CompletedNot Applicable

Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children

Denmark89 participantsStarted 2017-05-01

Plain-language summary

The aim is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating urinary incontinence children with combined daytime incontinence and enuresis. The study will include children who suffers for combined daytime incontinence and enuresis and referred to one of the pediatric departments were offed to participate. Participants are randomized to 8 weeks treatment with either enuresis alarm and timer watch assist urotherapy or solely timer watch assisted urotherapy.

Who can participate

Age range

5 Years – 14 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: * Age 5-14 years * Completed "Tørfisk" (Danish version of the Bower "Dry pie" Incontinence diary 1) and bladder diary (containing frequency and volume of voiding, fluid intake through 48 hours as well as 7 days night registering of nocturnal urine production (NUP) and wet nights.) * A minimum of 2 wet days per week * A minimum of 2 wet nights per week. * Average NUP (aNUP) on wet nights of less than 130 % of expected bladder capacity (EBC=30\*(age+1)) * Obtained oral and written informed consent from the participant and both custody holders. Exclusion Criteria: * Known renal- or urinary tracts anomalies that affects the incontinence * Ongoing urinary tracts infection (UTI) * Ongoing obstipation defined by ROM IV criteria * Glycosuria or proteinuria * Previously received treatment with anticholinergics * Previously received treatment with enuresis alarm * Sign on neurological or structural cause of the incontinence * Reduced compliance for alarm treatment defined as use of the alarm less than 80 % of the nights of the treatment period.

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

Change in Daytime incontinence-score

Timeframe: Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention

Change in Relative number of wet nights

Timeframe: Will be calculated from registrations at baseline and week 8 of intervention

Trial details

NCT IDNCT04260646

SponsorAalborg University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-28

View on ClinicalTrials.gov More Incontinence, Urinary trials