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NCT Number: NCT04573673

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location status: Recruiting

Location contact

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Peristim Pro (CEFAR-COMPEX®)

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

Other names: Peristim Pro (CEFAR-COMPEX®

Primary outcomes

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

    Time frame: At 12 weeks after randomization

    BVE will be measured during the multi-channel urodynamic study

Secondary outcomes

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

    Time frame: At baseline, At 12 weeks after randomization

    Maximal flow rate will be measured during the multi-channel urodynamic study

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

    Time frame: At 12 weeks after randomization

    Post-void residual volume will be measured during the multi-channel urodynamic study

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

    Time frame: At 12 weeks after randomization

    Maximal detrusor pressure during micturition will be measured during the multi-channel urodynamic study

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

    Time frame: At 12 weeks after randomization

    Mean voided volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days

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

    Time frame: At 12 weeks after randomization

    Mean maximal flow rate will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days

  6. Mean post-void residual volume (mL) on a three-day ambulatory measure

    Time frame: At 12 weeks after randomization

    Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days.

  7. Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)

    Time frame: At 12 weeks after randomization

    Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days

  8. Urinary symptoms self-reported questionnaire (USP)

    Time frame: At 12 weeks after randomization

    USP : Urinary Symptom Profile

  9. Quality of life self-reported questionnaire (Qualiveen)

    Time frame: At 12 weeks after randomization

    Qualiveen

  10. Difficulty to perform CISC self-reported questionnaire (ICDQ)

    Time frame: At 12 weeks after randomization

    ICDQ : Intermittent Catheterization Difficulty Questionnaire

  11. Digestive symptoms self-reported questionnaire (NBD)

    Time frame: At 12 weeks after randomization

    NBD : Neurogenic Bowel Dysfunction

  12. Digestive symptoms self-reported questionnaire (Wexner)

    Time frame: At 12 weeks after randomization

    Wexner questionnaire

  13. Sexual symptoms self-reported questionnaire (FSFI)

    Time frame: At 12 weeks after randomization

    FSFI (female) : Female Sexual Function Index

  14. Sexual symptoms self-reported questionnaire ( MSHQ)

    Time frame: At 12 weeks after randomization

    MSHQ (male) : Male Sexual Health Questionnaire

  15. Frequency of patients with detrusor overactivity on multi-channel urodynamic study

    Time frame: At 12 weeks after randomization

    Detrusor overactivity will be objectify during the multi-channel urodynamic study

  16. Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity.

    Time frame: At 12 weeks after randomization

    Filling volume at first detrusor unhibited contraction will be measured during the multi-channel urodynamic study.

  17. Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.

    Time frame: At 12 weeks after randomization

    Maximal detrusor pressure will be measured during the multi-channel urodynamic study

  18. Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study

    Time frame: At 12 weeks after randomization

    Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study

  19. Frequency of adverse events occurring during the 12-week follow-up

    Time frame: Measured 12 weeks after randomization

    Adverse events will be exhaustively listed

Study contacts

Contact information is provided by the study sponsor or research team.

Xavier Biardeau, MD

CONTACT

[email protected]

03.20.44.41.73 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: NEUROSTIM-SEP1

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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