Neurogenic Bladder Due to Spinal DysraphismBPUANCT03351634
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
A study testing Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck in people with Neurogenic Bladder Due to Spinal Dysraphism, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Urinary continence is still a difficult goal to achieve in neurogenic bladder patients. Conservative treatment of neurogenic urinary incontinence using clean intermittent catheterization in conjunction with pharmacological therapy, notably anticholinergic medication +/- adrenergic agents, may produce continence in a… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Neurogenic Bladder Due to Spinal Dysraphism
- What is being tested?
- Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2018to 30 Jul 2032
- 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 spinal dysraphism (occult or open)
- Neurogenic sphincteric incontinence (leak point pressure < 45 cm d'H20, open bladder neck during filling, urinary incontinence)
- Normal renal function (eGFR > 90ml/min)
- No (or stable) upper urinary tract dilatation in ultrasound
- In case no compliante bladder ( bladder capacity < 50% for the age) a concomitant injection of botox endoscopically will be performed
Who cannot join
- under 5 years with an acquired neurogenic bladder
- renal insufficiency (acute or chronic)
- evolutive deterioration of the upper urinary tract (hydronephrosis)
- active systemic or urinary tract infections
- unmanageable detrusor instability
- reduced bladder compliance
Show all 11Show fewer
- residual volume greater than 100 ml after voiding
- bleeding disorders
- urethral stenosis
- who refused CIC
- patent sacral bedsore
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Alice FAURE, 04.91.96.81.41, alice.faure@ap-hm.fr
About this study
Official title: EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY FOR THE MANAGEMENT OF NEUROGENIC INCONTINENCE IN CHILDREN WITH SPINAL DYSRAPHISM.
Urinary continence is still a difficult goal to achieve in neurogenic bladder patients. Conservative treatment of neurogenic urinary incontinence using clean intermittent catheterization in conjunction with pharmacological therapy, notably anticholinergic medication +/- adrenergic agents, may produce continence in a variable number of patients. In other patients, reconstructive surgery of the bladder and/or bladder neck is necessary to achieve urinary continence. Surgical treatment options to increase bladder outlet resistance in patients with neurogenic bladder include injection of bulking agents around the bladder neck, bladder neck reconstruction, fascial sling procedures and Artificial Urinary Sphincter.
The Adjustable Continence Therapy system (ACT) or periurethral adjustable balloons are a minimally invasive device consisting of two volume-adjustable balloons implanted periurethrally at the bladder neck as a method of augmenting titration for urethral coaptation. Adjustable means that such system would be adaptable to the individual clinical condition.
Read more
Originally conceived and developed as a treatment for female stress urinary incontinence, the technique has been then adapted and balloons were globally developed for the use in postprostatectomy incontinence. The published success rate in male after prostatectomy and in women was respectively 56 to 92% and 60 to 83%.
The investigators hypothesize that the use of ACT for treating incontinence in children secondary to neurogenic sphincter incontinence could compress the urethra or the bladder neck, acting as an extrinsic occlusive system increasing passive and dynamic urethral and bladder resistance.
Goal of the study:
To prospectively assess the efficacy and safety of periurethral adjustable balloons in the treatment of neurogenic incontinence in children with spinal dysraphism.
Material and methods :
A prospective study will be performed at La Timone Enfants hospital and La Nord hospital in Marseille, France. Boys and girls at least at school age (5 or 6 years) with neurogenic incontinence due to outlet issues (low detrusor leak point pressure and low stress leak point pressure) with spinal dysraphism will be recruited.
The ACT balloon is an implantable medical device developed and furnished for free by Uromedica (Irvine, CA, USA). The procedure is performed under general anaesthesia using the same implantation technique as published in adult population.
- Being tested
- Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neckDevice
The ACT system is a permanent implant designed for the correction of incontinence in patients.
| Study group | Role | What they receive |
|---|---|---|
| Children with neurogenic incontinence with spinal dysraphism | Experimental | Not described Receives: Device: Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of urinary continence with the Schulte-Baukloh score and 24hours pad-test
Evaluation of urinary continence with mictional schedule and 24hours pad-test (Patients will be classified as "dry" if they will be using no pads or a single ''security pad'' per day; "significantly improved" if a reduction >50% in pad usage (usually representing 2- 5 pads/day, depending on preoperative pad use); and little/no improvement (>5 pads/day and <50% improvement against baseline) and the Schulte-Baukloh score
Measured: 5 YEARS
Secondary outcomes (1)
Evaluation of the quality of life with the PIN-Q score
The child will be asked to answer some items
Measured: 5 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start30 Mar 2018
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Bladder Due to Spinal DysraphismStudies 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
- 10 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, ASSISTANTE PUBLIQUE HOPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351634
- Sponsor's protocol ID
- 2016-49
- Other IDs
- 2016-A01974-47
- Acronym
- BPUA
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2017
- Last updated
- 29 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY FOR THE MANAGEMENT OF NEUROGENIC INCONTINENCE IN CHILDREN WITH SPINAL DYSRAPHISM.
