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.
To assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women.
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.
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).
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.
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%-89%) in individual PFMT compared with 74% (95% CI, 46%-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 = .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.
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.
ClinicalTrials.gov Identifier: NCT02039830.
JAMA internal medicine. 2020 Aug 03 [Epub ahead of print]
Chantale Dumoulin, Mélanie Morin, Coraline Danieli, Licia Cacciari, Marie-Hélène Mayrand, Michel Tousignant, Michal Abrahamowicz, Urinary Incontinence and Aging Study Group
School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada., School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada., Research Institute of the McGill University Health Center, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, Canada., Department of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal, Research Center of the Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada., Department of Epidemiology, Biostatistics, and Occupational Health, McGill University and Research Institute of the McGill University Health Center, Montreal, Québec, Canada.