Clinical trial NCT04573673: Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Official title: Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lower Urinary Tract Symptoms
Keywords: Multiple sclerosis
Voiding dysfunction
Bladder-sphincter dyssinergia
Tibial neuro-stimulation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume
timeFrame: At 12 weeks after randomization
Secondary outcomes:
measure: Maximal flow rate (mL/s) on multi-channel urodynamic study
timeFrame: At baseline, At 12 weeks after randomization
measure: Post-void residual volume (mL) on multi-channel urodynamic study
timeFrame: At 12 weeks after randomization
measure: Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study
timeFrame: At 12 weeks after randomization
measure: Mean voided volume (mL) on a three-day ambulatory measure
timeFrame: At 12 weeks after randomization
measure: Mean maximal flow rate (mL/s) on a three-day ambulatory measure
timeFrame: At 12 weeks after randomization
measure: Mean post-void residual volume (mL) on a three-day ambulatory measure
timeFrame: At 12 weeks after randomization
measure: Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)
timeFrame: At 12 weeks after randomization
measure: Urinary symptoms self-reported questionnaire (USP)
timeFrame: At 12 weeks after randomization
measure: Quality of life self-reported questionnaire (Qualiveen)
timeFrame: At 12 weeks after randomization
measure: Difficulty to perform CISC self-reported questionnaire (ICDQ)
timeFrame: At 12 weeks after randomization
measure: Digestive symptoms self-reported questionnaire (NBD)
timeFrame: At 12 weeks after randomization
measure: Digestive symptoms self-reported questionnaire (Wexner)
timeFrame: At 12 weeks after randomization
measure: Sexual symptoms self-reported questionnaire (FSFI)
timeFrame: At 12 weeks after randomization
measure: Sexual symptoms self-reported questionnaire ( MSHQ)
timeFrame: At 12 weeks after randomization
measure: Frequency of patients with detrusor overactivity on multi-channel urodynamic study
timeFrame: At 12 weeks after randomization
measure: Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity.
timeFrame: At 12 weeks after randomization
measure: Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity.
timeFrame: At 12 weeks after randomization
measure: Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study
timeFrame: At 12 weeks after randomization
measure: Frequency of adverse events occurring during the 12-week follow-up
timeFrame: Measured 12 weeks after randomization
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Xavier Biardeau, MD
role: PRINCIPAL_INVESTIGATOR
References: