RecruitingNot ApplicableNCT04573673

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.


Sponsor

University Hospital, Lille

Enrollment

68 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a non-invasive nerve stimulation technique — applying mild electrical pulses to the ankle area (transcutaneous tibial nerve stimulation) — can help people with multiple sclerosis (MS) who have trouble emptying their bladder and rely on self-catheterization. **You may be eligible if...** - You have a confirmed diagnosis of multiple sclerosis - You have a bladder condition called bladder-sphincter dyssynergia (where the bladder and sphincter don't coordinate properly) - You rely on clean intermittent self-catheterization to manage your bladder - You have social insurance coverage **You may NOT be eligible if...** - You have another neurological condition in addition to MS - Your MS disability score is 6 or higher (meaning you need significant assistance to walk) - You have frequent urinary tract infections (more than 3 per year) - You have had tibial nerve stimulation in the last 3 months - You have a pacemaker, metal leg prosthesis, or are pregnant - You have had botulinum toxin injections to the bladder in the last 9 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPTNS 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.

DEVICEPTNS 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

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NCT04573673


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