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original article
A bs t r ac t
Background
From the University Medical Center Utrecht Physiotherapy involving pelvic-floor muscle training is advocated as first-line treat-
(J.L., K.F., C.H.V.) and Diakonessenhuis ment for stress urinary incontinence; midurethral-sling surgery is generally recom-
(P.S.), Utrecht; University Medical Center
Maastricht, Maastricht (B.L.C.M.B.); mended when physiotherapy is unsuccessful. Data are lacking from randomized
Reinier de Graaf Gasthuis, Delft (A.L.M.); trials comparing these two options as initial therapy.
Groene Hart Ziekenhuis, Gouda (I.W.);
Amphia Ziekenhuis, Breda (D.J.C.S.); Methods
Spaarne Ziekenhuis, Hoofddorp (A.V.); We performed a multicenter, randomized trial to compare physiotherapy and midure-
Kennemer Gasthuis, Haarlem (R.P.S.); An-
tonius Ziekenhuis, Nieuwegein (G.C.M.G.); thral-sling surgery in women with stress urinary incontinence. Crossover between
Martini Ziekenhuis (J.M.P.) and University groups was allowed. The primary outcome was subjective improvement, measured
Medical Center Groningen (A.S.), Gron- by means of the Patient Global Impression of Improvement at 12 months.
ingen; Zaans Medisch Centrum, Zaan-
dam (J.F.G.M.B.); Vrije Universiteit Me- Results
disch Centrum (E.S.M.T.), Onze Lieve
Vrouwe Gasthuis (A.G.G.), and Academic
We randomly assigned 230 women to the surgery group and 230 women to the
Medical Center (B.W.M., J.-P.W.R.R.), physiotherapy group. A total of 49.0% of women in the physiotherapy group and
Amsterdam; Hofpoort Ziekenhuis, Woer 11.2% of women in the surgery group crossed over to the alternative treatment.
den (E.E.B.); Medisch Centrum Alkmaar,
Alkmaar (A.H.A.); and University Medical
In an intention-to-treat analysis, subjective improvement was reported by 90.8% of
Center Nijmegen, Nijmegen (A.L.M.L.-J.) women in the surgery group and 64.4% of women in the physiotherapy group (abso-
all in the Netherlands. Address reprint lute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5).
requests to Dr. Labrie at University Medical
Centre Utrecht, Heidelberglaan 100, P.O.
The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physio
Box 85500, Room F05.121, Utrecht, the therapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3);
Netherlands, or at j.labrie@umcutrecht.nl. rates of objective cure were 76.5% and 58.8%, respectively (absolute difference,
N Engl J Med 2013;369:1124-33. 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed
DOI: 10.1056/NEJMoa1210627 that women who crossed over to the surgery group had outcomes similar to those
Copyright 2013 Massachusetts Medical Society.
of women initially assigned to surgery and that both these groups had outcomes
superior to those of women who did not cross over to surgery.
Conclusions
For women with stress urinary incontinence, initial midurethral-sling surgery, as
compared with initial physiotherapy, results in higher rates of subjective improve-
ment and subjective and objective cure at 1 year. (Funded by ZonMw, the Nether-
lands Organization for Health Research and Development; Dutch Trial Register
number, NTR1248.)
