In a blog for #MyPTArticleOfTheMonth back in October 2019, Kari Bø highlighted the results of a randomised controlled trial that was presented at the International Continence Society’s annual conference in Gothenburg, Sweden. Chantale Dumoulin led this well-designed, non-inferiority, multicenter randomised controlled trial that compared individual pelvic floor muscle training to group training for older women with stress and mixed urinary incontinence. The trial has now been published in JAMA Internal Medicine, and we summarise the results in this blog.
Urinary incontinence is a common health concern experienced by older women (> 60 years). Individual pelvic floor muscle training is the recommended first-line treatment for stress or mixed urinary incontinence in women, but delivery is limited by human and financial resources. Pelvic floor muscle training delivered to a group of women, rather than individually, could overcome these resource barriers. This trial was designed to address the evidence gap of whether group-based pelvic floor muscle training performs as well as individual training. The primary aim was to determine whether the effectiveness of group-based pelvic floor muscle training was not inferior to individual pelvic floor muscle training in women aged 60 years or older with stress or mixed urinary incontinence.
Community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were recruited though advertising on community notice boards, social media and newspapers as well as in the gynaecology and urology clinics in the two trial centres in Montreal and Sherbrooke, Canada. Participants were stratified by centre and type of incontinence, then a concealed and random process was used to allocate participants to either individual- or group-based training sessions. After an individual session was conducted to learn how to contract their pelvic floor muscles, participants undertook 12 weeks of 1-hour weekly pelvic floor muscle training sessions as part of a group of 8 women or individually. Participants in both groups were instructed to do exercises at home. Treatment was provided by experienced pelvic floor physiotherapists. Neither the participants nor the therapists could be blinded to this complex intervention. The primary outcome was the percentage reduction in urinary incontinence episodes at 1 year post-randomisation, as reported in a 7-day bladder diary and relative to pre-treatment values. The margin for noninferiority was prespecified at 10%. Assessors could not be blinded to the primary outcome, but were blinded for some of the secondary outcomes. Adverse events were monitored. While economic data were collected, these were not reported in this article. A per protocol analysis (including all participants who completed the 1 year assessment) was used.
362 women were enrolled in the trial, with 178 allocated to group training and 184 to individual training. 319 participants (88%) completed the 1 year follow-up. There were no imbalances between the groups at baseline. Participants in both groups attended almost 100% of sessions and 87% completed the prescribed home exercise at least 4 times/week. Median percentage reduction in urinary incontinence episodes was 74% for the group-based pelvic floor muscle training and 70% for individual training. The median between-group difference was -4% in favour of group-based training, with a 95% confidence interval of -10% to 7%. Similar results were produced using an intention-to-treat analysis. Because the upper boundary of the 95% confidence interval was lower than the prespecified margin for noninferiority of 10%, group-based training was not inferior to individual training. No serious adverse events occurred in either group.
Group-based pelvic floor muscle training is not inferior to the recommended individual training for the treatment of stress and mixed urinary incontinence in older women. Widespread use group-based training in clinical practice may help increase continence-care affordability and treatment availability. Kari Bø says: “some advantages of group pelvic floor muscle training are that it is less resource intense than individual training, is motivating for both participants and the physiotherapist, and the training can be combined with health education and many other exercises important for women’s health.”
Dumoulin C, et al. Group-based versus individual pelvic floor muscle training to treat urinary incontinence in older women: a randomized clinical trial. JAMA Intern Med 2020 Aug 3:Epub ahead of print