Trials / Recruiting
RecruitingNCT04935918
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 5 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ACT | 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. |
Timeline
- Start date
- 2021-04-16
- Primary completion
- 2027-04-01
- Completion
- 2028-04-01
- First posted
- 2021-06-23
- Last updated
- 2021-06-23
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04935918. Inclusion in this directory is not an endorsement.