Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis. (NEUROSTIM-SEP1)

University Hospital, Lille

Status: Enrolling

Conditions: Lower Urinary Tract Symptoms; Multiple Sclerosis

Treatments: Device: PTNS placebo; Device: PTNS de verum

Study type: Interventional

Funder types: Other

Identifiers

NCT04573673

2018_27

2018-A03045-50 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

PTNS verum

Experimental group

Description:

Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks.

Treatment:

Device: PTNS de verum

PTNS placebo

Sham Comparator group

Description:

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).

Treatment:

Device: PTNS placebo