Multiple Sclerosis (MS) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hop Claude Huriez Chu Lille
RECRUITING
Lille
Contact Information
Primary
Xavier Biardeau, MD
xavier.biardeau@chru-lille.fr
03.20.44.41.73
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 68
Treatments
Experimental: PTNS verum
Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks.
Sham_comparator: PTNS placebo
Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for 12 weeks (same treatment regimen as the experimental group).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov