Actively Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Led by Assistance Publique Hopitaux De Marseille · Updated on 2021-06-23
7
Participants Needed
1
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Boys and girls older than 5 years with bladder exstrophy or isolated epispadias
- Sphincteric urinary incontinence with leak point pressure less than 45 cm H2O
- Open bladder neck during filling and stress urinary incontinence
- Normal kidney function with eGFR greater than 90 ml/min
- No or stable upper urinary tract dilatation on ultrasound
You will not qualify if you...
- Younger than 5 years or older than 18 years
- Acute or chronic kidney failure
- Progressive deterioration of the upper urinary tract such as hydronephrosis
- Uncontrolled detrusor instability
- Residual urine volume greater than 100 ml after urination
- Bleeding disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Assistance Publique Hopitaux de Marseille
Marseille, PACA, France, 13354
Actively Recruiting
Research Team
A
Alice FAURE, MD
CONTACT
C
Claire MORANDO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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