Adjustable Continent Therapy for urinary continence in children with spinal dysraphism
Official title: EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY FOR THE MANAGEMENT OF NEUROGENIC INCONTINENCE IN CHILDREN WITH SPINAL DYSRAPHISM.
Run by Assistance Publique Hopitaux De Marseille · NCT03351634 · Data updated 2026-11-12
This study tests an adjustable periurethral balloon system to help children with neurogenic bladder from spinal dysraphism achieve urinary continence.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 18 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | March 30, 2018 |
| Main results expected | March 30, 2027 |
| Study ends | July 30, 2032 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT03351634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children over 5 years with spinal dysraphism and neurogenic incontinence, normal kidney function, and acceptable bladder- and urinary-tract status.
✕Probably not a fit
Patients with active infection, deteriorating upper urinary tract, or detrusor instability may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial involves implanting periurethral, volume-adjustable balloons at the bladder neck to improve urethral coaptation in children with spinal dysraphism and neurogenic incontinence. Eligible participants are children over 5 years with neurogenic sphincteric incontinence and normal renal function, with optional Botox if bladder capacity is insufficient. The approach is minimally invasive and aims to titrate continence through adjustable balloons. Safety and urinary outcomes will be observed, with attention to upper urinary tract status and infection risk. This is conducted under the lead sponsorship of Assistance Publique Hôpitaux de Marseille at their Marseille site.
Why it matters
Potential benefit: If successful, the therapy could improve urinary continence and reduce dependence on more invasive surgeries.
How similar studies have gone: Previous approaches with bulking agents and reconstructive options exist, but this balloon-based, adjustable method is relatively novel in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Boys and girls \> 5 years with spinal dysraphism (occult or open) * Neurogenic sphincteric incontinence (leak point pressure \< 45 cm d'H20, open bladder neck during filling, urinary incontinence) * Normal renal function (eGFR \> 90ml/min) * No (or stable) upper urinary tract dilatation in ultrasound * In case no compliante bladder ( bladder capacity \< 50% for the age) a concomitant injection of botox endoscopically will be performed Exclusion Criteria: * under 5 years with an acquired neurogenic bladder * renal insufficiency (acute or chronic) * evolutive deterioration of the upper urinary tract (hydronephrosis) * active systemic or urinary tract infections * unmanageable detrusor instability * reduced bladder compliance * residual volume greater than 100 ml after voiding * bleeding disorders * urethral stenosis * who refused CIC * patent sacral bedsore
Where it's running
-
Assistance Publique Hopitaux de Marseille
Marseille, France Recruiting
Study contacts
- Principal investigator: Alice Faure, MD — Assistante Publique Hopitaux de Marseille
- Study coordinator: Alice FAURE
- Email: alice.faure@ap-hm.fr
- Phone: 04.91.96.81.41
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.