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DOI: 10.1111/j.1471-0528.2008.01742.

Urogynaecology

www.blackwellpublishing.com/bjog

The long-term effectiveness of antenatal pelvic


floor muscle training: eight-year follow up of
a randomised controlled trial
WI Agur,a P Steggles,a M Waterfield,b RM Freemana
a Urogynaecology Research Unit, Derriford Hospital, Plymouth, UK b The Peninsula Medical School, Tamar Science Park, Research Way,
Plymouth, UK
Correspondence: Dr WI Agur, Urogynaecology Research Unit, Derriford Hospital, Plymouth, PL6 8DH, UK. Email wagur@doctors.org.uk

Accepted 10 March 2008.

Objective To determine the long-term effectiveness of antenatal

pelvic floor muscle training (PFMT) on stress urinary incontinence


(SUI).
Design Eight-year follow up of a randomised controlled trial (RCT).
Setting Acute NHS Teaching Trust.
Population Participants in an RCT of antenatal PFMT 8 years

previously.
Method Participants were asked about the presence of SUI, impact

on quality of life, frequency of performance of PFMT and details


of subsequent deliveries.
Main outcome measure The prevalence of SUI at 8 years.
Results One hundred and sixty-four (71%) of the original 230
women responded. The significant improvement in postnatal SUI
originally shown in the PFMT group compared with controls (19.2
versus 32.7%, P = 0.02) at 3 months was not evident 8 years later

(35.4 versus 38.8%, P = 0.7). On direct questioning, 68.4% of the


study group claimed that they still performed PFMT as taught
during the study, with 38.0% of them performing this twice or
more per week. There was no difference in outcome between those
who performed PFMT twice or more per week compared with
those performing PFMT less frequently. There were no differences
in quality-of-life domains between the study and the control
groups at 8 years.
Conclusion The initially beneficial effect of supervised antenatal

PFMT on SUI did not continue for a long term despite the
majority claiming to still perform PFMT. These findings are in
keeping with those of other studies and raise concerns about the
long-term efficacy of PFMT. Strategies to improve compliance
with PFMT are required.
Keywords Antenatal, muscle training, patient compliance, pelvic

floor, stress urinary incontinence.

Please cite this paper as: Agur W, Steggles P, Waterfield M, Freeman R. The long-term effectiveness of antenatal pelvic floor muscle training: eight-year follow up
of a randomised controlled trial. BJOG 2008;115:985990.

Introduction
Postnatal stress urinary incontinence (SUI) is a common
problem affecting up to 34% of women, 1 while 35%
have faecal incontinence.2 The risk is higher, and incontinence is likely to persist in the long term after onset
during pregnancy. 3,4 Evidence suggests that vaginal delivery can contribute to damage to the pelvic floor through
muscle and fascial injury as well as disrupting the nerve
supply.5,6
Antenatal pelvic floor muscle training (PFMT) has been
shown to reduce the incidence of postnatal SUI in the short
term.79 However, in their 6-year follow-up study of postnatal PFMT, Glazener et al.10 showed a lack of long-term

benefit with three-quarters of women still incontinent 6


years later.
The National Institute of Clinical Excellence (NICE)11 recommends PFMT for all women in a first pregnancy for prevention of SUI based upon data from two randomised
controlled trials (RCTs).8,9 In the study of 268 women9 with
antenatal bladder neck mobility (previously shown to be
a risk factor for developing postnatal SUI12), it was found that
fewer women in the intervention group had urinary incontinence compared with controls (19.2 versus 32.7%, P = 0.02)
3 months after delivery.9 We report in this study an 8-year
follow-up study of these women to assess whether antenatal
PFMT has a durable long-term effect and to determine the
extent of womens compliance with PFMT.