S
tress urinary incontinence is a com- tinence] and also on physical exertion, sneezing,
mon health problem among women that or coughing), stress incontinence was classified
negatively affects quality of life.1-3 The In- as predominant if there were more episodes of
ternational Consultation on Incontinence de- stress than urge incontinence, as reported on the
fines stress urinary incontinence as an involun- validated Dutch version of the Urogenital Distress
tary loss of urine on physical exertion, sneezing, or Inventory.13 Women included in the study either had
coughing.4 Pelvic-floor muscle training (physio- not received treatment or had undergone physio-
therapy) is generally regarded as first-line man- therapy more than 6 months before randomiza-
agement for the condition.5 However, physiother- tion. The diagnosis of stress urinary incontinence
apy is associated with broad variation in the rates was based on a demonstration of leakage of urine
of subjective success (53 to 97%) and objective on straining or coughing at a bladder volume of
success (5 to 49%), and more severe symptoms at least 300 ml. Urodynamic testing to confirm
are associated with worse outcomes.6,7 After 3 to the diagnosis was not mandatory for eligibility.15
15 years, 25 to 50% of women initially treated Women who had undergone previous inconti-
with physiotherapy have proceeded to surgery.7-9 nence surgery or who had concomitant pelvic-
Midurethral-sling surgery is a minimally invasive organ prolapse of stage 2 or higher (according to
surgical technique for the treatment of stress uri- the Pelvic Organ Prolapse Quantification system)
nary incontinence,10 with subjective cure rates were excluded.4
between 75% and 94% and objective cure rates The ethics committee of the Utrecht Medical
between 57% and 92%.1,11,12 The procedure is re- Center and the institutional review boards at the
garded as effective, with minimal complications.11 individual sites approved the study protocol
The difference in the reported frequencies of (available at NEJM.org). The last author assumes
a successful outcome between surgery and phys- responsibility for the completeness and accuracy
iotherapy raises the question of whether all of the data and analyses and for the fidelity of
women with moderate-to-severe stress-predomi- the study to the protocol. The trial was initiated
nant urinary incontinence should initially be and performed without the support or involve-
treated with physiotherapy or should immedi- ment of manufacturers of midurethral slings.
ately undergo surgery as initial treatment. Midure- After written informed consent was obtained,
thral-sling surgery and physiotherapy have not research nurses on site performed computerized
been directly compared. We therefore conducted randomization on a central server. An indepen-
a multicenter, pragmatic, randomized trial to dent data manager designed the randomization
compare initial midurethral-sling surgery with table. Women were assigned in a 1:1 ratio to the
initial physiotherapy in women with moderate-to- surgery group or the physiotherapy group, with
severe stress urinary incontinence, using stan- blocks of four per center, stratified according to
dardized outcome measures at 12 months. the severity of incontinence (moderate or severe).
The treatment assignments were not concealed.
Me thods Surgical procedures were performed by 49 gyne-
cologists and urologists. Before participating in
Study Design this trial, each surgeon had performed a mini-
We performed our randomized trial at 4 univer- mum of 20 procedures. Both retropubic and trans
sity medical centers and 19 general hospitals obturator midurethral-sling surgical techniques
(24% of Dutch hospitals). The study protocol and were allowed.10,16
inclusion and exclusion criteria have been pub- Physiotherapy was performed by 83 (17%) of
lished previously.13 In brief, eligible women were the 478 certified pelvic physiotherapists in the
35 to 80 years of age and had been referred to an Netherlands. Pelvic-floor muscle training for
outpatient gynecology or urology clinic after pre- stress urinary incontinence was performed ac-
senting with stress urinary incontinence classi- cording to the Dutch guidelines.17 Women were
fied as moderate or severe according to the sever- educated about the function of the pelvic-floor
ity index developed by Sandvik et al.14 (see Table muscles, bladder function, and how to perform
S1 in the Supplementary Appendix, available with a correct pelvic-floor muscle contraction. They
the full text of this article at NEJM.org). In women were also taught to perform a short muscle con-
presenting with mixed incontinence (involuntary traction before an increase in intraabdominal
loss of urine associated with urgency [urge incon- pressure, such as that associated with sneezing.18
215 Were included in the intention-to-treat 202 Were included in the intention-to-treat
analysis with imputed data analysis with imputed data
NewcombeWilson method for interval estima- All statistical analyses were performed with
tion, and Fishers exact test was used for calcu- the use of SPSS Statistics for Windows, version
lating the significance level.27 17.0 (SPSS).
