hysteropexy (191).
Uterus-preserving procedures are equally effective with regard to anatomical apical cure and recurrent prolapse surgery (including apical or any prolapse) compared to vaginal hysterectomy (186).
However, a retrospective study has shown that vaginal hysterectomy and uterus-preserving
abdominal sacrocolpopexy have similar results with respect to morbidity of the surgical procedure
and risk of recurrence of vaginal prolapse (193). A randomised, controlled trial has shown that
vaginal hysterectomy is superior to uterus-preserving abdominal sacrocolpopexy with respect
to postoperative urogenital function and reoperation rate (184). The same author reported in
an RCT study that vaginal hysterectomy is associated with less pain, better mobility, and better
quality of life during the first 6 weeks of recovery compared to the uterus-preserving abdominal
approach (194).
A large Swedish cohort study revealed that vaginal hysterectomy in women with POP may
be associated with a 5 times higher risk of subsequent POP surgery than in women who do not
have a hysterectomy (1). Paper I presented some short-term results from the patients point of
view. The anatomical cure rate was not presented.
There is no definitive golden standard procedure for treatment of uterovaginal prolapse. Thus,
the surgeons skill in different surgical techniques, patients preference, age, and comorbidity all
play an important roll in the choice of operation for uterine prolapse.
IMPACT OF ANAESTHESIA ON PROLAPSE SURGERY
In choosing an anaesthetic technique, issues related to safety and efficiency must be considered
(124). In paper II, short-term outcomes after cystocele surgery in relation to different anaesthetic
methods did not reveal any disadvantage of surgery using LA. Advantages of LA (Paper II) were
a short hospital stay and fast recovery time. However, length of hospital stay and the speed of
the recovery period are related to many factors, e.g. age, preoperative morbidity, distance to the
hospital, and the doctors opinion and attitude regarding the convalescence period (195-196).
Fast-track surgery using a multi-modal rehabilitation care program with a well-defined scheme
for the convalescence period has been shown to hasten postoperative recovery, reducing the hospital stay period and morbidity (197-200). Fast-track surgery has been used for colon surgery,
laparoscopic surgery, and vaginal prolapse surgery (199, 201).
The choice of anaesthesia at surgery appears to be related to the individual patient and surgeons preference/experience and also to the prevailing tradition at hospitals. Earlier studies have
investigated the feasibility of using LA in prolapse surgery and showed a high degree of patient
satisfaction (2, 120). However, the results from these studies were based on surgeons with a great
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discussion

deal of experience of POP under LA. The results of paper II show that cystocele repair surgery can
be performed safely with LA and that patient satisfaction is not related to anaesthetic method.
Long-term follow-up in terms of recurrence rate is of interest concerning the use of LA in
POP surgery. However, most studies investigating LA in prolapse surgery have not had a long
follow-up period (2-3, 120, 122-123).
QUALITATIVE RESEARCH AS A COMPLEMENTARY TOOL
While qualitative and quantitative research may investigate similar topics, each will address different kinds of questions (156). Qualitative research is suitable for gaining an in-depth understanding
of a phenomenon. Qualitative research may explain why the result of quantitative research based
on a large group of women may be irrelevant to subgroups (152).
Qualitative research complements quantitative research in urogynaecology
(155)
. For example, a vital stage in questionnaire research is validation of individual questions by performing
interviews to check the meaning of words to be used.
Srikrishna et al. emphasise the importance of qualitative research when exploring experiences
and expectations of women with POP (202)

