Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women … (NCT07427693) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI
Canada36 participantsStarted 2025-01-13
Plain-language 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.
Who can participate
Age range
55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women
* 55 years +
* Stress or mixed UI symptoms with predominantly stress UI symptoms
* At least 3 or more urinary leaks/week
* Able to ambulate safely
* Understand simple instruction in French, written and verbally
* Basic understanding of how to use a tablet or mobile phone
* Willing to participate in a gynecological exam
* Able to properly contract the PFM
* Provide informed consent.
Exclusion Criteria:
* Urge UI symptoms or mixed incontinence with primarily urgency
* Neurological condition
* Grade 3 or 4 of pelvic organ prolapse (POP)
* Any other acute or chronic condition likely to interfere with the mobile app and/or connected object
* Risk factors likely to interfere with the mobile app and/or connected object (i.e.: chronic constipation, chronic cough)
* Medications that can interfere with the mobile app and/or connected object
* Received UI treatments in the last year.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent change in the number of UI episodes
Timeframe: at recruitment and 13 weeks after recruitment
Trial details
NCT IDNCT07427693
SponsorCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal