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

NCT04573673 | Recruiting

• 2 other identifiers: 2018_272018-A03045-50
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Keywords

Multiple sclerosis; Voiding dysfunction; Bladder-sphincter dyssinergia; Tibial neuro-stimulation

Outcome Measures

Primary Outcomes (1)

• BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume

  BVE will be measured during the multi-channel urodynamic study

  At 12 weeks after randomization

Secondary Outcomes (19)

• Maximal flow rate (mL/s) on multi-channel urodynamic study

  At baseline, At 12 weeks after randomization

• Post-void residual volume (mL) on multi-channel urodynamic study

  At 12 weeks after randomization

• Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study

  At 12 weeks after randomization

• Mean voided volume (mL) on a three-day ambulatory measure

  At 12 weeks after randomization

• Mean maximal flow rate (mL/s) on a three-day ambulatory measure

  At 12 weeks after randomization

Study Arms (2)

PTNS verum

EXPERIMENTAL

Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks.

Device: PTNS de verum

PTNS placebo

SHAM COMPARATOR

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).

Device: PTNS placebo

Interventions

PTNS de verum DEVICE

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.

Also known as: Peristim Pro (CEFAR-COMPEX®)

PTNS verum

PTNS placebo DEVICE

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

Also known as: Peristim Pro (CEFAR-COMPEX®

PTNS placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xavier Biardeau, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Biardeau, MD

CONTACT

03.20.44.41.73; xavier.biardeau@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: December 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)