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NCT04935918
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Conditions: Bladder Exstrophy
Sex: All
Ages: 5 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 7
Sponsor: Assistance Publique Hopitaux De Marseille
Location: Assistance Publique Hopitaux de Marseille Marseille PACA
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 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.
Source: ClinicalTrials.gov (NCT04935918). StuddyBuddy aggregates publicly available trial information.
