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Recruiting NCT04935918

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

No phase Interventional Bladder Exstrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACT.
Who it may be relevant to
Registry conditions: Bladder Exstrophy. Basic parameters: 5 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight [Time frame: 24 months]
Secondary outcome measures (4)
  • Number of pads per day (voiding diary) [Time frame: 6, 12 and 24 months]
  • Number of incontinence episodes per day (voiding diary) [Time frame: 6, 12 and 24 months]
  • PIN-Q questionnaire [Time frame: 6, 12 and 24 months]
  • Incidence of urethral stricture and device erosion after ACT implantation [Time frame: 6, 12 and 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Assistance Publique Hopitaux de Marseille — Marseille

Identifiers

NCT: NCT04935918 · 2019-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