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NCT Number: NCT04935918

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

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.

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Key information

Conditions

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

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight

    Time frame: 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 outcomes

  1. Number of pads per day (voiding diary)

    Time frame: 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).

  2. Number of incontinence episodes per day (voiding diary)

    Time frame: 6, 12 and 24 months

    Change in number of incontinence episodes per day from baseline to 6, 12 and 24 months (the best : 0)

  3. PIN-Q questionnaire

    Time frame: 6, 12 and 24 months

    Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months

  4. Incidence of urethral stricture and device erosion after ACT implantation

    Time frame: 6, 12 and 24 months

    Cumulative incidence of ACT related clinically relevant urethral structure and device erosions (the best : 0)

Study contacts

Contact information is provided by the study sponsor or research team.

Alice FAURE, MD

CONTACT

[email protected]

04.91.96.81.41

Claire MORANDO

CONTACT

[email protected]

04 91 38 21 83

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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

Acronym: ACT

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Jun 23, 2021
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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