. While a disease-specific QOL questionnaire allows us to assess patients inconvenience, these questionnaires may lack the sensitivity to explore
individual experiences. In paper III, women tended to minimise the importance of symptoms
and this is consistent with findings in earlier studies (134, 203). In addition, in our study (paper
III) womens self-image was affected, their social activities were negatively influenced, and insufficient knowledge about vaginal prolapse was expressed. The results were consistent with those
of another qualitative study (204).
Most previous research regarding sexuality in women with POP has focused on sexual function, including frequency and pain during intercourse. Qualitative studies can address another
aspect of sexuality in women suffering from POP and how they experience their body and how
this condition may influence their sexual life. In paper III, some informants expressed that they
did not feel sexually attractive to their partners. This observation is consistent with findings in
another qualitative study of women with POP of stage II or more (205). However, in contrast to
our study, participants who were single in that study was not interested in dating/finding a sexual
partner; a group of women who were particularly affected by POP in our study.
The findings in the qualitative study (paper III) generated a hypotheses consisted of insufficient
level of knowledge about POP at an individual level, as well as insufficient information on POP
in the public arena. Thus, the findings from paper III were tested further in a quantitative study
(paper IV) to estimate the extent of the problem among women undergoing surgery for POP.
HEALTHCARE-SEEKING BEHAVIOUR
Many factors, e.g. age or effect on QOL, are known to affect care seeking for UI (206-208) but
little is known about POP healthcare-seeking. Some studies have suggested that only 1020%
of women with POP seek healthcare for their problems (209). Burigo et al. showed that older
adults with UI did not report the condition to their doctor due to being ashamed, but the severity of incontinence and physical disability were the strongest predictors of healthcare-seeking
behaviour (207). Marital status, gender, income, employment status, and educational level were
not associated with seeking treatment for UI in that study.
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discussion

In our study (paper IV), 25% of women with POP initially had tried conservative treatment but
gradually realised that this treatment was not sufficient. In accordance with the previously performed study in paper III and studies investigating healthcare-seeking behaviour in incontinent
women (135, 207-208), it was increasing symptoms and interference with physical and sexual
activity that made women seek healthcare. Furthermore, in line with other studies (134, 207,
210-211), one third of the subjects in the incontinence group in paper IV reported they were
embarrassed to talk about their condition, and the same proportion of subjects were unaware of
the fact that the condition could be treated.
Sexual life was affected in one out of three women with POP who sought healthcare in our
study (paper IV). This observation is in line with earlier results
(72, 84)
. It is notable that personal economic loss and employment-related issues were not common reasons for not seeking
healthcare in our study.
DESCRIPTION AND CAUSES OF POP REPORTED BY SUBJECTS
In paper IV, POP was described by subjects with and without symptoms of vaginal prolapse.
The most prevalent description of POP among the participants was vaginal bulging. The most
common reported causes of POP were vaginal delivery, heavy lifting, and weakness in muscle/
connective tissue. Participants descriptions of POP in paper IV were almost in accordance with
the existing descriptions in the scientific literature (9, 62, 64, 75, 212). Previous studies have
demonstrated that the presence of a vaginal bulge is the symptom most strongly correlated with
the presence of advanced POP (35, 67). On average, participants in the prolapse group reported
a higher number of causes related to vaginal prolapse, and they also reported other causes of
prolapse, e.g. menopause and heredity, more frequently; thus, they seemed to be more oriented
to this condition.
Not being active in pelvic floor exercise was reported by the participants as cause of prolapse.
Avulsion of the levator ani muscle during vaginal childbirth is associated with development of
POP (27), and furthermore, neuromuscular injury that occurs during vaginal birth can contribute
to UI and POP (28-29). Pelvic floor training is commonly used as the first step in the treatment
of urinary and fecal incontinence (96-97). However, the effects of pelvic floor training in the
prevention of POP are uncertain (98).
SOURCES OF INFORMATION ON SPECIFIC CONDITIONS
Sources of information on the subjects own condition differed significantly between the participants in paper IV. Besides the information that participants received from the healthcare providers, they also consulted family and friends and searched actively on the Internet for information.
Subjects with vaginal prolapse had less access to information through brochures and public media
than women in the incontinence group. When comparing the prolapse group with the reference groups, we found that they received information from healthcare providers less frequently.
In addition, subjects in the prolapse group reported significantly fewer sources of information
than the reference groups. We can conclude that there appeared to be a lack of information on
prolapse in the public arena. This is in line with the findings in our previous study in paper III.
The participants in the incontinence group and the prolapse group, who answered our questionnaire on paper, used the Internet less frequently to obtain information. This might correspond
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discussion

