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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Exstrophy
• Intervention / Treatment: Device: ACT

• Study Type: Interventional
• Enrollment (Anticipated): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice FAURE, MD; Phone Number: 04.91.96.81.41; Email: alice.faure@ap-hm.fr
• Study Contact Backup: Name: Claire MORANDO; Phone Number: 04 91 38 21 83; Email: claire.morando@ap-hm.fr

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13354
      • Recruiting
      • Assistance Publique Hopitaux de Marseille
      • Contact: Alice FAURE, MD; Phone Number: 04.91.96.81.41; Email: alice.faure@ap-hm.fr
      • Contact: Claire MORANDO; Phone Number: 04 91 38 21 83; Email: claire.morando@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
PIN-Q questionnaire	Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months	6, 12 and 24 months
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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Anticipated): April 1, 2027
• Study Completion (Anticipated): April 1, 2028

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urogenital Abnormalities; Congenital Abnormalities; Urethral Diseases; Epispadias; Bladder Exstrophy
• Other Study ID Numbers: 2019-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No