Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis. (NEUROSTIM-SEP1)
Multiple Sclerosis, Lower Urinary Tract Symptoms
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Voiding dysfunction, Bladder-sphincter dyssinergia, Tibial neuro-stimulation
Eligibility 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
Sites / Locations
- Hop Claude Huriez Chu LilleRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
PTNS verum
PTNS placebo
Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks.
Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for 12 weeks (same treatment regimen as the experimental group).