EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Recruiting
N/A
Interventional Study
Bladder Exstrophy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 5 – 18
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 7 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Other
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About This Trial
The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias.
The ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed ar…
Trial Locations
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Eligibility 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 t…
Contacts