NCT04573673
Recruiting
Not Applicable
Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
University Hospital, Lille1 site in 1 country68 target enrollmentStarted: December 1, 2021Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Lille
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (1)
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