Students t-test was used to compare continu-
ous data between groups. Changes in UDI and R e sult s
IIQ domain scores over time were analyzed with
the use of a paired-samples Students t-test. To Study Population
facilitate interpretation of changes in UDI and During the period from March 2008 through
IIQ scores, effect sizes were calculated with the May 2010, a total of 656 women with stress uri-
use of Cohens D test. An effect size of 0.3 or nary incontinence or mixed urinary incontinence
less was considered small, more than 0.3 to 0.8 in which stress incontinence was predominant
moderate, and more than 0.8 large.28 were asked to participate in the study, of whom
A post hoc per-protocol analysis of outcomes 460 gave written informed consent. These wom-
among women who underwent physiotherapy en were randomly assigned to the surgery group
only, women who underwent surgery after physio- (230) or the physiotherapy group (230) (Fig. 1).
therapy, and women who underwent initial sur- Analyses were performed for 215 women
gery was performed with the use of one-way assigned to the surgery group and 202 women as
analysis of variance and paired t-tests with Holms signed to the physiotherapy group; at 12 months,
Bonferroni correction for multiple comparisons. outcome data were available for 196 (91.2%)
and 174 (86.1%) of these women, respectively additional physiotherapy after surgery; these
(P=0.11). In the physiotherapy group, 99 women women had symptoms related to pelvic-floor
(49.0%) crossed over to the surgery group, after muscle hyperactivity, such as obstructive micturi-
a mean (SD) time of 31.712.7 weeks. tion, and underwent training to relax the pelvic-
The frequency of crossover to the surgery floor muscles.
group was similar among women who had un-
dergone specialized physiotherapy before enroll- Intention-to-Treat Analysis
ment and women who had not received previous Baseline characteristics and UDI and IIQ domain
treatment (47.4% [18 of 38] vs. 49.4% [81 of 164], scores were similar in the two groups (Table 1).
P=0.86). Twenty-two women (11.2%) received Primary and secondary outcomes according to
* Plusminus values are means SD. No significant between-group differences were observed for any characteristic.
PGI-S denotes Patient Global Impression of Severity.
The body-mass index is the weight in kilograms divided by the square of the height in meters. Data were available for
212 women in the surgery group and 193 women in the physiotherapy group.
Data were available for 202 women in the surgery group and 177 women in the physiotherapy group.
Domain scores on the Incontinence Impact Questionnaire (IIQ) and the Urogenital Distress Inventory (UDI) scores
range from 0 to 100, with higher scores indicating more distress caused by urogenital symptoms (UDI) or a more
negative effect on health-related quality of life (IIQ).24,25 Data were available for 212 women in the surgery group and
199women in the physiotherapy group.
the assigned treatment group, for both original Subjective cure and objective cure of stress uri-
and imputed data, are presented in Table 2. The nary incontinence were significantly more fre-
PGI-I and PGI-S responses for all follow-up as- quent in the surgery group than in the physio-
sessments, including the assessment at 18 months, therapy group (objective cure, P=0.001; subjective
are shown in Table S2 in the Supplementary Ap- cure, P<0.001). Treatment effects are shown in
pendix. At 12 months, a significantly higher pro- Table 2.
