Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women (GROUP)

Group Physiotherapy Compared to Individual Physiotherapy to Treat Urinary Incontinence in Aging Women: A Randomized Control Trial

The recommended treatment for urinary incontinence (UI) in women is individualised pelvic floor muscle (PFM) training, a costly and resource-intense approach; one Canada is currently unable to meet. This non-inferiority randomized control trial seeks to determine if group-based PFM training is as effective as individualised PFM training for treating UI in women 65 and over, and to establish the cost-effectiveness of both. Demonstrating that group-based treatment is at least as good as individualised one-on-one treatment and more cost-effective would warrant including group-based PFM training as a first-line UI treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence; Urinary Stress Incontinence
• Intervention / Treatment: Behavioral: Group physiotherapy; Behavioral: Individual one-on-one physiotherapy

Detailed Description

The incidence of urinary incontinence (UI) in women increases with age but, unbeknownst to many, it is not a normal part of aging and, in most cases, can be effectively treated. Yet today, the majority of senior women go untreated due to a lack of both human and financial resources. In Canada, there are currently 3 million senior women. Over the next 15 years their numbers are expected to grow significantly, as will the incidence of UI. The number of senior women requiring treatment, let alone the future demand, makes it imperative that more cost-effective treatments be identified. The prevalence of UI in community- dwelling women 65 and over is high - 55% experience stress or urge UI, or even both, and of these, 20 to 25% are classified as having severe symptoms. Not only is UI a serious medical condition but it is also undeniably a social problem, engendering embarrassment and negative self-perceptions. It is associated with reduced social interactions and physical activities, with poor self-rated health, impaired emotional and psychological well-being and impaired sexual relationships. Moreover, it doubles women's risk of being admitted to a nursing home, independent of age or the presence of any other co-morbid conditions. It severely undermines a woman's right to healthy aging. Without doubt, this pervasive and serious condition requires immediate attention. Demographics, the negative impact on older women's functional autonomy and the current unmet treatment needs alone renders improving continence care for older women a priority for the Institute of Aging. This study aims to evaluate if group- based physiotherapy treatment is at least as good as individualized one-on-one physiotherapy treatment for treating urinary incontinence in aging women. The treatment efficacy will be assessed in 364 women (aged 60 years and older) suffering from stress or mixed urinary incontinence and recruited in 4 hospitals and in the community.

• Study Type: Interventional
• Enrollment (Actual): 362
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3W 1W5
      • Laboratoire incontinence et vieillissement CRIUGM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 60 years or older
• suffering from stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) symptoms
• at least 3 urinary incontinence episodes per week x 3 months or more
• ambulatory without the need of assisted device
• understand French or English instruction
• hormonal replacement stable for 6 months

Exclusion Criteria:

• present risk factors known to interfere with the effects of PFM training
• >2 degree Pop-Q
• body mass index >35
• chronic constipation
• have received physiotherapy or surgical treatment within the last year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group physiotherapy; 12 weekly treatment visit + daily home exercise program	Behavioral: Group physiotherapy; Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises
Active Comparator: Individual one-on-one physiotherapy; 12 weekly treatment visit + daily home exercise program	Behavioral: Individual one-on-one physiotherapy; Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of UI episodes	evaluated with a 7-day bladder diary	at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms and degree to which UI-associated symptoms are troubling or bothersome	evaluated using the International Consultation on Incontinence questionnaire on urinary incontinence (ICIQ-UI short form)	at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome	evaluated using the International Consultation on Incontinence questionnaire on nocturia (ICIQ-Nocturia)	at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome	evaluated using the 24h PAD test	at recruitment, 13 weeks after recruitment and 12 months after recruitment.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome	evaluated using the International Consultation on Incontinence Questionnaire - Vaginal Symptoms Module (ICIQ-VS)	at recruitment, 13 weeks after recruitment and 12 months after recruitment.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome	evaluated using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)	at recruitment, 13 weeks after recruitment and 12 months after recruitment.
UI related QOL	evaluated using the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol)	at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
UI related self-efficacy	evaluated using the Geriatric self-efficacy index	at recruitment, 13 weeks after recruitment and 12 months after recruitment
UI related self-efficacy	evaluated using the Broom PFM Self-efficacy scale	13 weeks after recruitment (recollection of what was before recruitment and what is now) and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
Costs related to interventions	evaluated using the modified Dowel-Bryant Incontinence Cost Index	at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
Anthropometric measurements	evaluated using height and weight measurements, which will be combined to report BMI in kg/m^2	at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM function	evaluated combining digital palpation (Oxford scale), vaginal atrophy index and dynamometry	at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM morphology	evaluated using transperineal US	at recruitment, 13 weeks after recruitment and 12 months after recruitment
Patient reported improvement and satisfaction	evaluated using Patient global impression of improvement (PGI-I) and Benefit and willingness	13 weeks after recruitment and 12 months after recruitment
Adherence to intervention and home exercises	evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program	after recruitment (once/week during 12 weeks), 13 weeks after after recruitment, 6 months after recruitment, at 9 months after recruitment, 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
Qualitative interview	evaluated using homemade questionnaire including assiduity to lifestyle modification, changes in general health status, changes in medication, perceived change in UI symptoms, consultation with healthcare professionals for UI, and use of additional treatments for UI.	8 years after recruitement for those who completed the 12-month evaluation

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Investigators: Principal Investigator: Chantal Dumoulin, Ph.D., Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Publications and helpful links

General Publications

• Dumoulin C, Morin M, Mayrand MH, Tousignant M, Abrahamowicz M. Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial. Trials. 2017 Nov 16;18(1):544. doi: 10.1186/s13063-017-2261-4.
• Dumoulin C, Morin M, Danieli C, Cacciari L, Mayrand MH, Tousignant M, Abrahamowicz M; Urinary Incontinence and Aging Study Group. Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2020 Oct 1;180(10):1284-1293. doi: 10.1001/jamainternmed.2020.2993.
• Cacciari LP, Kouakou CR, Poder TG, Vale L, Morin M, Mayrand MH, Tousignant M, Dumoulin C. Group-based pelvic floor muscle training is a more cost-effective approach to treat urinary incontinence in older women: economic analysis of a randomised trial. J Physiother. 2022 Jul;68(3):191-196. doi: 10.1016/j.jphys.2022.06.001. Epub 2022 Jun 23.
• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): June 1, 2018
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimated): January 20, 2014

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: rehabilitation; aging; physiotherapy; female; pelvic floor
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Incontinence, Stress; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: CRC01:GROUP; CIHR258993 (Other Grant/Funding Number: Canadian Institute of Health Research)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No