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

Bladder Exstrophy Clinical Trial

— ACT  

Official title:

PROSPECTIVE STUDY EVALUATING THE SAFETY AND EFFECTIVENESS OF ADJUSTABLE CONTINENCE THERAPY (ACT) BALLOONS FOR THE MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN WITH BLADDER EXSTROPHY OR INCONTINENT EPISPADIAS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04935918
• Other study ID #: 2019-41
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: April 2028

Study information

• Verified date: June 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Alice FAURE, MD
• Phone: 04.91.96.81.41
• Email: alice.faure[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: April 2028
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Exstrophy

Intervention

Device:
• ACT
Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck. The ACT system is a permanent implant designed for the correction of incontinence in patients.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight	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.	24 months
Secondary	Number of pads per day (voiding diary)	Change of number of peds changed per day from baseline to 6, 12 and 24 months (the best : 0 pads changed a day).	6, 12 and 24 months
Secondary	Number of incontinence episodes per day (voiding diary)	Change in number of incontinence episodes per day from baseline to 6, 12 and 24 months (the best : 0)	6, 12 and 24 months
Secondary	PIN-Q questionnaire	Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months	6, 12 and 24 months
Secondary	Incidence of urethral stricture and device erosion after ACT implantation	Cumulative incidence of ACT related clinically relevant urethral structure and device erosions (the best : 0)	6, 12 and 24 months