Actively Recruiting
Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Led by University Hospital, Lille · Updated on 2025-12-23
68
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple sclerosis
- Presence of bladder-sphincter dyssynergia
- Use of clean intermittent self-catheterization as the only bladder management method
- Written informed consent provided
- Socially insured patient
- Willingness to comply with all study procedures and duration
You will not qualify if you...
- Other neurological diseases besides multiple sclerosis
- Expanded Disability Status Scale (EDSS) score of 6 or higher
- More than 3 urinary tract infections in the past year
- Uncontrolled overactive bladder
- Uncontrolled detrusor hyperactivity
- Bladder compliance disorder
- Tibial neuro-stimulation treatment within the last 3 months
- Sacral neuro-modulation treatment
- Intradermal botulinum toxin A injection within the last 9 months
- Alpha-blocker treatment within the last month
- Benign prostatic hypertrophy with prostate volume over 40 cc (ultrasound within last 6 months)
- Presence of one or more bladder diverticula
- Unilateral or bilateral renal conditions
- Unilateral or bilateral vesico-ureteral reflux
- Impaired renal function (GFR less than 60 ml/min/1.73m2)
- Metallic prosthesis on the lower limb
- Pacemaker
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hop Claude Huriez Chu Lille
Lille, France, 59037
Actively Recruiting
Research Team
X
Xavier Biardeau, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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