Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial

Chantale Dumoulin, Mélanie Morin, Marie-Hélène Mayrand, Michel Tousignant, Michal Abrahamowicz, Chantale Dumoulin, Mélanie Morin, Marie-Hélène Mayrand, Michel Tousignant, Michal Abrahamowicz

Abstract

Background: Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women-20-25% with severe symptoms. Clinical practice guidelines recommend individualized pelvic floor muscle training (PFMT) as a first-line treatment for stress or mixed UI in women, although lack of human and financial resources limits delivery of this first-line treatment. Preliminary data suggest that group-based treatments may provide the answer. To date, no adequately powered trials have evaluated the effectiveness or cost-effectiveness of group compared to individual PFMT for UI in older women. Given demographic projections, high prevalence of UI in older women, costly barriers, and group PFMT promising results, there is a clear need to rigorously compare the short- and long-term effectiveness and cost-effectiveness of group vs individual PFMT.

Methods/design: The study is designed as a non-inferiority randomized controlled trial, conducted in two facilities (Montreal and Sherbrooke) in the Canadian province of Quebec. Participants include 364 ambulatory, community-dwelling women, aged 60 years and older, with stress or mixed UI. Randomly assigned participants will follow a 12-week PFMT, either in one-on-one sessions or as part of a group, under the supervision of a physiotherapist. Blinded assessments at baseline, immediately post intervention, and at one year will include the seven-day bladder diary, the 24-h pad test, symptoms and quality of life questionnaires, adherence and self-efficacy questionnaire, pelvic floor muscle function, and cost assessments. Primary analysis will test our main hypothesis that group-based treatment is not inferior to individualized treatment with respect to the primary outcome: relative (%) reduction in the number of leakages.

Discussion: Should this study find that a group-based approach is not less effective than individual PFMT, and more cost-effective, this trial will impact positively continence-care accessibility and warrant a change in clinical practice.

Trial registration: ClinicalTrials.gov, NCT02039830 . Registered on 12 December 2013; Study protocol version 2; 21 November 2013.

Keywords: Elderly women; Pelvic floor muscle training; Urinary incontinence.

Conflict of interest statement

Ethics approval and consent to participate

This study has been evaluated and approved by the respective ethics committees at each of the five recruitment sites: the Research Ethics Committee of Institut Universitaire de Gériatrie de Montréal (CER IUGM 12-13- 002), the Centre Hospitalier de l’Université de Montréal (CE 12.347), the CLSC Lucille Teasdale & the CSSS Jeanne Mance (CSSSJM-2014-07-04), and the Centre Hospitalier de l’université de Sherbrooke (#12-170-M5).

The consent form is mailed out to the participant after the telephone eligibility evaluation. Informed consent for each participant is obtained during the onsite eligibility evaluation by the evaluator. The participant has time to consider and ask questions to the evaluator before giving consent.

There was no safety monitoring committee for this trial. None were required because of the low risk level of the provided intervention. However, participant safety is through the steering committee (composed of the trial’s investigators) or monitored independently through the local ethics committees.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments

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