Gunvor Hilde1, Jette Stær-Jensen, Franziska Siafarikas, Marie Ellström Engh, Kari Bø. 1. Department of Sports Medicine, Norwegian School of Sport Sciences, and the Department of Obstetrics and Gynecology, Akershus University Hospital, Lørenskog, and the Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Abstract
OBJECTIVE: To evaluate whether postpartum pelvic floor muscle training decrease prevalence of any urinary incontinence (UI) in primiparous women with and without UI at inclusion (mixed population) and further to perform stratified analyses on women with and without major levator ani muscle defects. METHODS: A two-armed assessor-blinded randomized controlled trial including primiparous women 6 weeks after vaginal delivery was conducted. Participants were stratified on major levator ani muscle defects, verified by transperineal ultrasonography, and thereafter randomly allocated to training or control. All participants were taught to contract the pelvic floor muscles. The control participants received no further intervention, whereas training participants attended a weekly supervised pelvic floor muscle training class and performed daily home exercise for 16 weeks. Primary outcome was self-reported UI analyzed by relative risk. RESULTS: We included 175 women, 55 with major levator ani muscle defects and 120 without. Prevalence of UI at baseline was 39.1% in the training group (n=87) and 50% among those in the control group (n=88). Fifteen women (8.6%) were lost to follow-up. At 6 months after delivery (postintervention), 34.5% and 38.6% reported UI in the training and control groups, respectively. Relative risk analysis of UI gave a nonsignificant effect size of 0.89 (95% confidence interval [CI] 0.60-1.32). Results were similar for the stratum with and without major levator ani muscle defects, 0.89 (95% CI 0.51-1.56) and 0.90 (95% CI 0.53-1.52), respectively. CONCLUSIONS:Postpartum pelvic floor training did not decrease UI prevalence 6 months after delivery in primiparous women. Stratified analysis on women with and without major levator ani muscle defects showed similar nonsignificant results. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01069484. LEVEL OF EVIDENCE: : I.
RCT Entities:
OBJECTIVE: To evaluate whether postpartum pelvic floor muscle training decrease prevalence of any urinary incontinence (UI) in primiparous women with and without UI at inclusion (mixed population) and further to perform stratified analyses on women with and without major levator ani muscle defects. METHODS: A two-armed assessor-blinded randomized controlled trial including primiparous women 6 weeks after vaginal delivery was conducted. Participants were stratified on major levator ani muscle defects, verified by transperineal ultrasonography, and thereafter randomly allocated to training or control. All participants were taught to contract the pelvic floor muscles. The control participants received no further intervention, whereas training participants attended a weekly supervised pelvic floor muscle training class and performed daily home exercise for 16 weeks. Primary outcome was self-reported UI analyzed by relative risk. RESULTS: We included 175 women, 55 with major levator ani muscle defects and 120 without. Prevalence of UI at baseline was 39.1% in the training group (n=87) and 50% among those in the control group (n=88). Fifteen women (8.6%) were lost to follow-up. At 6 months after delivery (postintervention), 34.5% and 38.6% reported UI in the training and control groups, respectively. Relative risk analysis of UI gave a nonsignificant effect size of 0.89 (95% confidence interval [CI] 0.60-1.32). Results were similar for the stratum with and without major levator ani muscle defects, 0.89 (95% CI 0.51-1.56) and 0.90 (95% CI 0.53-1.52), respectively. CONCLUSIONS: Postpartum pelvic floor training did not decrease UI prevalence 6 months after delivery in primiparous women. Stratified analysis on women with and without major levator ani muscle defects showed similar nonsignificant results. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01069484. LEVEL OF EVIDENCE: : I.
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