Tests a nerve stimulation device for bladder emptying problems in multiple sclerosis
Tests a leg-nerve stimulation device against a sham device in people with multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Key facts
- Where
- Lille, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT04573673, who can take part
Where in France
- Hop Claude Huriez Chu LilleLille, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Lille
- Trial code
- NCT04573673
- Record updated
- 23 December 2025
- Original description
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 full original descriptionShow less
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.
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.
Inclusion: 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: Patient treated with a sacral neuro-modulation; Patient with recurrent urinary tract infections (> 3 episodes / year); Patient with a bladder compliance disorder; 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; 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.