to the fact that they were older and had a lower level of education. Interestingly, subjects in the
incontinence group had more access to information brochures and public media than the subjects
in the other two groups. In general, the mass media have helped to publicise UI, particularly by
advertising anti-cholinergic medication and sanitary pads. Similar publicity does not exist for
POP. In Sweden, subjects suffering from incontinence have access to the incontinence association through a web link (213), where they can gain information. This channel of information is
lacking for subjects with POP. This observation is in accordance with the findings in paper III.
METHODOLOGICAL CONSIDERATIONS
In this section, some methodological considerations are discussed, firstly regarding the use of
secondary data (as in the case of the Gynop-register). Thereafter, each paper is discussed in terms
of the strengths and limitations of both primary and secondary data. Factors that affect the value
of research on secondary data such as healthcare register data are: the accuracy and degree of
completeness of the data registered, completeness of registration of the individuals, the size of
the data source, and the possibility of linkage to other data sources (214).
The accuracy and degree of completeness of the data registered

The accuracy of the data registered refers to the idea that a questionnaire measures what it is meant
to measure and to do it in a reliable way, i.e. validity and precision (214). The questionnaires
used for data collection in the Gynop-register were validated previously and a number of studies
from the register have been published in peer-reviewed journals (200, 215-217). Generally, a
low response rate poses a threat to the validity of quantitative research (218). The strengths of
papers III and IV were the high response rate (more than 90%) and the high completeness of
the data in the register.
Completeness of registration of the individuals

As previously mentioned, the mean proportion of patients undergoing gynaecological surgery and
included in the register was 96% of eligible patients, in accordance with an inspection visit in 15
clinics. Furthermore, we made a comparison of different clinical variables and characteristics of
subjects undergoing POP surgery in these 15 clinics, and the remaining 28 clinics that were not
inspected regarding inclusion of the patients in the register. All subjects undergoing POP surgery
from 2009 to 2010 were included in the comparison (Table 10). No statistically significant differences were found. We can therefore conclude that our selected group of patients in the studies
included in this thesis did not diverge from those in the clinics that had been inspected by the
Board of the Gynop-register.
One way of estimating the degree of completeness of records in the Gynop-register is to
compare the data source with other independent reference sources where the whole of the target
group is registered (214). We compared the number of patients admitted in hospitals for POP
surgery and registered in the Gynop-register during 2009 with the number of patients undergoing
POP in the inpatient care, based on the Swedish Inpatient Register. We found that the overall
number of patients registered in the Gynop-register was in line with the number of patients in
the Swedish Inpatient Register.

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discussion

Table 10. Characteristics of women who underwent prolapse surgery during 2009, at clinics
being inspected versus not being inspected by the Board of the Gynop-register.
Variables

Group A (n = 1609)

Group B (n = 2057)

P-value

Age

63.8 11.1

63.6 11.2

NS

BMI

26.3 3.86

26.2 3.79

NS

2.56 1.1

2.58 1.1

NS

Number of pregnancy

3.05 1.51

3.07 1.5

NS

Employed

630 (39)

750 (36)

NS

Smoker

156 (10)

203 (10)

NS

Co-morbidity
Diabetes mellitus
Hypertension
Cardio-vascular disease
Pulmonary disease

80 (5)
621 (39)
176 (11)
279 (17)

123 (6)
673 (33)
197 (10)
350 (17)

NS
0.01*
NS
NS

Parity

All values are expressed as mean standard deviation or number and (%).
Group A; women who underwent surgery in 15 clinics which has been inspected regarding inclusion of patients. Group B; women who underwent surgery in 28 clinics which has not been inspected.
*Applying Bonferroni, nonsignificant

The size of the data source

The size of the data source, i.e. the number of people and the number of variables registered, may
have an impact in the results
(214)
. In a large data source, even small associations will give statistically significant results (214). Relating the size of the data source to the clinical relevance of any
differences is therefore more important in such cases than simply looking at the p-values (214).
In statistics, a method used to address the problem with multiple comparisons is the Bonferroni
correction, which was used in the quantitative studies included in the thesis.
Possibility of linkage to other data sources

In Scandinavia, each person is assigned a unique personal registration number at birth, allowing
linkage between several data systems. The Gynop-register is cross-linked to the Cause of Death
Register, the register of the total population, and the Inpatient register.
Strengths and limitations

