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

Multiple Sclerosis Clinical Trial

— NEUROSTIM-SEP1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573673
• Other study ID #: 2018_27
• Secondary ID: 2018-A03045-50
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: April 2024

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Xavier Biardeau, MD
• Phone: 03.20.44.41.73
• Email: xavier.biardeau[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• PTNS de verum
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.
• PTNS placebo
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

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume	BVE will be measured during the multi-channel urodynamic study	At 12 weeks after randomization
Secondary	Maximal flow rate (mL/s) on multi-channel urodynamic study	Maximal flow rate will be measured during the multi-channel urodynamic study	At baseline, At 12 weeks after randomization
Secondary	Post-void residual volume (mL) on multi-channel urodynamic study	Post-void residual volume will be measured during the multi-channel urodynamic study	At 12 weeks after randomization
Secondary	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	At 12 weeks after randomization
Secondary	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	At 12 weeks after randomization
Secondary	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	At 12 weeks after randomization
Secondary	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.	At 12 weeks after randomization
Secondary	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	At 12 weeks after randomization
Secondary	Urinary symptoms self-reported questionnaire (USP)	USP : Urinary Symptom Profile	At 12 weeks after randomization
Secondary	Quality of life self-reported questionnaire (Qualiveen)	Qualiveen	At 12 weeks after randomization
Secondary	Difficulty to perform CISC self-reported questionnaire (ICDQ)	ICDQ : Intermittent Catheterization Difficulty Questionnaire	At 12 weeks after randomization
Secondary	Digestive symptoms self-reported questionnaire (NBD)	NBD : Neurogenic Bowel Dysfunction	At 12 weeks after randomization
Secondary	Digestive symptoms self-reported questionnaire (Wexner)	Wexner questionnaire	At 12 weeks after randomization
Secondary	Sexual symptoms self-reported questionnaire (FSFI)	FSFI (female) : Female Sexual Function Index	At 12 weeks after randomization
Secondary	Sexual symptoms self-reported questionnaire ( MSHQ)	MSHQ (male) : Male Sexual Health Questionnaire	At 12 weeks after randomization
Secondary	Frequency of patients with detrusor overactivity on multi-channel urodynamic study	Detrusor overactivity will be objectify during the multi-channel urodynamic study	At 12 weeks after randomization
Secondary	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.	At 12 weeks after randomization
Secondary	Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.	Maximal detrusor pressure will be measured during the multi-channel urodynamic study	At 12 weeks after randomization
Secondary	Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study	Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study	At 12 weeks after randomization
Secondary	Frequency of adverse events occurring during the 12-week follow-up	Adverse events will be exhaustively listed	Measured 12 weeks after randomization