EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
NCT ID: NCT03351634
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2017-12-30
2024-10-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Children with neurogenic incontinence with spinal dysraphism
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* residual volume greater than 100 ml after voiding
* bleeding disorders
* urethral stenosis
* who refused CIC
* patent sacral bedsore
5 Years
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Urielle DESALBRES
Role: STUDY_DIRECTOR
ASSISTANTE PUBLIQUE HOPITAUX DE MARSEILLE
Locations
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Assistance Publique Hopitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Alice FAURE
Role: primary
Claire MORANDO
Role: backup
Other Identifiers
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2016-A01974-47
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-49
Identifier Type: -
Identifier Source: org_study_id