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EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.

RecruitingNAAges 5 Years - 18 YearsAllAssistance Publique Hopitaux De Marseille
NCT03351634 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 periurethra

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📋 Eligibility rules (as published)
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
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What it tests

  • Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck
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Where

1 site
Assistance Publique Hopitaux de Marseille
Marseille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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