Bladder ExstrophyACTNCT04935918
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
A study testing ACT in people with Bladder Exstrophy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Bladder Exstrophy
- What is being tested?
- ACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2021to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- ACT
- Medical subject headings
- Bladder Exstrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTDevice
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 group | Role | What they receive |
|---|---|---|
| Study Arm 1 | Experimental | Children with bladder exstrophy or isolated epispadias Receives: Device: ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
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).
Measured: 6, 12 and 24 months
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)
Measured: 6, 12 and 24 months
PIN-Q questionnaire
Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months
Measured: 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)
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start16 Apr 2021
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder ExstrophyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice Faure, MD, Principal investigator, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935918
- Sponsor's protocol ID
- 2019-41
- Acronym
- ACT
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04935918
- Acronym / sponsor ID
- ACT / 2019-41
- Conditions
- Bladder Exstrophy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm 1 | Experimental | Device: ACTChildren with bladder exstrophy or isolated epispadias |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTImplantation 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. | Device | Study Arm 1 |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Faure, MD principal investigator
Assistance Publique - Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT in people with Bladder Exstrophy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.