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

Last updated: March 28, 2022
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Neurologic Disorders

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT04573673
2018_27
2018-A03045-50
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

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

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 Patientwith benign prostatic hypertrophy (prostate volume > 40 cc) - Last ultrasound scan < 6months. Patient with one or more bladder diverticulum(s) Patient with unilateral or bilateral renalPatient with unilateral or bilateral vesico-ureteral reflux Patient with impaired renalfunction (GFR according to CKD-EPI < 60 ml/min/1.73m2) Patient with a metallic prosthesison the lower limb Patient with a Pacemaker Pregnant patient

Study Design

Total Participants: 68
Study Start date:
December 01, 2021
Estimated Completion Date:
April 30, 2024

Connect with a study center

  • Hop Claude Huriez Chu Lille

    Lille, 59037
    France

    Active - Recruiting

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