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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04935918

Acronym

ACT

Enrollment

Registered

2021-06-23

Start date

2021-04-16

Completion date

2028-04-30

Last updated

2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Exstrophy

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.

Interventions

DEVICEACT

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Contacts

Primary ContactAlice FAURE, MD

alice.faure@ap-hm.fr04.91.96.81.41

Backup ContactClaire MORANDO

claire.morando@ap-hm.fr04 91 38 21 83

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026