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|Group-based versus individual pelvic floor muscle training to treat urinary incontinence in older women: a randomized clinical trial [with consumer summary]|
|Dumoulin C, Morin M, Danieli C, Cacciari L, Mayrand MH, Tousignant M, Abrahamowicz M, Urinary Incontinence and Aging Study Group|
|JAMA Internal Medicine 2020 Aug 3:Epub ahead of print|
|8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; 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*|
IMPORTANCE: Urinary incontinence is one of the most prevalent health concerns experienced by older women (aged >= 60 years). Individual pelvic floor muscle training (PFMT) is the recommended first-line treatment for stress or mixed urinary incontinence in women, but human and financial resources limit its delivery. Whether group-based PFMT performs as well as individual PFMT in this population remains unclear. OBJECTIVE: To assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women. DESIGN, SETTING, AND PARTICIPANTS: The group rehabilitation or individual physiotherapy (GROUP) study is a single-blind, randomized, noninferiority trial conducted in 2 Canadian research centers, from July 1, 2012, to June 2, 2018. A total of 362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled. Interventions: After an individual session conducted to learn how to contract pelvic floor muscles, participants completed 12-week PFMT as part of a group of 8 women (n = 178) or in individual sessions (n = 184). MAIN OUTCOMES AND MEASURES: The primary outcome measure was the percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline. Secondary outcomes included lower urinary tract-related signs, symptoms, and quality of life immediately following treatment and at 1 year. Per-protocol analysis was used. RESULTS: Among 362 women who were randomized (mean (SD) age 67.9 (5.8) years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis. Median percentage reduction in urinary incontinence episodes was 70% (95% CI 44% to 89%) in individual PFMT compared with 74% (95% CI 46% to 86%) in group-based PFMT. The upper boundary of the 95% CI for the difference in the percentage reduction in urinary incontinence episodes at 1 year was lower than the prespecified margin for noninferiority of 10% (difference 4%; 95% CI -10% to 7%; p = 0.58), confirming noninferiority. Individual PFMT and group-based PFMT had similar effectiveness for all secondary outcomes at 1 year. Adverse events were minor and uncommon. CONCLUSIONS AND RELEVANCE: Results of the GROUP study suggest that group-based PFMT is not inferior to the recommended individual PFMT for the treatment of stress and mixed urinary incontinence in older women. Widespread use in clinical practice may help increase continence-care affordability and treatment availability. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02039830.