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

Primary Purpose

Bladder Exstrophy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ACT
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Exstrophy

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm 1

Arm Description

Children with bladder exstrophy or isolated epispadias

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)
PIN-Q questionnaire
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
Cumulative incidence of ACT related clinically relevant urethral structure and device erosions (the best : 0)

Full Information

First Posted
June 8, 2021
Last Updated
June 15, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04935918
Brief Title
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Acronym
ACT
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Exstrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Arm 1
Arm Type
Experimental
Arm Description
Children with bladder exstrophy or isolated epispadias
Intervention Type
Device
Intervention Name(s)
ACT
Intervention Description
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 Measure Information:
Title
Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of pads per day (voiding diary)
Description
Change of number of peds changed per day from baseline to 6, 12 and 24 months (the best : 0 pads changed a day).
Time Frame
6, 12 and 24 months
Title
Number of incontinence episodes per day (voiding diary)
Description
Change in number of incontinence episodes per day from baseline to 6, 12 and 24 months (the best : 0)
Time Frame
6, 12 and 24 months
Title
PIN-Q questionnaire
Description
Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months
Time Frame
6, 12 and 24 months
Title
Incidence of urethral stricture and device erosion after ACT implantation
Description
Cumulative incidence of ACT related clinically relevant urethral structure and device erosions (the best : 0)
Time Frame
6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice FAURE, MD
Phone
04.91.96.81.41
Email
alice.faure@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire MORANDO
Phone
04 91 38 21 83
Email
claire.morando@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie GARRIDO-PRADALIE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
State/Province
Paca
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice FAURE, MD
Phone
04.91.96.81.41
Email
alice.faure@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Claire MORANDO
Phone
04 91 38 21 83
Email
claire.morando@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

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

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