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

September 4, 2025 updated by: Chantal Dumoulin, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
362

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the number of UI episodes
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
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.
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
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.
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
Time Frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
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
Time Frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
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
Time Frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
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
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
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
Time Frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
evaluated using the Geriatric self-efficacy index
at recruitment, 13 weeks after recruitment and 12 months after recruitment
UI related self-efficacy
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
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
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
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
Time Frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
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
Time Frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
evaluated combining digital palpation (Oxford scale), vaginal atrophy index and dynamometry
at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM morphology
Time Frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
evaluated using transperineal US
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Patient reported improvement and satisfaction
Time Frame: 13 weeks after recruitment and 12 months after recruitment
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
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
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
Time Frame: 8 years after recruitement for those who completed the 12-month evaluation
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chantal Dumoulin, Ph.D., Centre de recherche de l'institut Universitaire de Gériatrie de Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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