Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:19 AM
Study NCT ID:
NCT07427693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI
Sponsor:
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Organization:
Study Overview
Official Title:
Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With Urinary Incontinence: a Mixed Method Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-02
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:
OUPS
Brief Summary:
This project aims to evaluate the usability, acceptability, and impact of the Oups! mobile app and a connected Bluetooth dynamometer for at-home PFM training to treat UI. The study will:
1. assess usability and participant feedback on the Oups! app, identifying improvements;
2. evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and
3. measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.
1. assess usability and participant feedback on the Oups! app, identifying improvements;
2. evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and
3. measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.
Detailed Description:
CONTEXT:
Urinary incontinence (UI), or involuntary urine leakage, is a common issue among women over 55. Clinical guidelines recommend pelvic floor muscle (PFM) therapy as the first-line treatment for UI. However, fewer than one-third of older women seek treatment, often due to cost and accessibility barriers. Mobile applications have proven helpful in managing UI symptoms in younger women, offering a low-cost, private solution that encourages adherence. Although numerous apps exist, none are designed specifically for older women, nor have these women been consulted on app usability or effectiveness.
To address this, the investigators have developed the Oups! mobile app, based on our GROUP pelvic floor muscle training (PFMT) program for older women with UI. Additionally, the investigators propose using a connected device-a portable Bluetooth-enabled dynamometer-to measure PFM strength and contraction quality, supporting women in performing effective PFMT. Previously, our lab-developed Montreal Dynamometer provided this feedback but was limited to laboratory use.
This study will examine the usability, acceptability, and impact of combining the Oups! app with the new portable dynamometer for PFM self-training in women aged 55 and over. This innovative approach could potentially improve access to effective UI management and increase treatment uptake in this population.
METHODOLOGY:
A sample of 36 healthy community-dwelling women, aged 55 and older with ≥3 stress or mixed UI episode/week on a 7-day bladder diary and stress or mixed UI symptoms according to the Questionnaire for Incontinence Diagnosis (QUID) will be recruited through regional advertisement and our website. Women will participate in a mixed method study.
Confirming inclusion in the study will be done by telephone using a demographic questionnaire, the QUID, and a 7-day bladder diary. Eligible participants will complete a 1.5-hour pre-intervention assessment at the CRIUGM. After reviewing and signing the informed consent form, they will answer questionnaires addressing UI symptoms and their impact on quality of life. A trained pelvic floor physiotherapist will conduct a gynecological examination to assess the participant's pelvic floor muscle (PFM) function, ensuring the ability to perform an appropriate muscle contraction. Following this, participants will undergo a dynamometric evaluation using the Montreal Dynamometer and a connected vaginal device to measure PFM strength, tone, and endurance. Measurements will be taken in supine and standing positions. At the end of the assessment, participants will receive a tablet with the app installed, their own connected vaginal device, and a user guide outlining the use of both the app and device.
For 12 weeks, participants will engage in PFMT using the Oups! mobile app and a connected vaginal device. The program includes educational capsules, pelvic floor exercises, and motivational capsules. Before each session, participants will insert the connected device, which provides feedback on movement accuracy and muscle strength across four exercises. Real-time results are displayed on the tablet for performance quality and quantity. Exercises should be done five days a week, with flexibility to set a weekly schedule. The program gradually increases in difficulty, with final sessions requiring around 30 minutes daily by the third month. Weekly educational (2-5 minutes) and motivational (2 minutes) capsules are provided, and participants will report daily on any urinary leakage. Participants will keep a daily log of technical issues with the app and device. The research team will also make support calls at weeks 1, 5, and 9 to address questions and ensure smooth progression.
Participants will return to the laboratory for a post-treatment assessment after the 12-week self-training program. This 1.5-hour session includes submitting a 7-day bladder diary and questionnaires assessing UI symptoms (ICIQUI-SF) and quality of life (ICIQ-LUTSqol), as well as a usability questionnaire (FC uMARS) and its validation questionnaire. They will redo the same gynecological exam to assess changes in PFM function using digital palpation and both the original PFM dynamometer and the connected vaginal device. Finally, each participant will participate in a 15-20 minute recorded interview to provide verbal feedback on their experience with the Oups! app and the connected device.
