Overnight Pant Study for Children With Nocturnal Enuresis (NCT05178641) | Clinical Trial Compass
CompletedNot Applicable
Overnight Pant Study for Children With Nocturnal Enuresis
United States32 participantsStarted 2022-01-13
Plain-language summary
This study will evaluate the in-use tolerance of an absorbent disposable underwear pant developed for children with nocturnal enuresis by assessing adverse events. In addition product performance will be assessed by the parent at home via a daily diary.
Who can participate
Age range
4 Years – 7 Years
Sex
ALL
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
. Have you read, understood and signed the Informed Consent document?
. Is your child generally healthy?
. Is your child 4-7 years of age?
. Does your child weigh approximately 37-63 pounds and fit into the test pant?
. Thinking of the past 3 months, does your child wet the bed at night at least once per week?
. Is your child currently using overnight pants or diapers?
. Is your child willing to use their usual and/or supplied overnight pant products every night for the duration of the study?
. Are you and your child willing to refrain from using wet wipes in the pant area for the duration of the clinical trial?
Exclusion criteria
. Does your child have any acute or chronic skin conditions (excluding skin rash) in or around the pant area?
. Does your child currently have (or have a history of) any significant illness or chronic medical condition?
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
Number, Frequency and Severity of Product Related Adverse Events
Timeframe: From admission to discharge, up to 6 weeks
. Does your child currently wear absorbent products during the day?
. Does your child suffer from any other lower urinary tract symptoms (e.g., increased frequency, daytime incontinence, urgency, genital, or lower urinary tract pain) or a history of bladder dysfunction?