BridgeMD
Tests treatment safety and results for Bladder Exstrophy
Official title EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
ClinicalTrials.gov ID: NCT04935918
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 18
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, PACA, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, PACA, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.