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

Primary Purpose

Multiple Sclerosis, Lower Urinary Tract Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PTNS de verum
PTNS placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Voiding dysfunction, Bladder-sphincter dyssinergia, Tibial neuro-stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hop Claude Huriez Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PTNS verum

PTNS placebo

Arm Description

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

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).

Outcomes

Primary Outcome Measures

BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume
BVE will be measured during the multi-channel urodynamic study

Secondary Outcome Measures

Maximal flow rate (mL/s) on multi-channel urodynamic study
Maximal flow rate will be measured during the multi-channel urodynamic study
Post-void residual volume (mL) on multi-channel urodynamic study
Post-void residual volume will be measured during the multi-channel urodynamic study
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
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
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
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.
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
Urinary symptoms self-reported questionnaire (USP)
USP : Urinary Symptom Profile
Quality of life self-reported questionnaire (Qualiveen)
Qualiveen
Difficulty to perform CISC self-reported questionnaire (ICDQ)
ICDQ : Intermittent Catheterization Difficulty Questionnaire
Digestive symptoms self-reported questionnaire (NBD)
NBD : Neurogenic Bowel Dysfunction
Digestive symptoms self-reported questionnaire (Wexner)
Wexner questionnaire
Sexual symptoms self-reported questionnaire (FSFI)
FSFI (female) : Female Sexual Function Index
Sexual symptoms self-reported questionnaire ( MSHQ)
MSHQ (male) : Male Sexual Health Questionnaire
Frequency of patients with detrusor overactivity on multi-channel urodynamic study
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.
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.
Maximal detrusor pressure will be measured during the multi-channel urodynamic study
Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study
Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study
Frequency of adverse events occurring during the 12-week follow-up
Adverse events will be exhaustively listed

Full Information

First Posted
September 28, 2020
Last Updated
March 28, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04573673
Brief Title
Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Acronym
NEUROSTIM-SEP1
Official Title
Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Lower Urinary Tract Symptoms
Keywords
Multiple sclerosis, Voiding dysfunction, Bladder-sphincter dyssinergia, Tibial neuro-stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTNS verum
Arm Type
Experimental
Arm Description
Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks.
Arm Title
PTNS placebo
Arm Type
Sham Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
PTNS de verum
Other Intervention Name(s)
Peristim Pro (CEFAR-COMPEX®)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PTNS placebo
Other Intervention Name(s)
Peristim Pro (CEFAR-COMPEX®
Intervention Description
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
Primary Outcome Measure Information:
Title
BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume
Description
BVE will be measured during the multi-channel urodynamic study
Time Frame
At 12 weeks after randomization
Secondary Outcome Measure Information:
Title
Maximal flow rate (mL/s) on multi-channel urodynamic study
Description
Maximal flow rate will be measured during the multi-channel urodynamic study
Time Frame
At baseline, At 12 weeks after randomization
Title
Post-void residual volume (mL) on multi-channel urodynamic study
Description
Post-void residual volume will be measured during the multi-channel urodynamic study
Time Frame
At 12 weeks after randomization
Title
Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study
Description
Maximal detrusor pressure during micturition will be measured during the multi-channel urodynamic study
Time Frame
At 12 weeks after randomization
Title
Mean voided volume (mL) on a three-day ambulatory measure
Description
Mean voided volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Time Frame
At 12 weeks after randomization
Title
Mean maximal flow rate (mL/s) on a three-day ambulatory measure
Description
Mean maximal flow rate will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Time Frame
At 12 weeks after randomization
Title
Mean post-void residual volume (mL) on a three-day ambulatory measure
Description
Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days.
Time Frame
At 12 weeks after randomization
Title
Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)
Description
Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Time Frame
At 12 weeks after randomization
Title
Urinary symptoms self-reported questionnaire (USP)
Description
USP : Urinary Symptom Profile
Time Frame
At 12 weeks after randomization
Title
Quality of life self-reported questionnaire (Qualiveen)
Description
Qualiveen
Time Frame
At 12 weeks after randomization
Title
Difficulty to perform CISC self-reported questionnaire (ICDQ)
Description
ICDQ : Intermittent Catheterization Difficulty Questionnaire
Time Frame
At 12 weeks after randomization
Title
Digestive symptoms self-reported questionnaire (NBD)
Description
NBD : Neurogenic Bowel Dysfunction
Time Frame
At 12 weeks after randomization
Title
Digestive symptoms self-reported questionnaire (Wexner)
Description
Wexner questionnaire
Time Frame
At 12 weeks after randomization
Title
Sexual symptoms self-reported questionnaire (FSFI)
Description
FSFI (female) : Female Sexual Function Index
Time Frame
At 12 weeks after randomization
Title
Sexual symptoms self-reported questionnaire ( MSHQ)
Description
MSHQ (male) : Male Sexual Health Questionnaire
Time Frame
At 12 weeks after randomization
Title
Frequency of patients with detrusor overactivity on multi-channel urodynamic study
Description
Detrusor overactivity will be objectify during the multi-channel urodynamic study
Time Frame
At 12 weeks after randomization
Title
Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity.
Description
Filling volume at first detrusor unhibited contraction will be measured during the multi-channel urodynamic study.
Time Frame
At 12 weeks after randomization
Title
Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.
Description
Maximal detrusor pressure will be measured during the multi-channel urodynamic study
Time Frame
At 12 weeks after randomization
Title
Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study
Description
Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study
Time Frame
At 12 weeks after randomization
Title
Frequency of adverse events occurring during the 12-week follow-up
Description
Adverse events will be exhaustively listed
Time Frame
Measured 12 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Biardeau, MD
Phone
03.20.44.41.73
Ext
+33
Email
xavier.biardeau@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Biardeau, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

Learn more about this trial

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

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