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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Bladder Exstrophy

Treatments: Device: ACT

Study type: Interventional

Funder types: Other

Identifiers

NCT04935918

2019-41

Details and patient eligibility

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.

Enrollment: 7 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Study Arm 1

Experimental group

Description:

Children with bladder exstrophy or isolated epispadias

Treatment:

Device: ACT