The study samples in papers III and IV consisted of subjects who underwent surgery for POP
and who were registered in the Gynop-register. Referring to Table 4, the Gynop-register has
good coverage of clinics performing POP surgery in Sweden, and the register covers 51% of the
patients undergoing POP surgery in the inpatient care. We have no reason to question the idea
that women undergoing surgery for POP and who are registered in the Gynop-register would
differ from women undergoing surgery for POP and who are not registered in the Gynop-register.
Inclusion of the subjects in the register was done by a secretary or an operations planner who did
not make any medical judgement of the patients. With this strategy, every eligible patient had
the same opportunity to be included in the register and in the studies, and thus we consider that
there was probably no selection bias regarding inclusion of patients in the register.

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discussion

Papers I and II

In paper I, we used data from the hysterectomy section of the Gynop-register on subjects who
underwent vaginal hysterectomy for the indication POP. This section of the register has the most
extended coverage concerning gynaecological surgery. The limitation of paper I was that there was
no information included in this section of the register on the stage of the prolapse or on the type
of vaginal apical suspension performed during surgery. The decision to perform vaginal hysterectomy (with the indication prolapse) was made by individual gynaecologists. There is evidence
that vaginal apical correction using mesh has a higher rate of complications requiring reoperation
than the traditional vaginal surgeries and sacrocolpopexy (219). Thus, we could not discriminate
whether some of the complications were related to the mode of the apical suspension procedure.
In paper II, there were missing data on registration of current use of the anaesthesia method.
In order to avoid selection bias for registration of the anaesthesia method in paper II, we chose a
cut off limit of 60% for registration of anaesthesia for including clinics in the study. All the clinics (n = 4) that had more than 40% missing data concerning registration of anaesthetic method
used for surgery were excluded. With this approach, we excluded 175 operations in which the
anaesthesia method was registered in only 55 subjects. The cut-off point of 40% for excluding
clinics was chosen because it was the largest gap seen between clinics regarding missing information for registration of anaesthetic method. Among eligible women in the study, the information
about the type of anaesthesia method used at surgery was not registered for 200 subjects. We
therefore analysed the characteristics of the subjects included in the study (n = 1,364) and the
subjects who were excluded because of missing information on use of anaesthesia (n = 200), and
we found no statistically significant differences. Thus, we might be able to conclude that the
anaesthetic method was not registered by chance.
In paper I, the non-response analyses were performed by manually retrieving data from the
medical records of those who had not responded to the follow-up questionnaire (n = 36). No
severe complications could be identified among the non-respondents. Because of the high response
rate, the issue of non-response bias was not of importance in paper II.
An advantage of a retrospective study design is that all the events under the study period have
already occurred. The conclusions can therefore be drawn more rapidly and they can scarcely be
influenced by the hypothesis (151). The other strength of these studies was that they reflected
the routine healthcare setting and were focused on patient-perceived results postoperatively.
Despite the involvement of different surgeons with different surgical techniques and surgical
skills, the complication rate was low.
Paper III

In this paper, we restricted our study to subjects who did not have a history of recurrence of vaginal
prolapse because we postulated that recall of earlier symptoms might affect their narratives in the
current interview. We used qualitative content analysis because it offers a straightforward method
of analysing textual data and provides some specific norms and guidelines for data analysis (161).
The aim in a qualitative research interview is to explore the interviewees own framework of
meanings and to avoid predetermined structures as far as possible (220). In qualitative research,
there is a possibility that the concepts that emerge during the study may be very different from
those that have been assumed at the beginning of the research, and the researcher should remain
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discussion