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Agur et al.

their confidence intervals were estimated using log-binominal


generalised linear models.14

Methods
Participants were recruited in 19981999 during their 20week visit to the antenatal clinic of an acute NHS Trust
Teaching Hospital. All were primigravidae with bladder neck
mobility12 on perineal ultrasound.13 Details of methodology,
intervention and the outcome at 3 months following delivery
have previously been described.9 Participants were randomised (by computer-generated pseudorandom numbers) to
either monthly PFMT with supervision by a physiotherapist
or a control group where they received only verbal advice
and/or a leaflet on PFMT from their midwives. No record
of the control groups performance of PFMT was made, for
example Oxford score or perineometry as in the study group.
Eight years later, the participants were contacted by letter
inviting them to take part in this follow-up study. Letters
were followed up by a telephone call to explain the study
objectives and to determine whether or not they wished to
take part. Following informed verbal consent, participants
were asked to give details of their childbirth(s) over the past
8 years, the frequency of performing PFMT and the presence
of SUI in the past 48 weeks. Duration of the phone call
(from P.S.) averaged 10 minutes during which the symptom
questionnaire used in the previous study9 and the Kings
Health Questionnaire were completed. Inclusion criteria
were participation in the initial study, being in good general
health as well as willingness to complete the questionnaire by
telephone.
The prevalence of SUI at 8 years was assessed using the
symptom questionnaire used in the original study.9 A severity
question was used to ascertain whether leakage occurred once
a week, twice or more per week or daily. Participants with no
leakage in the previous 4 weeks were regarded as continent.
The original trial sample size had been calculated as 128 test
subjects and 128 controls (based on the results of the previous
study12) to obtain a 5% two-sided significance level and an
80% power to detect the difference in postpartum urinary
incontinence among participants in the two groups, allowing
for a 25% attrition rate.9
Two members of the research team (P.S. and W.I.A.)
entered the 8-year follow-up data onto database software.
Statistical analysis studied the relationship between subsequent childbirth(s), PFMT performance and urinary symptoms comparing all with the results of the original study
(M.W.).
Nominal categorical data were tested using exact forms of
the chi-square test. For 22 tables with a control (layer) variable, the CochraneMantelHaenszel test was used. Mann
Whitney nonparametric tests were used to compare groups
for measurements on an ordered, categorical scale. P < 0.05
were considered significant. Logistic regression model was
used for multivariate analysis as SUI at 8 years was common
(greater than one-third), and adjusted relative risks (RR) and

986

Results
A total of 164 (71%) of the 230 participants with available
postnatal data from the original study responded 8 years later
(Figure 1). No obvious difference was found between participants who responded at the original study and those who
responded 8 years later regarding age (27.6 versus 28.1 years),
mode of index delivery (caesarean section rates: 14.5 versus
15.2%), body mass index (24.5 versus 24.5) or the presence of
urinary incontinence (25.7 versus 26.2%).
The number of nonresponders was higher from the original
treatment group compared with the original control group
(34.2 versus 22.7%, P = 0.004). Nonresponders were younger
than responders, but there were no other significant differences (Table 1).
The mean age at the time of the original study was 27.6 years
(range: 1647 years). Eight years later, 114 (69.5%) participants
had at least one further delivery, while parity was unchanged
(i.e. para 1) in the remaining 50 (30.5%). More women in the
control group went on to have further deliveries compared
with the treatment group (80.0 versus 58.2%, P = 0.004).
The significant improvements in postnatal urinary incontinence seen in the PFMT group compared with controls at
3 months in the original trial (19.2 versus 32.7%, P = 0.02)
were not evident 8 years later (35.4 versus 38.8%, P = 0.75).
The severity of urinary incontinence showed little difference
between the PFMT and the control groups (Table 2). There
was no difference between the groups on any of the eight
domains of the Kings Health Questionnaire.
There was a small number of spontaneous remissions in the
control group: 12 women who had SUI at 3 months were now
dry at 8 years (14.1%). The majority of those who were continent at 8 years were also dry at 3 months: in the control
group, 56 women were dry at 3 months and 40 of them were
dry at 8 years (71%) and in the study group, 65 were dry at
3 months and 47 of them (72%) were dry at 8 years.
The frequency of performing PFMT was recorded from
direct questioning and graded as frequent (26 per week)
or infrequent (1 per week). In the study group at 8 years,
68.4% reported that they still performed PFMT and 38.0% of
them claimed to be undertaking this twice or more per week.
Although participants were not asked about the nature of
their daily activities or using the pretimed contraction (the
knack15), there was no difference in incontinence rates
between those performing PFMT twice or more per week
and those performing PFMT less frequently.
Table 3 and Figure 2 show the relationship between subsequent deliveries and the presence of SUI in the two groups.
In the PFMT group, 46 women had further pregnancies compared with 68 women in the control group. Only one-third of