portion of women assigned to the surgery group Both treatment groups had significant im-
reported improvement, as compared with wom- provement in UDI and IIQ domain scores, as
en assigned to the physiotherapy group; the dif- compared with baseline values (Table 2). Im-
ference between the groups was 26.4 percentage provements in the UDI scores for incontinence
points (95% confidence interval [CI], 18.1 to 34.5; and overactive bladder were significantly greater
P<0.001) for the original data and 26.5 percent- in the surgery group than in the physiotherapy
age points (95% CI, 18.5 to 34.2; P<0.001) when group (P<0.001 and P=0.02, respectively, for the
the imputed data were included. Of the 99 women original data), but with only moderate effect sizes;
who crossed over from physiotherapy to surgery, the effect sizes were 0.50 (95% CI, 1.6 to 2.6)
90 (90.9%) reported no improvement on the last for incontinence and 0.36 (95% CI, 1.0 to 1.7)
PGI-I assessment before surgery was performed. for overactive bladder. In the comparison of IIQ
Table 2. Primary and Secondary Outcomes in the Surgery and Physiotherapy Groups at 12 Months.*
Physiotherapy
Surgery Group Group
Outcome (N=196) (N=174) Original Data Imputed Data
Treatment Effect (95% CI)
percentage points
PGI-I: improvement no./total no. (%) 177/195 (90.8) 112/174 (64.4) 26.4 (18.134.5) 26.5 (18.534.2)
PGI-S: no symptoms no./total no. (%) 167/195 (85.6) 114/174 (65.5) 20.1 (11.428.6) 19.7 (11.427.8)
Subjective cure no./total no. (%) 167/196 (85.2) 93/174 (53.4) 31.8 (22.640.3) 29.2 (20.537.4)
Objective cure no./total no. (%) 140/183 (76.5) 94/160 (58.8) 17.8 (7.927.3) 15.5 (6.424.2)
P Value
Change in UDI domain score
Urinary incontinence 37.320.9** 26.920.6** <0.001 <0.001
Overactive bladder 15.520.5** 10.619.5** 0.02 0.01
Obstructive micturition 7.922.4** 3.820.1 0.06 0.06
Discomfort or pain 7.413.8** 5.411.6** 0.15 0.18
Genital prolapse 1.811.6 1.910.8 0.97 0.77
Change in IIQ domain score
Physical functioning 13.217.2 10.317.0 0.11 0.12
Mobility 24.619.9 17.521.8 0.001 0.004
Emotional health 15.115.7 11.818.1 0.07 0.24
Social functioning 8.516.6 9.719.3 0.54 0.55
Embarrassment 26.623.2 19.324.5 0.004 0.006
* Plusminus values are means SD. PGI-I denotes Patient Global Impression of Improvement.
P0.001 for all four outcomes in the analyses of both the original data and the imputed data.
Subjective cure was measured with the UDI question, Do you experience urine leakage related to physical activity,
coughing, or sneezing?
Objective cure was defined as a negative provocative cough stress test.
P values are for comparisons between the physiotherapy group and the surgery group.
Data were available for 193 women in the surgery group and 171 women in the physiotherapy group.
** P<0.001 for the change in the domain score over time in the analyses of both the original data and the imputed data.
P<0.001 for changes in all domain scores over time for both groups in the analyses of both the original data and the
imputed data.
Discussion
domain scores between groups, improvements
in mobility and embarrassment scores were sig- In this Dutch nationwide, multicenter trial, we
nificantly greater in the surgery group than in compared strategies of initial surgery and initial
the physiotherapy group (P=0.001 and P=0.004, physiotherapy, with an option to cross over to sur-
respectively), but again with only moderate effect gery, in the treatment of women with moderate-
sizes; effect sizes were 0.34 (95% CI, 1.8 to 2.5) to-severe stress-predominant urinary incontinence.
for mobility and 0.31 (95% CI, 2.1 to 2.7) for Women randomly assigned to undergo initial
embarrassment. surgery were significantly more likely to have im-
provement at 12 months than were those as-
Adverse Events signed to receive initial physiotherapy. Surgery
Table 3 summarizes adverse events in both groups. also resulted in greater improvement than did
A total of 65 adverse events occurred in 41 (9.8%) physiotherapy on all secondary end points. The
of 417 women; all adverse events were related to benefits of surgery persisted in analyses involv-
surgery. Intraoperative bladder perforation and ing multiple imputation of missing data. In a
vaginal epithelial perforations were successfully subsequent per-protocol analysis, women in the
treated during surgery without further clinical physiotherapy group who crossed over to the sur-
implications. Three women had a recorded blood gery group had outcomes that were similar to
loss of 500 ml or more. One woman needed re- those among women who underwent initial sur-
operation to loosen the synthetic sling because gery, whereas women who underwent only physio-
of persistent voiding problems, and six reopera- therapy had significantly less favorable outcomes.
