An interventional study of Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck in Neurogenic Bladder Due to Spinal Dysraphism, sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 1 site in France. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment
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.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 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.
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
Time frame: 5 YEARS
Evaluation of the quality of life with the PIN-Q score
The child will be asked to answer some items
Time frame: 5 YEARS
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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