2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

Eight-year follow up of antenatal pelvic floor muscle training

Figure 1. Study profile. BMN, bladder neck mobility.

those who had further deliveries had SUI compared with


almost half of those whose parity was unchanged. There
was a trend to less SUI in the PFMT group at 8 years but only
in those who had further pregnancies compared with those
who did not (26 versus 37%, not significant).
When assessing mode of delivery and 8-year outcomes, of
those who had a caesarean section (CS) in the first pregnancy
(either in labour or elective; n=25), 3 (25%) had SUI at 8
years in the control group compared with 2 (15%) in the
study group. Those who did not have CS in first pregnancy

had a slightly higher (but nonsignificant) incidence of SUI at


8 years (41% of women in the control group compared with
39% in PFMT group) (Figure 3).
When instrumental deliveries are assessed (for the index or
subsequent pregnancies), of 16 women in the control group,
25% had SUI at 8 years compared with 31% (13 women) in the
PFMT group (nonsignificant). This might suggest that PFMT
is not protective following instrumental delivery. For noninstrumental deliveries, the figures are 38% for the control group
and 34% for the PFMT group. Figure 3 details the effect of the
mode of index delivery on the current prevalence of SUI.

Table 1. Comparison between responders and nonresponders


regarding demographic data and SUI at 3 months
Table 2. SUI severity 8 years following the index delivery
Responders

Nonresponders

P value

28.0 (5.6)

25.8 (5.8)

0.002

24.5 (4.2)

23.7 (4.0)

0.13

14.9

14.9

0.9

26.2

24.2

0.87

SUI severity
Mean age in
years (SD)
Mean body
mass index (SD)
Caesarean section
rate at index
delivery (%)
Postpartum SUI
at 3 months (%)

Absent
Mild (1 per week)
Moderate (26 per week)
Severe (7 per week)
Total

Intervention Control Significance


(n 5 79), (n 5 85),
n (%)
n (%)
51 (64.6)
10 (12.7)
12 (15.2)
6 (7.6)
28 (35.5)

52 (61.2)
12 (14.1)
15 (17.6)
6 (7.1)
33 (38.8)

NS

NS, not significant.

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Agur et al.

Table 3. Relationship between reporting SUI at 8 years and further


deliveries
Intervention Control Total (%) Significance
(n 5 79) (n 5 85)
Women without subsequent birth(s)
Number
33
17
SUI present (%)
16 (48)
8 (47)
Women with subsequent birth(s)
Number
46
68
SUI present (%)
12 (26)
25 (37)

50 (30.5)
24 (48)

NS

114 (69.5)
37 (32.5)

NS

NS, not significant.

Univariate analysis of the factors that may affect the risk of


SUI at 8 years after their first birth revealed four to be significant or of significance: age, mode of index delivery, whether
there were further deliveries and the presence of SUI at 3month postpartum to the index delivery.
When adjusted for age alone, caesarean section showed
a significant protective effect (RR = 0.42, P = 0.03) compared
with vaginal delivery, as did having further deliveries (RR =
0.65, P = 0.025 compared with no further deliveries). No
interactions were found between these two factors. The strongest association was with SUI at 3-month postpartum (RR =
1.98, P < 0.001). The multivariate analysis failed when we
attempted to adjust this factor for age. Excluding age, the
adjusted RR when the other three factors are modelled together
are shown in Table 4. Only SUI at 3-month postpartum was
a significant risk factor in the multivariate analysis.

Discussion
This is the first long-term follow-up study of the effectiveness
of antenatal PFMT in prevention of SUI; a good response rate
was achieved at 8 years (71% of those who completed the
original trial and 61% of those originally randomised). As
there were more nonresponders in the treatment group, this
has the potential to bias the results. It is also possible that some
nonresponders might have improved with PFMT, and there is
no evidence that they had undergone continence surgery.
While antenatal PFMT has been shown to reduce the incidence
of postnatal SUI in the short term,79 the data suggest that the
improvement was not maintained 8 years later. It should be
noted, however, that the attrition rate of the current study
(39% of those originally randomised) is higher than that used
to calculate the sample size of the original study (25%), which
inevitably reduces the power of this current 8-year follow-up
study. Nevertheless, the results are in keeping with those of
a postnatal PFMT study, which showed that three-quarters of
the women still had urinary incontinence 6 years following the
index delivery.10 It has also been shown that the initially
marked difference in urinary symptoms shown between
women groups 6 months after starting an intensive PFMT
programme is no longer maintained 15 years later.16 The previous evidence suggests that the difference in the number of
participants performing PFMT (at 1 year) had disappeared 6
years later10 and that only 28% of women still perform PFMT
in the long term.16 Our data support these findings.
Possible reasons for loss of benefit might be poor compliance
in the study group (only 38.0% claimed to be training twice or

Figure 2. Effect of subsequent deliveries on prevalence of SUI 8 years following participation in the antenatal PFMT trial.

