Daily transcutaneous tibial nerve stimulation to improve bladder emptying in multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.