open to this possibility (220). The strength of our study design was purposive sampling of the
informants and the emergent design of the study, which enhanced the quality of the data collected.
In qualitative research, interview data are constructed jointly by the interviewer (investigator) and the interviewee. There is therefore a risk that the pre-understanding of the researcher
will influence the analysis and the interpretation of the findings. In order to reduce the risk of
bias and challenge the authors own pre-understanding, the findings were discussed within the
research group, who had heterogeneous experiences. The findings were also presented at seminars,
leading to new input from those outside the research group. The research group consisted of one
urogynaecologist, one gynaecologist, a midwife, and an obstetrician. The last two researchers had
substantial experience of qualitative and quantitative research.
An important aspect of credibility in this paper was to present the data and the process of
analysis (161). Trustworthiness was further enhanced in this study by independent categorisation
during the process of analysis, as proposed by Burnard (221). Another aspect of the credibility
of research findings in qualitative research is seeking agreement between co-researchers and
informants (161). However, no respondent confirmation (member checks) was conducted in
paper III, since the findings were synthesised, decontextualised, and abstracted from individual
characteristics. Hence, the informants might not recognise their own contributions to the study.
To establish dependability, an open dialogue between researchers was created and interpretation
of the data was discussed. The researchers judgments about the new data obtained during the
study period and similarities and differences of content were consistent over time. Confirmability
of this paper was established by leaving a decision trail, i.e. discussing theoretical, methodological, and analytical processes (222)

. To further visualise the interpretation of the findings, quotations from the text were used to illustrate the experiences of the subjects. Regarding the issue of
transferability, the experiences described by the subjects in paper III may be transferred to other
women in similar settings.
One limitation of this paper was one interview conducted by the first author who had an
ongoing patient-doctor relationship with the informant, who was the youngest of the subjects.
There is an assumption that an interviewee who is already a patient may wish to please the doctor by giving the responses she thinks the doctor wants. However, the informant gave one of the
most comprehensive narratives in the study material.
Paper IV

The strength of this study was that the questionnaire used was developed exclusively for this
study, based on the findings from paper III.
The overall response rate was 95% and the response rate in different questions was high
(8499%). The response options in the questionnaire were based on the interview study in paper
III and the pre-existing options covered 9199% of the answers produced. Belief in getting better
with time, having other medical conditions that needed treatment first, being afraid of surgery, and
adapting/accepting the condition were cited by 8% as reasons for not seeking healthcare earlier and
they were not captured in the available options.
Subjects who answered a web-based questionnaire were included in the study. This study
design might raise concern related to the representativeness of the study sample in relation to the
source population. However, we compared participants responses gained from the web-based
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discussion

questionnaire to responses from a small group of participants who answered our questionnaire
on paper (n = 79). The same pattern in the responses concerning healthcare-seeking behaviour,
and description and causes of POP was found. However, the number of participants who answered the questionnaire on paper was relatively low, which affected the statistical power, so we
chose not to present these results in paper IV. In addition, we compared the characteristics of
the participants with two groups of non-participants answering a preoperative questionnaire
on paper to determine whether the study sample was representative. The first reference group
of non-participants were subjects whose e-mail addresses were unknown (n = 426). The second
reference group of non-participants were subjects who did not have an e-mail address (n = 997).
All non-participants were planned for POP surgery, hysterectomy, or anti-incontinence surgery
during the same period as the study period. Significant differences were only found between
participants included in study IV and non-participants who did not have an e-mail address,
concerning characteristics such as age, hypertension, diabetes, current use of HRT, and menopause (Table 11). However, after performing a multiple logistic regression analysis for each of
the dependent variables (mentioned above), we found that age was the only significant variable
explaining the differences in the prevalence of hypertension, diabetes, menopause, and current
use of HRT between the participants in study IV and non-participants not having e-mail address.
Thus, we may conclude that our results are most probably representative of the population of
subjects planned for gynaecological surgery because of POP, bleeding disorder, or incontinence.
Table 11. Characteristics of the participants responding a Web questionnaire compared with
two reference groups of non-participants responding a paper questionnaire.
Variable

A (n = 561)

B (n = 426)

C (n = 997)

P-value

Age

52 10.7

51.5 10.5

62.2 13

< 0.001

BMI

27 11.2

26.4 4.7

27.2 4.8

NS

3 1.5

3.1 1.7

3 1.8

NS

2.5 2.4

2.4 1.08

2.5 1.29

NS

63 (11)

66 (15)

93 (9)

0.01*

Smoker

66 (12)

67 (16)

123 (12)

