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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bladder Exstrophy
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
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.
Outcomes
Primary Outcomes
Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight
Time Frame: 24 months
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.
Secondary Outcomes
- Number of pads per day (voiding diary)(6, 12 and 24 months)
- Number of incontinence episodes per day (voiding diary)(6, 12 and 24 months)
- PIN-Q questionnaire(6, 12 and 24 months)
- Incidence of urethral stricture and device erosion after ACT implantation(6, 12 and 24 months)