EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS

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.

NCT Number	NCT04935918
Lead Sponsor	Assistance Publique Hopitaux De Marseille
Conditions	Bladder Exstrophy
Enrollment	7 participants
Start Date	2021-04-16
Primary Completion	2027-04 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2021-06-23