- ClinicalTrials.gov ID
- NCT03351634
- Acronym / sponsor ID
- BPUA / 2016-49
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jul 2032 (estimated)
- First posted
- 24 Nov 2017 (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.
Urinary continence is still a difficult goal to achieve in neurogenic bladder patients. Conservative treatment of neurogenic urinary incontinence using clean intermittent catheterization in conjunction with pharmacological therapy, notably anticholinergic medication +/- adrenergic agents, may produce continence in a variable number of patients. In other patients, reconstructive surgery of the bladder and/or bladder neck is necessary to achieve urinary continence. Surgical treatment options to increase bladder outlet resistance in patients with neurogenic bladder include injection of bulking agents around the bladder neck, bladder neck reconstruction, fascial sling procedures and Artificial Urinary Sphincter.
The Adjustable Continence Therapy system (ACT) or periurethral adjustable balloons are a minimally invasive device consisting of two volume-adjustable balloons implanted periurethrally at the bladder neck as a method of augmenting titration for urethral coaptation. Adjustable means that such system would be adaptable to the individual clinical condition.
Originally conceived and developed as a treatment for female stress urinary incontinence, the technique has been then adapted and balloons were globally developed for the use in postprostatectomy incontinence. The published success rate in male after prostatectomy and in women was respectively 56 to 92% and 60 to 83%.
The investigators hypothesize that the use of ACT for treating incontinence in children secondary to neurogenic sphincter incontinence could compress the urethra or the bladder neck, acting as an extrinsic occlusive system increasing passive and dynamic urethral and bladder resistance.
Goal of the study:
To prospectively assess the efficacy and safety of periurethral adjustable balloons in the treatment of neurogenic incontinence in children with spinal dysraphism.
Material and methods :
A prospective study will be performed at La Timone Enfants hospital and La Nord hospital in Marseille, France. Boys and girls at least at school age (5 or 6 years) with neurogenic incontinence due to outlet issues (low detrusor leak point pressure and low stress leak point pressure) with spinal dysraphism will be recruited.
The ACT balloon is an implantable medical device developed and furnished for free by Uromedica (Irvine, CA, USA). The procedure is performed under general anaesthesia using the same implantation technique as published in adult population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with neurogenic incontinence with spinal dysraphism | Experimental | Device: Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Boys and girls > 5 years with spinal dysraphism (occult or open)
- Neurogenic sphincteric incontinence (leak point pressure < 45 cm d'H20, open bladder neck during filling, urinary incontinence)
- Normal renal function (eGFR > 90ml/min)
- No (or stable) upper urinary tract dilatation in ultrasound
- In case no compliante bladder ( bladder capacity < 50% for the age) a concomitant injection of botox endoscopically will be performed
Key exclusion criteria (11 listed)
- under 5 years with an acquired neurogenic bladder
- renal insufficiency (acute or chronic)
- evolutive deterioration of the upper urinary tract (hydronephrosis)
- active systemic or urinary tract infections
- unmanageable detrusor instability
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 |
|---|---|---|
| Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neckThe ACT system is a permanent implant designed for the correction of incontinence in patients. | Device | Children with neurogenic incontinence with spinal dysraphism |
Primary outcome
Measurement of urinary continence with the Schulte-Baukloh score and 24hours pad-test
Time frame: 5 YEARS
Evaluation of urinary continence with mictional schedule and 24hours pad-test (Patients will be classified as "dry" if they will be using no pads or a single ''security pad'' per day; "significantly improved" if a reduction >50% in pad usage (usually representing 2- 5 pads/day, depending on preoperative pad use); and little/no improvement (>5 pads/day and <50% improvement against baseline) and the Schulte-Baukloh score
1 secondary outcome
Evaluation of the quality of life with the PIN-Q score
Time frame: 5 YEARS
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 29 Oct 2026.
Related trials for Neurogenic Bladder Due to Spinal Dysraphism
Recruiting
Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder
Neurogenic Bladder Due to Spina Bifida
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.
Alice Faure, MD principal investigator
ASSISTANTE PUBLIQUE HOPITAUX 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 Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck in people with Neurogenic Bladder Due to Spinal Dysraphism, 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 29 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?
Contact Alice FAURE (04.91.96.81.41, alice.faure@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of urinary continence with the Schulte-Baukloh score and 24hours pad-test (time frame: 5 YEARS). 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 29 Oct 2026.