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

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04935918

Collaborator

(none)

Enrollment

Location

Arm

83.5

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Exstrophy	Device: ACT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 16, 2021

Anticipated Primary Completion Date :

Apr 1, 2027

Anticipated Study Completion Date :

Apr 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Arm 1 Children with bladder exstrophy or isolated epispadias	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.

Arm

Intervention/Treatment

Experimental: Study Arm 1

Children with bladder exstrophy or isolated epispadias

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.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille	Paca	France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: Emilie GARRIDO-PRADALIE, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT04935918

Other Study ID Numbers:

2019-41

First Posted:

Jun 23, 2021

Last Update Posted:

Jun 23, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bladder Exstrophy

Epispadias

Study Results

No Results Posted as of Jun 23, 2021