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.
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.
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;
Single group
ACT
DeviceImplantation 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.
Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight
Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in 24 hour Pad weight at 6, 12 and 24 months follow-up compared to the pad weight results at baseline.
Number of pads per day (voiding diary)
Change of number of peds changed per day from baseline to 6, 12 and 24 months (the best : 0 pads changed a day).
Number of incontinence episodes per day (voiding diary)
Change in number of incontinence episodes per day from baseline to 6, 12 and 24 months (the best : 0)
PIN-Q questionnaire
Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months
Incidence of urethral stricture and device erosion after ACT implantation
Cumulative incidence of ACT related clinically relevant urethral structure and device erosions (the best : 0)
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