Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.

University Hospital, Lille68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Sclerosis Lower Urinary Tract Symptoms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume

BVE will be measured during the multi-channel urodynamic study

Time frame: At 12 weeks after randomization

Secondary Outcomes

Maximal flow rate (mL/s) on multi-channel urodynamic study

Maximal flow rate will be measured during the multi-channel urodynamic study

Time frame: At baseline, At 12 weeks after randomization

Post-void residual volume (mL) on multi-channel urodynamic study

Post-void residual volume will be measured during the multi-channel urodynamic study

Time frame: At 12 weeks after randomization

Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study

Maximal detrusor pressure during micturition will be measured during the multi-channel urodynamic study

Time frame: At 12 weeks after randomization

Mean voided volume (mL) on a three-day ambulatory measure

Mean voided volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days

Time frame: At 12 weeks after randomization

Mean maximal flow rate (mL/s) on a three-day ambulatory measure

Mean maximal flow rate will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days

Time frame: At 12 weeks after randomization

Mean post-void residual volume (mL) on a three-day ambulatory measure

Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days.

Time frame: At 12 weeks after randomization

Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)

Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days

Time frame: At 12 weeks after randomization

Urinary symptoms self-reported questionnaire (USP)

USP : Urinary Symptom Profile

Time frame: At 12 weeks after randomization

Quality of life self-reported questionnaire (Qualiveen)

Qualiveen

Time frame: At 12 weeks after randomization

Difficulty to perform CISC self-reported questionnaire (ICDQ)

ICDQ : Intermittent Catheterization Difficulty Questionnaire

Time frame: At 12 weeks after randomization

Digestive symptoms self-reported questionnaire (NBD)

NBD : Neurogenic Bowel Dysfunction

Time frame: At 12 weeks after randomization

Digestive symptoms self-reported questionnaire (Wexner)

Wexner questionnaire

Time frame: At 12 weeks after randomization

Sexual symptoms self-reported questionnaire (FSFI)

FSFI (female) : Female Sexual Function Index

Time frame: At 12 weeks after randomization

Sexual symptoms self-reported questionnaire ( MSHQ)

MSHQ (male) : Male Sexual Health Questionnaire

Time frame: At 12 weeks after randomization

Frequency of patients with detrusor overactivity on multi-channel urodynamic study

Detrusor overactivity will be objectify during the multi-channel urodynamic study

Time frame: At 12 weeks after randomization

Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity.

Filling volume at first detrusor unhibited contraction will be measured during the multi-channel urodynamic study.

Time frame: At 12 weeks after randomization

Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.

Maximal detrusor pressure will be measured during the multi-channel urodynamic study

Time frame: At 12 weeks after randomization

Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study

Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study

Time frame: At 12 weeks after randomization

Frequency of adverse events occurring during the 12-week follow-up

Adverse events will be exhaustively listed

Time frame: Measured 12 weeks after randomization

Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts