Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired A… (NCT07099339) | Clinical Trial Compass
CompletedNot Applicable
Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation
Egypt18 participantsStarted 2024-11-02
Plain-language summary
This randomized controlled clinical trial aims to evaluate the effect of pudendal nerve electrical stimulation on fecal incontinence in children with repaired anorectal malformation. Ithe investigators are hypothesized that PNES will significantly improve continence scores, reduce the frequency of fecal incontinent episodes, and enhance the overall quality of life in this vulnerable pediatric population, thereby addressing a critical unmet need in their long-term care.
Children with repaired anorectal malformation may benefit more from combined pudendal nerve electrical stimulation with behavioral therapy and pelvic floor muscles training in improving fecal incontinence.
Who can participate
Age range
6 Years – 9 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:
* children ages ranged from 6 to 9 years and complain of involuntary leakage of feces with a history of anorectal surgical repair MRI revealed the degree of muscle development "Fair/Hypoplastic" identifiable but less developed or asymmetrical muscles
* they can do minimal palpable voluntary contraction of anal sphincter muscle
* they were able to follow instructions during the testing and treatment procedures.
Exclusion Criteria:
* with severe hypoplasia or complete agenesis/absence of parts of the sphincter complex "Poor/Barely Identifiable/Absent", evidenced by MRI,
* children with post-colon surgery other than ARM, neurologic/neuropathic disorder, spinal cord lesion, sensory or hearing deficits.
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.