Multiple SclerosisNEUROSTIM-SEP1NCT04573673
Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
A study testing PTNS de verum in people with Multiple Sclerosis and Lower Urinary Tract Symptoms, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Lower Urinary Tract Symptoms
- What is being tested?
- PTNS de verum
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
About this study
Official title: Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
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.
Read more
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
- Being tested
- PTNS de verum, PTNS placebo
- Keywords
- Multiple sclerosis, Voiding dysfunction, Bladder-sphincter dyssinergia, Tibial neuro-stimulation
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTNS de verumDevice
Also called Peristim Pro (CEFAR-COMPEX®)
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.
PTNS placeboDevice
Also called Peristim Pro (CEFAR-COMPEX®
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
| Study group | Role | What they receive |
|---|---|---|
| PTNS verum | Experimental | Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks. Receives: 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). Receives: Device: PTNS placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume
BVE will be measured during the multi-channel urodynamic study
Measured: At 12 weeks after randomization
Secondary outcomes (19)
Maximal flow rate (mL/s) on multi-channel urodynamic study
Maximal flow rate will be measured during the multi-channel urodynamic study
Measured: At baseline, At 12 weeks after randomization
Post-void residual volume (mL) on multi-channel urodynamic study
Post-void residual volume will be measured during the multi-channel urodynamic study
Measured: At 12 weeks after randomization
Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study
Maximal detrusor pressure during micturition will be measured during the multi-channel urodynamic study
Measured: At 12 weeks after randomization
Mean voided volume (mL) on a three-day ambulatory measure
Mean voided volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Measured: At 12 weeks after randomization
Mean maximal flow rate (mL/s) on a three-day ambulatory measure
Mean maximal flow rate will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Measured: At 12 weeks after randomization
Mean post-void residual volume (mL) on a three-day ambulatory measure
Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days.
Measured: At 12 weeks after randomization
Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)
Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Measured: At 12 weeks after randomization
Urinary symptoms self-reported questionnaire (USP)
USP : Urinary Symptom Profile
Measured: At 12 weeks after randomization
Quality of life self-reported questionnaire (Qualiveen)
Qualiveen
Measured: At 12 weeks after randomization
Difficulty to perform CISC self-reported questionnaire (ICDQ)
ICDQ : Intermittent Catheterization Difficulty Questionnaire
Measured: At 12 weeks after randomization
Digestive symptoms self-reported questionnaire (NBD)
NBD : Neurogenic Bowel Dysfunction
Measured: At 12 weeks after randomization
Digestive symptoms self-reported questionnaire (Wexner)
Wexner questionnaire
Measured: At 12 weeks after randomization
Sexual symptoms self-reported questionnaire (FSFI)
FSFI (female) : Female Sexual Function Index
Measured: At 12 weeks after randomization
Sexual symptoms self-reported questionnaire ( MSHQ)
MSHQ (male) : Male Sexual Health Questionnaire
Measured: At 12 weeks after randomization
Frequency of patients with detrusor overactivity on multi-channel urodynamic study
Detrusor overactivity will be objectify during the multi-channel urodynamic study
Measured: At 12 weeks after randomization
Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity.
Filling volume at first detrusor unhibited contraction will be measured during the multi-channel urodynamic study.
Measured: At 12 weeks after randomization
Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.
Maximal detrusor pressure will be measured during the multi-channel urodynamic study
Measured: At 12 weeks after randomization
Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study
Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study
Measured: At 12 weeks after randomization
Frequency of adverse events occurring during the 12-week follow-up
Adverse events will be exhaustively listed
Measured: Measured 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Dec 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Biardeau, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573673
- Sponsor's protocol ID
- 2018_27
- Other IDs
- 2018-A03045-50
- Acronym
- NEUROSTIM-SEP1
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
- ClinicalTrials.gov ID
- NCT04573673
- Acronym / sponsor ID
- NEUROSTIM-SEP1 / 2018_27
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms
- Keywords
- Multiple sclerosis, Voiding dysfunction, Bladder-sphincter dyssinergia, Tibial neuro-stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTNS verum | Experimental | Device: PTNS de verumPatients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks. |
| PTNS placebo | Sham comparator | Device: PTNS placeboPatients 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTNS de verumAlso: Peristim Pro (CEFAR-COMPEX®)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. | Device | PTNS verum |
| PTNS placeboAlso: Peristim Pro (CEFAR-COMPEX®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 | Device | PTNS placebo |
Primary outcome
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
19 secondary outcomes
Maximal flow rate (mL/s) on multi-channel urodynamic study
Time frame: At baseline, At 12 weeks after randomization
Post-void residual volume (mL) on multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Mean voided volume (mL) on a three-day ambulatory measure
Time frame: At 12 weeks after randomization
Mean maximal flow rate (mL/s) on a three-day ambulatory measure
Time frame: At 12 weeks after randomization
Mean post-void residual volume (mL) on a three-day ambulatory measure
Time frame: At 12 weeks after randomization
Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)
Time frame: At 12 weeks after randomization
Urinary symptoms self-reported questionnaire (USP)
Time frame: At 12 weeks after randomization
Quality of life self-reported questionnaire (Qualiveen)
Time frame: At 12 weeks after randomization
Difficulty to perform CISC self-reported questionnaire (ICDQ)
Time frame: At 12 weeks after randomization
Digestive symptoms self-reported questionnaire (NBD)
Time frame: At 12 weeks after randomization
Digestive symptoms self-reported questionnaire (Wexner)
Time frame: At 12 weeks after randomization
Sexual symptoms self-reported questionnaire (FSFI)
Time frame: At 12 weeks after randomization
Sexual symptoms self-reported questionnaire ( MSHQ)
Time frame: At 12 weeks after randomization
Frequency of patients with detrusor overactivity on multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity.
Time frame: At 12 weeks after randomization
Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.
Time frame: At 12 weeks after randomization
Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Frequency of adverse events occurring during the 12-week follow-up
Time frame: Measured 12 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xavier Biardeau, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS de verum in people with Multiple Sclerosis and Lower Urinary Tract Symptoms, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Biardeau, MD (03.20.44.41.73 ext. +33, xavier.biardeau@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume (time frame: At 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.