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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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.
Assistance Publique Hopitaux de Marseille
Marseille, PACA, France
RECRUITINGEvaluation 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.
Time frame: 24 months
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).
Time frame: 6, 12 and 24 months
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)
Time frame: 6, 12 and 24 months
PIN-Q questionnaire
Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months
Time frame: 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)
Time frame: 6, 12 and 24 months
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