PureWick™ France and U.S. At-Home Pilot Study (NCT05710718) | Clinical Trial Compass
CompletedNot Applicable
PureWick™ France and U.S. At-Home Pilot Study
United States17 participantsStarted 2023-10-31
Plain-language summary
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.
Who can participate
Age range
18 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
. Adult Female Participants \>18 years of age at the time of signing the informed consent.
. Currently use diapers or equivalent at night for urine capture ("Change complet"(French term))
. Willing to comply with all study procedures in the protocol
. Provision of signed and dated informed consent form
Exclusion criteria
. Has frequent episodes of bowel incontinence without a fecal management system in place; or
. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
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
Daily Average Urine Capture Rate (Percentage)
Timeframe: Daily for 28 days during each treatment phase
2
Daily Average Skin Irritation Score Using the Draize Scale
Timeframe: Daily for 28 days during each treatment phase
. Has Urinary tract, vaginal or other chronic infections, active genital herpes; or
. Has Urinary retention; or
. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
. Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or
. Is known to be pregnant at time of enrollment (for women of childbearing age); or