ClinicalTrials.gg
Active, not recruitingNCT02039830GROUPUpdated Sep 8, 2025

Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women

An interventional study of Group physiotherapy and Individual one-on-one physiotherapy in Urinary Incontinence and Urinary Stress Incontinence, sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal. Active, not recruiting at 1 site in Canada. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.

Primary conditionUrinary Incontinence, StressRegistry: Urinary IncontinenceReclassifiedWhy we changed it
Registry
Urinary Incontinence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Urinary Incontinence, Stress
Why
  1. The study's listed conditions name Urinary Incontinence, Stress, a narrower term within Urinary Incontinence.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jul 2012, registered Dec 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
362
Allocation
Randomized
Ages
60 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Incontinence
  • Urinary Stress Incontinence

Browse trials for

Keywords

  • female
  • aging
  • physiotherapy
  • pelvic floor
  • rehabilitation
03

In context

Urinary Incontinence, Stress Reclassified

651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.

This study's enrollment of 362 is above the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Compared within Urinary Incontinence, Stress, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Incontinence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • present risk factors known to interfere with the effects of PFM training
  • >2 degree Pop-Q
  • >35
  • chronic constipation
  • have received physiotherapy or surgical treatment within the last year
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
362 participants (actual)

Study arms

  • Experimental
    Group physiotherapy

    12 weekly treatment visit + daily home exercise program

    Behavioral: Group physiotherapy

  • Active comparator
    Individual one-on-one physiotherapy

    12 weekly treatment visit + daily home exercise program

    Behavioral: Individual one-on-one physiotherapy

Interventions

  • BehavioralGroup physiotherapy

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

  • BehavioralIndividual one-on-one physiotherapy

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

06

What researchers measure

Primary outcomes

  1. Change in the number of UI episodes

    evaluated with a 7-day bladder diary

    Time frame: 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

  1. 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)

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation.

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

    evaluated using the International Consultation on Incontinence questionnaire on nocturia (ICIQ-Nocturia)

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation.

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

    evaluated using the 24h PAD test

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.

  4. 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)

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.

  5. 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)

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.

  6. UI related QOL

    evaluated using the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol)

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation

  7. UI related self-efficacy

    evaluated using the Geriatric self-efficacy index

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment

  8. UI related self-efficacy

    evaluated using the Broom PFM Self-efficacy scale

    Time frame: 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

  9. Costs related to interventions

    evaluated using the modified Dowel-Bryant Incontinence Cost Index

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation

  10. Anthropometric measurements

    evaluated using height and weight measurements, which will be combined to report BMI in kg/m\^2

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment

  11. PFM function

    evaluated combining digital palpation (Oxford scale), vaginal atrophy index and dynamometry

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment

  12. PFM morphology

    evaluated using transperineal US

    Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment

  13. Patient reported improvement and satisfaction

    evaluated using Patient global impression of improvement (PGI-I) and Benefit and willingness

    Time frame: 13 weeks after recruitment and 12 months after recruitment

  14. Adherence to intervention and home exercises

    evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program

    Time frame: 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

  15. 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.

    Time frame: 8 years after recruitement for those who completed the 12-month evaluation

07

Study locations

1 site
  • Laboratoire incontinence et vieillissement CRIUGM
    Montreal, Quebec H3W 1W5, Canada
08

References and documents

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. PubMed 29145873 ↗
  • 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. PubMed 35753969 ↗
  • 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. PubMed 32744599 ↗
  • 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. 2026 Jun;37(6):1605-1612. doi: 10.1007/s00192-025-06486-3. Epub 2025 Dec 17. PubMed 41405686 ↗
  • 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. PubMed 39704322 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02039830
Lead sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Responsible party
Chantal Dumoulin (Dr Chantal Dumoulin, researcher and laboratory director, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal) — Principal investigator
First posted
Jan 20, 2014
Start date
Jul 2012
Primary completion
Jun 2018
Completion
Dec 2027 (estimated)
Last update
Sep 8, 2025

Study contacts

Chantal Dumoulin, Ph.D.
principal investigator · Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion