An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight … (NCT07282860) | Clinical Trial Compass
By InvitationNot Applicable
An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
United States100 participantsStarted 2025-11-24
Plain-language summary
This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.
Who can participate
Age range
18 Years
Sex
MALE
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 male participants ≥ 18 years of age at the time of signing the informed consent
. Male anatomy at the time of enrollment
. Currently use diapers, pads, or equivalent at night for urine output management
. Willing to comply with all study procedures in this protocol
. Provision of signed and dated informed consent form
Exclusion criteria
. Has frequent episodes of bowel incontinence; 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
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
Timeframe: From enrollment up to 14 days of treatment
. Has chronic urinogenital infections, active genital herpes; or
. Has Urinary retention; or
. Is expected to have an overnight urine output exceeding 1500 mL. This may include, but is not limited to, individuals with polyuria or those receiving diuretic therapy; or
. Has experience using study devices in the home setting within the last year; or
. Is agitated, combative, and/or uncooperative and may remove the external catheter; or
. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or