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Type: Journal article
Title: Surgery versus physiotherapy for stress urinary incontinence
Author: Labrie, J.
Berghmans, B.
Fischer, K.
Milani, F.
van der Wijk, I.
Smalbraak, D.
Vollebregt, A.
Schellart, R.
Graziosi, G.
van der Ploeg, J.
Brouns, J.
Tiersma, E.
Groenendijk, A.
Scholten, P.
Mol, B.
Blokhuis, E.
Adriaanse, A.
Schram, A.
Roovers, J.
Lagro-Janssen, A.
et al.
Citation: New England Journal of Medicine, 2013; 369(12):1124-1133
Publisher: Massachusetts Medical Society
Issue Date: 2013
ISSN: 0028-4793
Statement of
Julien Labrie, Bary L.C.M. Berghmans, Kathelijn Fischer, Alfredo L. Milani, Ileana van der Wijk, Dina J.C. Smalbraak, Astrid Vollebregt, René P. Schellart, Giuseppe C.M. Graziosi, J. Marinus van der Ploeg, Joseph F.G.M. Brouns, E. Stella M. Tiersma, Annette G. Groenendijk, Piet Scholten, Ben Willem Mol, Elisabeth E. Blokhuis, Albert H. Adriaanse, Aaltje Schram, Jan-Paul W.R. Roovers, Antoine L.M. Lagro-Janssen and Carl H. van der Vaart
Abstract: Background: Physiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy. Methods: We performed a multicenter, randomized trial to compare physiotherapy and midurethral- sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months. Results: We randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those 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 improvement and subjective and objective cure at 1 year. (Funded by ZonMw, the Netherlands Organization for Health Research and Development; Dutch Trial Register number, NTR1248.)
Keywords: Humans
Urinary Incontinence, Stress
Intraoperative Complications
Postoperative Complications
Treatment Outcome
Middle Aged
Patient Satisfaction
Physical Therapy Modalities
Suburethral Slings
Intention to Treat Analysis
Rights: Copyright © 2013 Massachusetts Medical Society
DOI: 10.1056/NEJMoa1210627
Appears in Collections:Aurora harvest 2
Obstetrics and Gynaecology publications

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