Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
University Hospital, Lille
68 participants
Dec 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
Interventions
The device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. The amplitude (Volt) will be adjusted by the patient according to the feeling.
The device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. A resistor will be incorporated in the device to block the passage of electric current
Locations(1)
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NCT04573673