EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
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
Assistance Publique Hopitaux De Marseille
7 participants
Apr 16, 2021
INTERVENTIONAL
Conditions
Summary
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 around the bladder neck, one on each side of the urethra.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck. The ACT system is a permanent implant designed for the correction of incontinence in patients.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04935918