988

2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

Eight-year follow up of antenatal pelvic floor muscle training

Figure 3. Effect of mode of index delivery 8 years ago on current prevalence of SUI in participants.

more per week) and that women in the control group were doing
regular PFMT, which in some women might have been effective;
the so-called Hawthorne effect of an RCT (also described as
avis effect by B et al.17). It is possible that women in the control
group might have been given verbal advice on PFMT in a subsequent pregnancy, but this is unlikely to have been supervised
training with a physiotherapist or a specialist nurse. It is not
possible to confirm whether the study group who had been
individually taught PFMT 8 years earlier (or the control group)
were still performing PFMT correctly at 8 years. It seems reasonable to assume, however, that the study group should still be
aware of the correct technique compared with controls.
As there is no information on how many participants in the
control group received verbal advice and/or the relevant leaflet 8 years ago, we cannot make a firm conclusion that superTable 4. Adjusted RR for SUI 8 years in a multivariate analysis
Factor

Adjusted RR* (95% CI)

Further deliveries
None
1
One or more
0.72 (0.511.01)
Mode of index delivery
Normal delivery
1
Assisted
0.65 (0.381.14)
Caesarean section
0.49 (0.231.06)
SUI at 3-month postpartum
Absent
1
Present
1.98 (1.392.82)
*Adjusted for all other variables in the model.

P value

0.058

0.131
0.069

,0.001

vised PFMT confers no extra benefit over simply giving verbal


advice/information leaflet. The loss of the favourable outcome of PFMT 8 years later is, in our view, because of lack
of compliance rather than an effect of a certain method of
administering the training. The aim of the current study was
not to compare the outcome of the two methods, and the
results do not appear to confirm or deny the superiority of
either method over the other after 8 years.
The mode of delivery showed no significant difference in
the prevalence of SUI between participants who had instrumental deliveries and those who delivered spontaneously or
by caesarean section. This is in keeping with the findings of
previous studies18,19 where the benefit from caesarean section
was found to be only transient. In one study, caesarean delivery seemed to protect against the development of postnatal
SUI, but 3 months after delivery, the statistically significant
influence of the mode of delivery had disappeared.18
Although the association between SUI and childbirth variables (including instrumental deliveries) was found to be
strong in bivariate analysis in another study, the effects of
these variables were insignificant in multivariate analysis.19
The main determinant of the presence of SUI at 8 years seems
to be the presence of SUI at 3 months, and this is consistent
with the findings of previous studies.10,20
This study presents results of the longest follow up of
a cohort of participants who undertook antenatal PFMT with
a satisfactory 71% response rate and attempts to look at compliance and the effects of subsequent pregnancies.
It lends further support to the view that antenatal bladder
neck mobility is a risk factor for postnatal and longer term
SUI.12 The prevalence of SUI seen in the control group

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Agur et al.

(38.8%; Table 2) is higher than the published prevalence rates


for primiparous women.21
Despite the disappointing long-term results using antenatal
PFMT and those of postnatal PFMT,10 nonetheless, the
former has been recommended by the 3rd International
Consultation on Incontinence (ICI)22 and NICE11 as a form
of prevention of postnatal SUI in primigravidae. Further research into motivation techniques is required to improve
compliance with PFMT (e.g. a national training programme
starting in primary care).

Conclusions
The initially beneficial treatment effect of supervised antenatal
PFMT on SUI did not continue long term. These findings are
in keeping with those of other authors and raise questions
about the long-term efficacy of PFMT in prevention of SUI.
Strategies to improve compliance with PFMT are required.

Details of ethics approval


The procedures of the study received ethics approval from the
regional ethics committee.

Funding
Local NHS Trust. j

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