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RECRUITINGINTERVENTIONAL

Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.

Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The present trial is designed to assess the efficacy and safety of transcutaneous tibial neuro-stimulation (TTNS) in improving bladder emptying in multiple sclerosis (MS) patients. Patients presenting with MS and performing clean intermittent self-catheterization (CISC) to empty the bladder in the context of voiding dysfunction, will be eligible. Included patients will be randomly assigned to two distinct arms * PTNS de verum : patients will be treated with transcutaneous tibial neuro-stimulation at a rate of one session of 30 consecutive minutes daily for a period of 12 weeks. * PTNS placebo : Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for a period of 12 weeks (same treatment regimen as the experimental group). Efficacy in improving voiding dysfunction will be assessed 12 weeks after randomization using the BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient with a diagnosis of multiple sclerosis - Patient with bladder-sphincter dyssinergia - Patient using clean intermittent self-catheterization as exclusive bladder management - Patient who has given written consent - Socially insured patient - Patient willing to comply with all study procedures and study duration Who Should NOT Join This Trial: - Patient with other associated neurological pathology - Patient with an Expanded Disability Status Scale (EDSS) score ≥ 6 - Patient with recurrent urinary tract infections (\> 3 episodes / year) - Patient with uncontrolled overactive bladder - Patient with uncontrolled detrusor hyperactivity - Patient with a bladder compliance disorder - Patient with tibial neuro-stimulation in the last 3 months - Patient treated with a sacral neuro-modulation - Patient who has received an intradermal injection of botulinum toxin A within the last 9 -months Patient who received alpha-blocker treatment within the last month Patient with benign prostatic hypertrophy (prostate volume \> 40 cc) - Last ultrasound scan \< 6 months. Patient with one or more bladder diverticulum(s) Patient with unilateral or bilateral renal Patient with unilateral or bilateral vesico-ureteral reflux Patient with impaired renal function (GFR according to CKD-EPI \< 60 ml/min/1.73m2) Patient with a metallic prosthesis on the lower limb Patient with a Pacemaker Pregnant patient Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patient with a diagnosis of multiple sclerosis * Patient with bladder-sphincter dyssinergia * Patient using clean intermittent self-catheterization as exclusive bladder management * Patient who has given written consent * Socially insured patient * Patient willing to comply with all study procedures and study duration Exclusion Criteria: * Patient with other associated neurological pathology * Patient with an Expanded Disability Status Scale (EDSS) score ≥ 6 * Patient with recurrent urinary tract infections (\> 3 episodes / year) * Patient with uncontrolled overactive bladder * Patient with uncontrolled detrusor hyperactivity * Patient with a bladder compliance disorder * Patient with tibial neuro-stimulation in the last 3 months * Patient treated with a sacral neuro-modulation * Patient who has received an intradermal injection of botulinum toxin A within the last 9 -months Patient who received alpha-blocker treatment within the last month Patient with benign prostatic hypertrophy (prostate volume \> 40 cc) - Last ultrasound scan \< 6 months. Patient with one or more bladder diverticulum(s) Patient with unilateral or bilateral renal Patient with unilateral or bilateral vesico-ureteral reflux Patient with impaired renal function (GFR according to CKD-EPI \< 60 ml/min/1.73m2) Patient with a metallic prosthesis on the lower limb Patient with a Pacemaker Pregnant patient

Treatments Being Tested

DEVICE

PTNS de verum

The device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. The amplitude (Volt) will be adjusted by the patient according to the feeling.

DEVICE

PTNS placebo

The device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. A resistor will be incorporated in the device to block the passage of electric current

Locations (1)

Hop Claude Huriez Chu Lille
Lille, France