NS

Hypertension

123 (22)

88 (21)

343 (34)

< 0.001

Pregnancy
Parity
Previous caesarean section

Diabetes

18 (3)

15 (3.5)

79 (8)

< 0.001

Current HRT

124 (22)

101 (24)

298 (30)

< 0.001

Menopause

234 (42)

160 (38)

592 (59)

< 0.001

All values are expressed as mean standard deviation or number and (%)
Note: A= Participants responding a web questionnaire; B= non-participants with unknown e-mail address,
responded paper questionnaire; C= non-participants who did not have an e-mail address, responded paper
questionnaire; HRT, hormone replacement therapy
Group A was compared with group B and C.
*Applying Bonferroni, nonsignificant

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discussion

There is an assumption that patients are prone to give what they consider the correct answer
to a researcher. We cannot therefore be sure whether participants description of vaginal prolapse is based on their own understanding or whether it is based on the information they have
gained by consulting others or by searching for information on the Internet. This is of particular concern regarding the participants in the reference groups. Participants in the prolapse
group were requested to report their sources of information on their condition; however, the
source of information regarding description of prolapse among the reference groups was not
highlighted. It is possible that we might have captured other aspects of the subjects perception
of vaginal prolapse by expanding the questionnaire to include more questions and/or other
question formats, e.g. multiple-choice questions.
In general, when performing prospective studies, following subjects over a long period of time
can be problematic due to loss to follow-up (150). Eligible participants in this study were included
prior to the surgery and the likelihood of discontinuing the participation was not an issue.

45

46

Conclusion
Papers I and II provided results of POP surgery. With patients in focus, we also explored their
experiences of vaginal prolapse and its effect on their daily lives in a qualitative study (paper III)
in order to search for new, unexplored information. In that study, patients expressed that they
had to search actively to find information on vaginal prolapse, and they experienced insufficient
information on vaginal prolapse in the public domain. Some women could not relate their symptoms of prolapse. Based on the results from study III, we developed a questionnaire in which
perception of vaginal prolapse, source of information on their own condition, and the causes for
seeking healthcare, were requested (paper IV). Patients with a planned surgery for POP, UI, or
bleeding disorder (resulting in hysterectomy) were included in the study. The latter two groups
were used as reference groups in the study.
In paper I, the results of vaginal hysterectomy for the indication prolapse in a routine healthcare setting showed few complications. Subjective outcomes concerning symptoms of urgency
and urge incontinence were resolved in over 50% of the subjects, and local symptoms of vaginal
heaviness and pressure were cured in over 80%. However, the number of subjects who complained
of SUI was doubled and the prevalence of new onset of SUI was 11%. Surgery had a positive
effect on sexual activity.
In paper II, we found that cystocele surgery using local anaesthesia was comparable to surgery with other anaesthetic methods. Surgery can be performed safely under LA if there are no
contraindications or specific patient preferences.
In paper III, one of the obstacles in seeking healthcare was lack of information about POP and
lack of confirmation by the physician at a previous consultation. The main facilitators related to
seeking healthcare were the feeling of being sexually unattractive and impaired physical ability
due to vaginal prolapse. By providing easily accessible information on POP, the possibility of
subjects gaining knowledge about their condition can be improved and they may then overcome
obstacles to seeking healthcare. Healthcare professionals have a significant role to play in facilitating the process by confirming and informing women about the condition, and counselling them
on available treatment options.
In paper IV, we found that women with a planned surgery for prolapse, urinary incontinence,
or bleeding disorder (resulting in hysterectomy) generally appeared to have relevant information
on POP. However, one out of five women in the prolapse group did not know that her symptoms were related to vaginal prolapse and it was found that they had less access to information
brochures than subjects in the incontinence group. We can therefore conclude that the general
population might benefit from information about POP and awareness of related symptoms to
improve healthcare-seeking behaviour in patients with the condition.

