Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis