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

NCT04935918 | Recruiting DMC

• 1 other identifier: 2019-41
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Exstrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of pads per day (voiding diary)

  6, 12 and 24 months

• Number of incontinence episodes per day (voiding diary)

  6, 12 and 24 months

• PIN-Q questionnaire

  6, 12 and 24 months

• Incidence of urethral stricture and device erosion after ACT implantation

  6, 12 and 24 months

Study Arms (1)

Study Arm 1

EXPERIMENTAL

Children with bladder exstrophy or isolated epispadias

Device: ACT

Interventions

ACT DEVICE

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.

Study Arm 1

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

MeSH Terms

Conditions

Bladder Exstrophy

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Emilie GARRIDO-PRADALIE

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Alice FAURE, MD

CONTACT

04.91.96.81.41; alice.faure@ap-hm.fr

Claire MORANDO

CONTACT

04 91 38 21 83; claire.morando@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 23, 2021
• Study Start: April 16, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

FR (1)