47

48

Clinical implications
POP is a common condition in elderly women who might have poor health, and use of invasive
anaesthetic methods might therefore be dangerous (223-224). Since repair of cystocele under
local anaesthetic is comparable to surgery using other forms of anaesthesia, it is of benefit to
patients to perform surgery in LA if there is no contraindication or no specific patient preference.
However, local anaesthesia might even be considered in POP surgery of younger women because
it allows quicker return to daily activities.
POP has a negative effect on womens quality of life. Women participating in our study
revealed that there is a lack of information on POP in the social arena, and some women could
not consider their symptoms as being associated with vaginal prolapse. Healthcare providers
have a significant roll in providing patients with adequate information on their condition and
on the available treatment options. Furthermore, due to the complex relationship between POP
and the existing symptoms, it is important to discuss the effect of surgery on symptoms, and
the possibility of occurrence of new symptoms, so that patients are provided with sufficient
information preoperatively.

49

50

Future research
Suggestions for future research in this field:
Randomised controlled trials comparing long-term outcomes after POP surgery related
to different anaesthetic methods.
Postoperative in-depth interviews with women for whom sexuality has been affected by
vaginal prolapse, in order to explore the effect of surgery on sexual life.
Investigation of the most common surgical method for treatment of uterovaginal prolapse
in Sweden.
Multi-centre studies investigating womens knowledge about prolapse.
Investigation of patient involvement in decision making before POP surgery, and also
the quality of the information that patients receive prior to surgical treatment.
Studies investigating the influence of different changes of lifestyle on prevention of POP.
Investigation of the role of improvement of pelvic-floor muscle strength in prevention
of POP.

51

52

Acknowledgements
I would like to express my sincere gratitude and deepest appreciation to all those who have helped
and supported me throughout my thesis. In particular I would like to thank:
Mats Lfgren, my principal tutor and supervisor, for your warmth and generous support, for
always taking time and guiding me through the investigation. Thank you for your endless support and introducing me to the Gynop database.
Ingrid Mogren, associate professor, my co-tutor, for encouraging me in this investigation and
always being supportive, for your excellent scientific writing. Thank you for your invaluable
contribution to this thesis and always giving constructive comments on my manuscript.
Ewa Rolfsman, my third tutor, for your enthusiasm and engagement, for your skilful and
insightful comments on construction of the questionnaire. Thank you enormously for your
support and constructive comments in this thesis.
Margareta Persson, my co-author, for your contagious passion in qualitative study and your
valuable comment in the paper.
All the women who have contributed to these studies.
Hkan Lindkvist, Department of Mathematics and Mathematical Statistics, Ume University,
for your skilful statistical advice.
Ann Lalos, head of Obstetrics and Gynecology, Ume University, for your support, and for
believing in me.
Torbjrn Bckstrm, my examiner and former head of Obstetrics and Gynecology, Ume University, for your engagement, enthusiasm and sharing your scientific experience.
Per ke Holmgren, Director of clinical division of Obstetrics and Gynecology, for your financial
support and make it possible for me to have time for research.
Jan Wall and Erik Bjurulf, my colleagues for your patience with me during my work with thesis.
I appreciate your support enormously.
Birgitta Renstrm, Carina Jonsson, and Birgit Ericsson for your data support and administrative help and encouragement.
Urban Janlert, professor at the department of Epidemiology and Global Health Ume University,
sa Hrnsten, senior lecture at the department of Nursing Ume University, and Jan Henrik
Stjerndahl, associate professor at the department of Obstetrics and Gynecology, Sahlgrenska
University Hospital, Gothenburg for your valuable comments on my pre-disputation.
Sofia Pemer at Medicine library for your help with EndNote.
To all my collegues for enjoyable teamwork.
My parents and my sister, for being happy for my happiness, for your love and support.
53

A c k n ow l e d g e m e n ts

My daughter, Abrak, for encouraging me and making me proud and happy, thank you for giving
me energy. You are the most precious person in my life.
Thomas, my husband and my love for your support in all aspects of my life, for being understanding and generously sharing your great knowledge with me.
The studies in this thesis were supported by grants from Kempe Foundation, Ume, Sweden;
The Swedish Association of Local Authorities and Regions; the County Council of Vsterbotten
Sweden; the County Council Research and Development Vsterbotten.

54

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66

1: Markera de utbildningar som du har avslutat.


