Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study (NCT05715268) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study
United States20 participantsStarted 2023-03-15
Plain-language summary
The goal is to investigate the feasibility and effects of adding "wearables for the bladder" devices to conventional pelvic floor physical therapy (PFPT) to bladder function, in people with multiple sclerosis (MS).
Who can participate
Age range
18 Years – 80 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:
* MS diagnosis
* Assigned Female at birth and whose sex is currently Female
* Mild/moderate bladder dysfunction (bowel/bladder functional systems scores = 0-2 or Bladder control scale \>0)
* California residents
* Wifi in the home and personal smartphone (using Apple operating system)
* Able to walk with or without assistive device
* Manual muscle test score of 2 or more.
Exclusion Criteria:
* Undergone treatment for bladder dysfunction symptoms within 3 months
* Current urinary tract infection
* Recent (\~30 days) relapse
* Any cognitive, dexterity or visual impairment so severe that it precludes use of the wearables for the bladder tool or ability to use a smartphone
* Pregnancy
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
Net Promoter Score
Timeframe: 12 weeks
2
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use
Timeframe: 12 weeks
3
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness