Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Recruiting · NCT04573673 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Lille
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed.
- Hop Claude Huriez Chu Lille - Lille, France