 Grundskola (eller folkskola, realskola)
 Folkhgskoleutbildning
 Gymnasieutbildning
 Hgskole- eller universitetsutbildning
2: Har du haft symtomen du skt fr i mer n ett r?
Om nej g till nsta sida, frga 3.

 Ja  Nej

2a: Antal r
2b: Varfr skte du inte tidigare? Markera ett eller flera svarsalternativ
 Mina besvr har ftt st tillbaka pga andra familjemedlemmars behov.
 Ansg att den ekonomiska frlusten vid sjukskrivning var fr stor.
 Har skt tidigare men behandlingen som gavs r otillrcklig.
 Bedmde sjlv att besvren inte var s allvarliga.
 Har inte ansett mig kunna ta ledigt frn arbetet.
 Har skt tidigare men ftt rdet att avvakta.
 Obehagligt att bli gynekologiskt underskt.
 Visste inte att besvren kunde behandlas.
 Visste inte att besvren var framfall. (besvarades enbart av prolapspatienter)
 Knns genant att prata om problemet.
 Hade planerat att fda fler barn.
 Annat: ..
2c: Vad r anledningen till att du sker nu? Markera ett eller flera svarsalternativ
 Provat annan behandling men den ger inte tillrcklig effekt.
 Blivit erbjuden operation tidigare men valde att avvakta.
 kad pverkan p mitt sociala liv (umgnge, fritid, sport etc).
 kad pverkan p mitt arbetsliv (frmgan att skta arbetet).
 Blev uppmanad av annan person att ska.
 kad pverkan p mitt sex- och samliv.
 Skte egentligen av annan orsak.
 Tilltagande symtom
 Annat: ..

3: Misstnkte du att dina symtom och besvr berodde p framfall innan lkare konstaterade att
du hade framfall?
 Ja
 Nej (besvarades enbart av prolapspatienter)
Om nej, vad trodde du att dina besvr berodde p? Markera ett eller flera svarsalternativ
 Urinvgsinfektion/ urinvgsbesvr
 Effekt av tunga lyft eller tungt arbete
 Tidigare graviditeter
 ldersfrndringar
 Frstoppning
 Tumr
 Annat
4: r det bestmt att du skall opereras?  Ja  Nej
Om nej, hoppa till nsta sida, frga 5.
4a: Upplever du att du var delaktig i operationsbeslutet?  Ja  Nej
Om nej, hade du nskat delaktighet i beslutet?
 Ja  Nej
4b: Har du och din lkare diskuterat operationens effekter p dina symtom?
Om nej, hade du nskat sdan diskussion?
 Ja  Nej
4c: Har lkare informerat dig om operationens eventuella effekt p;
Att tmma tarmen?
 Ja  Nej
Om nej, hade du nskat sdan information?
 Ja  Nej
Att hlla urinen?
Om nej, hade du nskat sdan information?

 Ja  Nej
 Ja  Nej

Att tmma urinblsan?


Om nej, hade du nskat sdan information?

 Ja  Nej
 Ja  Nej

Att ha samlag?
Om nej, hade du nskat sdan information?

 Ja  Nej
 Ja  Nej

5: Fick du under lkarbesket mjlighet att stlla de frgor du nskade?


 Ja

 Nej

 Ja  Nej

6: Har du under det senaste ret tagit del av ngon information om


framfall / urininkontinens / menstruations-/bldningsrubbning via:

Slkt, vnner eller bekanta

 Ja  Nej

Besk inom sjukvrden

 Ja  Nej

Informationsbroschyrer

 Ja  Nej

Dags-/ kvllspress

 Ja  Nej

Veckopress / mnadsmagasin  Ja  Nej


Bcker

 Ja  Nej

Radio / TV

 Ja  Nej

Internet

 Ja  Nej

Annan informationsklla,

 Ja  Nej

Om ja vilken? : ..
7: Framfall r ngot som mnga kvinnor fr, men det r inte alltid ltt fr kvinnan att sjlv veta att det
rr sig om ett framfall.
7a: Beskriv vad du tror att framfall r ?: ...

7b: Vad tror du orsakar framfall?: ..


Datum fr enktens besvarande..

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