Neurogenic Bladder Due to Spinal Dysraphism Clinical Trial
— BPUAOfficial 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.
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.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | October 30, 2024 |
| Est. primary completion date | October 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - residual volume greater than 100 ml after voiding - bleeding disorders - urethral stenosis - who refused CIC - patent sacral bedsore |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 5 YEARS | |
| Secondary | Evaluation of the quality of life with the PIN-Q score | The child will be asked to answer some items | 5 YEARS |