Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT05182632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2021-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tele-rehabilitation Group Program for Urinary Incontinence in Older Women
Sponsor:
Université de Montréal
Organization:
Study Overview
Official Title:
Feasibility, Acceptability and Effects of a Tele-rehabilitation Pelvic Floor Muscle Training Group Program for Urinary Incontinence in Older Women
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The recommended treatment for urinary incontinence (UI) in women is individualized pelvic floor muscle training (PFMT), a costly and resource-intensive approach; one Canada is currently unable to meet.
A recent non-inferiority randomized controlled trial just confirmed that group-based PFMT is equally effective but less resource-intensive (more cost-effective) than individual PFMT to treat UI in older women (ClinicalTrials.gov Identifier: NCT02039830). In times of COVID-19 however, with the Quebec, Canada's public health authorities preventing gatherings to stop the virus' spread, the potential of in-person group approaches is temporarily limited. It is thus important to develop innovative ways to deliver this first-line treatment remotely, particularly for those confined at home for whom UI can have a detrimental impact on physical health and quality of life. Ensuring an online option for group-based PFMT would also allow to increase the accessibility of UI treatment for women living in rural or remote areas in Canada, where pelvic floor rehabilitation services are not available or scarce.
To this end, this study will assess the feasibility, acceptability and effects of a tele-rehabilitation PFMT group program for UI in older women.
A recent non-inferiority randomized controlled trial just confirmed that group-based PFMT is equally effective but less resource-intensive (more cost-effective) than individual PFMT to treat UI in older women (ClinicalTrials.gov Identifier: NCT02039830). In times of COVID-19 however, with the Quebec, Canada's public health authorities preventing gatherings to stop the virus' spread, the potential of in-person group approaches is temporarily limited. It is thus important to develop innovative ways to deliver this first-line treatment remotely, particularly for those confined at home for whom UI can have a detrimental impact on physical health and quality of life. Ensuring an online option for group-based PFMT would also allow to increase the accessibility of UI treatment for women living in rural or remote areas in Canada, where pelvic floor rehabilitation services are not available or scarce.
To this end, this study will assess the feasibility, acceptability and effects of a tele-rehabilitation PFMT group program for UI in older women.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: