What was the design of the GROUP Trial?

The GROUP trial is a non-inferiority trial comparing group-based and individual pelvic floor muscle physiotherapy for the treatment of stress and mixed urinary incontinence (UI) in older women.

What results did the trial find?

In women who can contract their pelvic floor muscles, the GROUP trial robustly showed that group-based pelvic floor physiotherapy is not inferior to an individual approach in reducing UI episodes at one year post-randomisation for women aged 60 and over, with a percentage reduction in UI episodes in the individual pelvic floor muscle training intervention of 70 per cent compared to 74 per cent in the group-based pelvic floor muscle training intervention (difference –4%, 95%CI –10 to 7%, P=0.58; Dumoulin et al 2020).

Group-based pelvic floor muscle physiotherapy has similar high effectiveness when it comes to lower urinary tract-related signs and symptoms and a similar impact on quality of life, self-efficacy, impression of improvement and satisfaction.

It has very good adherence, with a low number of minor and reversible adverse events.

How did you go about comparing the cost-effectiveness of the two ways to deliver pelvic floor muscle training in your latest economic analysis?

Chantale Dumoulin (above) published the GROUP Trial, comparing individual with group-based pelvic floor muscle training. Dr Licia Cacciari (top) was the lead author on an economic evaluation of the trial.

We estimated pelvic floor muscle physiotherapy costs when provided individually or in groups, both from a participant and from a provider perspective, over one year.

Effectiveness was based on the reduction in leakage episodes and on quality-adjusted life years.

The cost-effectiveness assumption was based on the incremental cost-effectiveness ratios and net monetary benefit calculated for each of the effectiveness outcomes and perspectives.

How did the cost-effectiveness of individual and group pelvic floor muscle training compare?

Group-based pelvic floor muscle physiotherapy was over 60 per cent less costly and as clinically effective as the standard individual pelvic floor muscle physiotherapy.

In both study arms, over 70 per cent of the participants reached a clinically meaningful reduction in the number of leakage episodes.

Health-related quality of life also reached a clinically meaningful improvement that was comparable for both arms.

How did you assess the acceptability of the group format to the women?

We assessed acceptability through the concepts of loss to follow-up and adherence to treatment.

Loss to follow-up until the end of the intervention was low (approximately seven per cent), similar between arms and unrelated to treatment allocation.

Adherence to treatment sessions and exercises was high and similar between groups (over 95 per cent and 85 per cent respectively), indicating the acceptability of both interventions.

No important adverse event was reported.

This could help women who are paying for their own pelvic floor muscle training sessions by making the intervention more affordable, right?

We strongly believe that group pelvic floor physiotherapy can be considered a more affordable way of promoting access to care and encouraging women to pursue and adhere to treatment.

Considering incontinence prevalence in ageing women, demographic projections, human resources and health system constraints, the results of this non-inferiority randomised controlled trial are relevant to healthcare professionals who care for women with urinary incontinence, the women themselves, clinical decision-makers and administrative stakeholders.

The ability to deliver effective treatment more efficiently (eight women versus one woman with a physiotherapist, both for 12 one-hour weekly treatments) will have implications for the organisation and administration of continence care services.

Ultimately, the results may influence the accessibility of conservative management (pelvic floor muscle training) and the use of more invasive interventions such as medication and surgery in older women with UI.

>> Licia Cacciari has a bachelor’s degree in physiotherapy and a doctorate in rehabilitation sciences from the University of São Paulo (2007 and 2017), with a main research focus on the assessment and treatment of pelvic floor muscle function.

>> Chantale Dumoulin is a Professor at the School of Rehabilitation, University of Montreal. She is also a published researcher, specialising in pelvic floor dysfunction, with the research centre of the Institut universitaire de gériatrie de Montréal and more recently with the research centre of the University of Montreal Health Centre.

Reference

Dumoulin C, Morin M, Danielli C, Cacciari L, Mayrand M, Tousignant M, Abrahamovick M. (2020) Group-based versus individual pelvic floor muscle training to treat urinary incontinence in older women. JAMA internal medicine, Aug; 180(10): 1284-1293.