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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
France
Assistance Publique Hopitaux de Marseille
Recruiting
Marseille
Contact Information
Primary
Alice FAURE, MD
alice.faure@ap-hm.fr
04.91.96.81.41
Backup
Claire MORANDO
claire.morando@ap-hm.fr
04 91 38 21 83
Time Frame
Start Date: April 16, 2021
Estimated Completion Date: April 2028
Participants
Target number of participants: 7
Treatments
Experimental: Study Arm 1
Children with bladder exstrophy or isolated epispadias
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov

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