ANTICIPATED RESULTS / SPIN-OFFS:
The findings from this project will help guide further treatment of UI in the context of technology. Ultimately it could help improve accessibility to continence-based treatments for aging women especially for those living in areas where resources to care and specialists in pelvic floor rehabilitation are limited. Moreover, this may also improve outcomes as costs associated with this home exercise approach are minimal compared to in-person treatments typically performed in out-patient care settings.
Urinary incontinence (UI), or involuntary urine leakage, is a common issue among women over 55. Clinical guidelines recommend pelvic floor muscle (PFM) therapy as the first-line treatment for UI. However, fewer than one-third of older women seek treatment, often due to cost and accessibility barriers. Mobile applications have proven helpful in managing UI symptoms in younger women, offering a low-cost, private solution that encourages adherence. Although numerous apps exist, none are designed specifically for older women, nor have these women been consulted on app usability or effectiveness.
To address this, the investigators have developed the Oups! mobile app, based on our GROUP pelvic floor muscle training (PFMT) program for older women with UI. Additionally, the investigators propose using a connected device-a portable Bluetooth-enabled dynamometer-to measure PFM strength and contraction quality, supporting women in performing effective PFMT. Previously, our lab-developed Montreal Dynamometer provided this feedback but was limited to laboratory use.
This study will examine the usability, acceptability, and impact of combining the Oups! app with the new portable dynamometer for PFM self-training in women aged 55 and over. This innovative approach could potentially improve access to effective UI management and increase treatment uptake in this population.
METHODOLOGY:
A sample of 36 healthy community-dwelling women, aged 55 and older with ≥3 stress or mixed UI episode/week on a 7-day bladder diary and stress or mixed UI symptoms according to the Questionnaire for Incontinence Diagnosis (QUID) will be recruited through regional advertisement and our website. Women will participate in a mixed method study.
Confirming inclusion in the study will be done by telephone using a demographic questionnaire, the QUID, and a 7-day bladder diary. Eligible participants will complete a 1.5-hour pre-intervention assessment at the CRIUGM. After reviewing and signing the informed consent form, they will answer questionnaires addressing UI symptoms and their impact on quality of life. A trained pelvic floor physiotherapist will conduct a gynecological examination to assess the participant's pelvic floor muscle (PFM) function, ensuring the ability to perform an appropriate muscle contraction. Following this, participants will undergo a dynamometric evaluation using the Montreal Dynamometer and a connected vaginal device to measure PFM strength, tone, and endurance. Measurements will be taken in supine and standing positions. At the end of the assessment, participants will receive a tablet with the app installed, their own connected vaginal device, and a user guide outlining the use of both the app and device.
For 12 weeks, participants will engage in PFMT using the Oups! mobile app and a connected vaginal device. The program includes educational capsules, pelvic floor exercises, and motivational capsules. Before each session, participants will insert the connected device, which provides feedback on movement accuracy and muscle strength across four exercises. Real-time results are displayed on the tablet for performance quality and quantity. Exercises should be done five days a week, with flexibility to set a weekly schedule. The program gradually increases in difficulty, with final sessions requiring around 30 minutes daily by the third month. Weekly educational (2-5 minutes) and motivational (2 minutes) capsules are provided, and participants will report daily on any urinary leakage. Participants will keep a daily log of technical issues with the app and device. The research team will also make support calls at weeks 1, 5, and 9 to address questions and ensure smooth progression.
Participants will return to the laboratory for a post-treatment assessment after the 12-week self-training program. This 1.5-hour session includes submitting a 7-day bladder diary and questionnaires assessing UI symptoms (ICIQUI-SF) and quality of life (ICIQ-LUTSqol), as well as a usability questionnaire (FC uMARS) and its validation questionnaire. They will redo the same gynecological exam to assess changes in PFM function using digital palpation and both the original PFM dynamometer and the connected vaginal device. Finally, each participant will participate in a 15-20 minute recorded interview to provide verbal feedback on their experience with the Oups! app and the connected device.
ANTICIPATED RESULTS / SPIN-OFFS:
The findings from this project will help guide further treatment of UI in the context of technology. Ultimately it could help improve accessibility to continence-based treatments for aging women especially for those living in areas where resources to care and specialists in pelvic floor rehabilitation are limited. Moreover, this may also improve outcomes as costs associated with this home exercise approach are minimal compared to in-person treatments typically performed in out-patient care settings.
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIHR_191336 | OTHER_GRANT | Canadian Institute of Health Research | View |