RecruitingNot Applicable

EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS

France7 participantsStarted 2021-04-16

Plain-language 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.

Who can participate

Age range5 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight

Timeframe: 24 months

Trial details

NCT IDNCT04935918

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Alice FAURE, MD

04.91.96.81.41 alice.faure@ap-hm.fr

View on ClinicalTrials.gov More Bladder Exstrophy trials