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Chirurgie of fysiotherapie voor stressincontinentie: wat is de behandeling van eerste keuze bij vrouwen? (Surgery or physiotherapy for urinary stress incontinence: what is the preferred treatment in women?) [Dutch]
Labrie J, Berghmans LCM, Fischer K, Lagro-Janssen ALM, van der Vaart CH
Nederlands Tijdschrift voor Geneeskunde 2014 Mar;158(12):A7233
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To compare midurethral sling surgery and pelvic floor physiotherapy as initial treatment in women with moderate to severe urinary stress incontinence. DESIGN: Multicentre randomised trial. METHOD: The study population was made up of women aged 35 to 80 years with moderate to severe stress incontinence. They received surgical treatment or pelvic floor physiotherapy, having been stratified according to incontinence severity. Crossover between groups was allowed during the follow-up period. Improvement at 12 months follow-up measured with the Patient Global Impression of Improvement score was the primary outcome measure (Dutch Trial Register number: NTR1248). RESULTS: We randomised 230 women to the sling surgery group and 230 to pelvic floor physiotherapy group. A total of 49% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. An 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: 18.1 to 34.5). A post hoc per-protocol analysis showed that women who underwent additional surgery after physiotherapy had similar outcomes to women initially assigned to surgery. CONCLUSION: The symptoms of women with moderate to severe stress incontinence were improved more with midurethral sling surgery than with pelvic floor exercises at 1 year.

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