Daily transcutaneous tibial nerve stimulation to improve bladder emptying in multiple sclerosis
Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
This trial will test whether daily transcutaneous tibial neurostimulation for 30 minutes over 12 weeks can improve bladder emptying in people with multiple sclerosis who use clean intermittent self-catheterization.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT04573673 on ClinicalTrials.gov |
What this trial studies
Adults with multiple sclerosis and bladder-sphincter dyssynergia who empty their bladder using clean intermittent self-catheterization are randomized to receive either active transcutaneous tibial neurostimulation or a placebo (no current) for 30 minutes daily over 12 weeks. The primary outcome is change in bladder voiding efficiency (BVE ratio) measured 12 weeks after randomization. Safety and tolerability are monitored during the treatment period. The control arm follows the same schedule with sham stimulation to blind participants.
Who should consider this trial
Good fit: Ideal candidates are people with multiple sclerosis and bladder-sphincter dyssynergia who rely exclusively on clean intermittent self-catheterization, have EDSS below 6, and have not recently received tibial stimulation, sacral neuromodulation, or botulinum toxin A.
Not a fit: Patients with other neurological diseases, EDSS ≥ 6, recurrent urinary tract infections, uncontrolled detrusor overactivity or bladder compliance disorders, recent tibial or sacral neuromodulation, or recent botulinum toxin or alpha-blocker treatment are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the treatment could improve bladder emptying and reduce incomplete voiding for people with MS who use self-catheterization.
How similar studies have performed: Tibial nerve stimulation and percutaneous tibial nerve stimulation have shown benefit for overactive bladder in prior studies, but evidence specifically for improving voiding dysfunction in MS patients is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 * 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
Where this trial is running
Lille
- Hop Claude Huriez Chu Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Xavier Biardeau, MD — University Hospital, Lille
- Study coordinator: Xavier Biardeau, MD
- Email: xavier.biardeau@chru-lille.fr
- Phone: 03.20.44.41.73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.