NCT04573673Recruiting
Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 28 Sept 2020
- Start date
- 1 Dec 2021
- Primary completion date
- Jun 2026
- Lead sponsor
- University Hospital, Lille
- Diseases
- Multiple sclerosis
- NCT number
- NCT04573673
What you commit to
- Study type: Interventional
- Planned participants: 68
- From 1 Dec 2021 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient treated with a sacral neuro-modulation
Other illness
- Patient with recurrent urinary tract infections (\> 3 episodes / year)
- Patient with a bladder compliance disorder
Lab values
- 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
Other
- Patient with other associated neurological pathology
- Patient with an Expanded Disability Status Scale (EDSS) score ≥ 6
- Patient with uncontrolled overactive bladder
- Patient with uncontrolled detrusor hyperactivity
- Patient with tibial neuro-stimulation in the last 3 months
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hop Claude Huriez Chu Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.