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

Not Applicable

• Conditions: Multiple Sclerosis; Lower Urinary Tract Symptoms
• Interventions: Device: PTNS placebo; Device: PTNS de verum

• Registration Number: NCT04573673
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-05
• Study Start: 2021-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTNS placebo	PTNS placebo	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).
PTNS verum	PTNS de verum	Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks.

Primary Outcome Measures

Name	Time	Method
BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume	At 12 weeks after randomization	BVE will be measured during the multi-channel urodynamic study

Secondary Outcome Measures

Name	Time	Method
Urinary symptoms self-reported questionnaire (USP)	At 12 weeks after randomization	USP : Urinary Symptom Profile
Maximal flow rate (mL/s) on multi-channel urodynamic study	At baseline, At 12 weeks after randomization	Maximal flow rate will be measured during the multi-channel urodynamic study
Post-void residual volume (mL) on multi-channel urodynamic study	At 12 weeks after randomization	Post-void residual volume will be measured during the multi-channel urodynamic study
Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study	At 12 weeks after randomization	Maximal detrusor pressure during micturition will be measured during the multi-channel urodynamic study
Mean voided volume (mL) on a three-day ambulatory measure	At 12 weeks after randomization	Mean voided volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Mean maximal flow rate (mL/s) on a three-day ambulatory measure	At 12 weeks after randomization	Mean maximal flow rate will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Mean post-void residual volume (mL) on a three-day ambulatory measure	At 12 weeks after randomization	Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days.
Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)	At 12 weeks after randomization	Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Quality of life self-reported questionnaire (Qualiveen)	At 12 weeks after randomization	Qualiveen
Difficulty to perform CISC self-reported questionnaire (ICDQ)	At 12 weeks after randomization	ICDQ : Intermittent Catheterization Difficulty Questionnaire
Digestive symptoms self-reported questionnaire (NBD)	At 12 weeks after randomization	NBD : Neurogenic Bowel Dysfunction
Digestive symptoms self-reported questionnaire (Wexner)	At 12 weeks after randomization	Wexner questionnaire
Sexual symptoms self-reported questionnaire (FSFI)	At 12 weeks after randomization	FSFI (female) : Female Sexual Function Index
Sexual symptoms self-reported questionnaire ( MSHQ)	At 12 weeks after randomization	MSHQ (male) : Male Sexual Health Questionnaire
Frequency of patients with detrusor overactivity on multi-channel urodynamic study	At 12 weeks after randomization	Detrusor overactivity will be objectify during the multi-channel urodynamic study
Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity.	At 12 weeks after randomization	Filling volume at first detrusor unhibited contraction will be measured during the multi-channel urodynamic study.
Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.	At 12 weeks after randomization	Maximal detrusor pressure will be measured during the multi-channel urodynamic study
Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study	At 12 weeks after randomization	Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study
Frequency of adverse events occurring during the 12-week follow-up	Measured 12 weeks after randomization	Adverse events will be exhaustively listed

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France