Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
NCT ID: NCT04573673
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2021-12-01
2026-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PTNS verum
Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks.
PTNS de verum
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 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).
PTNS placebo
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
Interventions
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PTNS de verum
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 placebo
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Xavier Biardeau, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hop Claude Huriez Chu Lille
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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2018-A03045-50
Identifier Type: OTHER
Identifier Source: secondary_id
2018_27
Identifier Type: -
Identifier Source: org_study_id