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

Not Applicable

Recruiting

• Conditions: Bladder Exstrophy
• Interventions: Device: ACT

• Registration Number: NCT04935918
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-16
• Status Verified: 2021-06
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23
• Primary Completion: 2027-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm 1	ACT	Children with bladder exstrophy or isolated epispadias

Primary Outcome Measures

Name	Time	Method
Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight	24 months	Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in 24 hour Pad weight at 6, 12 and 24 months follow-up compared to the pad weight results at baseline.

Secondary Outcome Measures

Name	Time	Method
Number of pads per day (voiding diary)	6, 12 and 24 months	Change of number of peds changed per day from baseline to 6, 12 and 24 months (the best : 0 pads changed a day).
Number of incontinence episodes per day (voiding diary)	6, 12 and 24 months	Change in number of incontinence episodes per day from baseline to 6, 12 and 24 months (the best : 0)
PIN-Q questionnaire	6, 12 and 24 months	Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months
Incidence of urethral stricture and device erosion after ACT implantation	6, 12 and 24 months	Cumulative incidence of ACT related clinically relevant urethral structure and device erosions (the best : 0)

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, Paca, France