tions were performed for tape exposure. Our study has some limitations. Selection bias
may have occurred. Women with a preference for
Post Hoc Per-Protocol Analysis surgery may have been more likely to participate
Table 4 shows the results of the post hoc per- in the study, because they otherwise would have
protocol analysis comparing women who under- received initial physiotherapy according to Dutch
went only physiotherapy (103), those who under- guidelines. In addition, women who had under-
went surgery after physiotherapy (99), and those gone physiotherapy more than 6 months before
who underwent initial surgery (215). At 12 months, entering the trial were allowed to participate,
the proportion of women who reported improve- although they represented only one fifth of the
ment was lower among women who underwent study population; a negative experience with prior
physiotherapy may have negatively affected their (24% of Dutch university and general hospitals),
adherence to the study regimen and the number as well as many gynecologists, urologists, and
of sessions they attended, which could have re- certified pelvic physiotherapists (17% of certi-
sulted in a lower efficacy of physiotherapy.29 fied Dutch pelvic physiotherapists). Because we
However, this possibility is not supported by our allowed both the transobturator and retropubic
data; in the physiotherapy group, prior physio- techniques for the placement of polypropylene
therapy was similarly frequent among those who tape, the range of typical clinical practice was
crossed over to surgery and those who did not. represented in the surgery group. Complications
The high crossover rate (49.0%) among women of surgery were limited and were consistent with
assigned to the physiotherapy group complicates those seen in prior studies of sling surgery.11,12
the interpretation of results, because we used a We used patient-reported outcomes because cli-
modified intention-to-treat analysis. To address nicians assessments have often been shown to
this problem, we performed a post hoc per-pro- underestimate the degree of symptom-related
tocol analysis, which showed a favorable effect distress perceived by women.30,31 In our study,
of additional surgery in the physiotherapy group. both subjective and objective outcomes in the sur-
Strengths of our study include our random- gery group were superior to those in the physio-
ized design and inclusion of a variety of centers therapy group.
The frequency of improvement in the surgery pelvic-floor muscles during the clinical provoca-
group (90.8%) was slightly higher than that re- tive cough test yet still had stress urinary incon-
ported in the literature (68 to 87%).20-23,32-34 tinence in everyday life in response to unexpected
Heterogeneity in the study design, patient popu- events.
lation, interventions, and outcome measures may In summary, the results of our trial show that
account for this difference.11 The improvement women with moderate-to-severe stress urinary
rate (64.4%) we observed in the physiotherapy incontinence have significantly better subjective
group, which included women who crossed over and objective outcomes at 12 months after sur-
to surgery, was higher than the rates in two gery than after physiotherapy. Our findings sug-
other physiotherapy studies, which did not allow gest that women with this condition should be
crossover (33% and 43%).35,36 Our high cross- counseled regarding both pelvic-floor muscle
over rate is the most likely explanation; the fre- training and midurethral-sling surgery as initial
quency of improvement among women who did treatment options. Information on expected out-
not cross over to surgery (31.7%) is similar to comes with both interventions, as well as on the
the frequencies in the other studies. potential, albeit infrequent, complications of sur-
In contrast to the findings in another prior gery, will allow for individualized decision mak-
study,5 the rate of subjective cure among women ing by each woman and her health care provider.
in the physiotherapy group in our study was
lower than the rate of objective cure (15.9% vs. Supported by a grant from ZonMw, the Netherlands Organiza-
tion for Health Research and Development (80-82310-98-08203).
44.0%). It is possible that women who under- Disclosure forms provided by the authors are available with
went physiotherapy were able to control their the full text of this article at NEJM.org.
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