Evaluating a new balloon therapy for urinary incontinence in children with bladder exstrophy
PROSPECTIVE STUDY EVALUATING THE SAFETY AND EFFECTIVENESS OF ADJUSTABLE CONTINENCE THERAPY (ACT) BALLOONS FOR THE MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN WITH BLADDER EXSTROPHY OR INCONTINENT EPISPADIAS
NA · Assistance Publique Hopitaux De Marseille · NCT04935918
This study is testing a new balloon therapy to see if it can help children with bladder exstrophy control their urination better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 1 site (Marseille, PACA) |
| Trial ID | NCT04935918 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of a minimally invasive procedure using Adjustable Continence Therapy (ACT) balloons for treating urinary incontinence in children diagnosed with bladder exstrophy or isolated epispadias. The ACT therapy involves the surgical implantation of two small adjustable silicone balloons around the bladder neck, designed to improve continence. The study will monitor outcomes related to urinary function and any potential complications associated with the procedure.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 18 years with bladder exstrophy or isolated epispadias and sphincteric incontinence.
Not a fit: Patients under 5 years or over 18 years, those with renal insufficiency, or significant urinary tract issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve urinary continence in affected children, enhancing their quality of life.
How similar studies have performed: While this approach is innovative, similar studies evaluating balloon therapies for urinary incontinence have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Boys and girls \> 5 years with bladder exstrophy or isolated epispadias; * sphincteric incontinence (leak point pressure \< 45 cm d'H20, open bladder neck during filling, stress urinary incontinence); * normal renal function (eGFR \> 90ml/min); * no (or stable) upper urinary tract dilatation in ultrasound. Exclusion Criteria: * under 5 years or more than 18 years old; * renal insufficiency (acute or chronic); * evolutive deterioration of the upper urinary tract (hydronephrosis); * unmanageable detrusor instability; * residual volume greater than 100 ml after voiding; * bleeding disorders.
Where this trial is running
Marseille, PACA
- Assistance Publique Hopitaux de Marseille — Marseille, PACA, France (RECRUITING)
Study contacts
- Study coordinator: Alice FAURE, MD
- Email: alice.faure@ap-hm.fr
- Phone: 04.91.96.81.41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Exstrophy