Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women

NCT02039830 | Active Not Recruiting

• 2 other identifiers: CRC01:GROUPCIHR258993
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence; Urinary Stress Incontinence

Keywords

female; aging; physiotherapy; pelvic floor; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Symptoms and degree to which UI-associated symptoms are troubling or bothersome

  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

  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

  at recruitment, 13 weeks after recruitment and 12 months after recruitment.

• Symptoms and degree to which UI-associated symptoms are troubling or bothersome

  at recruitment, 13 weeks after recruitment and 12 months after recruitment.

• Symptoms and degree to which UI-associated symptoms are troubling or bothersome

  at recruitment, 13 weeks after recruitment and 12 months after recruitment.

Study Arms (2)

Group physiotherapy

EXPERIMENTAL

12 weekly treatment visit + daily home exercise program

Behavioral: Group physiotherapy

Individual one-on-one physiotherapy

ACTIVE COMPARATOR

12 weekly treatment visit + daily home exercise program

Behavioral: Individual one-on-one physiotherapy

Interventions

Group physiotherapy BEHAVIORAL

Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises

Group physiotherapy

Individual one-on-one physiotherapy BEHAVIORAL

Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises

Individual one-on-one physiotherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead

Study Sites (1)

Laboratoire incontinence et vieillissement CRIUGM

Montreal, Quebec, H3W 1W5, Canada

Location

Related Publications (5)

• 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.

  PMID: 35753969 BACKGROUND

• 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.

  PMID: 32744599 BACKGROUND

• 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.

  PMID: 29145873 BACKGROUND

• Cacciari LP, Morin M, Mayrand MH, Dumoulin C. Incontinence in Older Women: When to Expect Meaningful Leakage Reduction from Pelvic Floor Muscle Training. Int Urogynecol J. 2025 Dec 17. doi: 10.1007/s00192-025-06486-3. Online ahead of print.

  PMID: 41405686 DERIVED

• 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.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Chantal Dumoulin, Ph.D.

  Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Chantal Dumoulin, researcher and laboratory director

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: January 20, 2014
• Study Start: July 1, 2012
• Primary Completion: June 1, 2018
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

CA (1)