TerminatedNot Applicable

Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale

Stopped: Insufficient patient accrual.

United States5 participantsStarted 2011-07

Plain-language summary

The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy. The study hypothesis is that patients who under go cutting the filum terminale - the string-like lower end of the spinal cord - will have improved bladder function at 6-month follow up. Bladder function and its effects on quality of life will be measured before surgery and at 6-month follow up.

Who can participate

Age range

5 Years – 16 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: * Primary or secondary daytime urinary incontinence, persistent over at least 6 months of medical treatment. * Abnormal urodynamic testing * Normal conus on magnetic resonance imaging of the spine * Dysfunctional Voiding Symptom Scale score greater than 6 for girls or greater than 9 for boys Exclusion Criteria: * Bladder outlet obstruction * Bladder atony * Congenital anorectal malformation * Additional diagnoses independently associated with neurogenic bladder dysfunction * Encephalopathy precluding reasonable expectation of attainment of continence * Inability to comply with medical management * Unwillingness to comply with initial or follow up urodynamic testing

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 from baseline in the Pediatric Enuresis Module to Assess Quality of Life

Timeframe: 6-month follow up

Trial details

NCT IDNCT01465581

SponsorNemours Children's Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Neurogenic Incontinence trials