Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.

University Hospital, Lille1 site in 1 country68 target enrollmentDecember 1, 2021

ConditionsMultiple Sclerosis Lower Urinary Tract Symptoms

Overview

Phase: N/A
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: University Hospital, Lille
Enrollment: 68
Locations: 1
Primary Endpoint: BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 1, 2021

End Date

June 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: At 12 weeks after randomization

BVE will be measured during the multi-channel urodynamic study

Secondary Outcomes

Maximal flow rate (mL/s) on multi-channel urodynamic study(At baseline, At 12 weeks after randomization)
Post-void residual volume (mL) on multi-channel urodynamic study(At 12 weeks after randomization)
Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study(At 12 weeks after randomization)
Mean voided volume (mL) on a three-day ambulatory measure(At 12 weeks after randomization)
Mean maximal flow rate (mL/s) on a three-day ambulatory measure(At 12 weeks after randomization)
Mean post-void residual volume (mL) on a three-day ambulatory measure(At 12 weeks after randomization)
Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)(At 12 weeks after randomization)
Urinary symptoms self-reported questionnaire (USP)(At 12 weeks after randomization)
Quality of life self-reported questionnaire (Qualiveen)(At 12 weeks after randomization)
Difficulty to perform CISC self-reported questionnaire (ICDQ)(At 12 weeks after randomization)
Digestive symptoms self-reported questionnaire (NBD)(At 12 weeks after randomization)
Digestive symptoms self-reported questionnaire (Wexner)(At 12 weeks after randomization)
Sexual symptoms self-reported questionnaire (FSFI)(At 12 weeks after randomization)
Sexual symptoms self-reported questionnaire ( MSHQ)(At 12 weeks after randomization)
Frequency of patients with detrusor overactivity on multi-channel urodynamic study(At 12 weeks after randomization)
Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity.(At 12 weeks after randomization)
Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.(At 12 weeks after randomization)
Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study(At 12 weeks after randomization)
Frequency of adverse events occurring during the 12-week follow-up(Measured 12 weeks after randomization)