Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PTNS de verum, PTNS placebo.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Lower Urinary Tract Symptoms. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
Overview
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.
Interventions
- 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. - Device 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
Primary outcome measures
- BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume [Time frame: At 12 weeks after randomization]
Secondary outcome measures (12)
- Maximal flow rate (mL/s) on multi-channel urodynamic study [Time frame: At baseline, At 12 weeks after randomization]
- Post-void residual volume (mL) on multi-channel urodynamic study [Time frame: At 12 weeks after randomization]
- Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study [Time frame: At 12 weeks after randomization]
- Mean voided volume (mL) on a three-day ambulatory measure [Time frame: At 12 weeks after randomization]
- Mean maximal flow rate (mL/s) on a three-day ambulatory measure [Time frame: At 12 weeks after randomization]
- Mean post-void residual volume (mL) on a three-day ambulatory measure [Time frame: At 12 weeks after randomization]
- Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL) [Time frame: At 12 weeks after randomization]
- Urinary symptoms self-reported questionnaire (USP) [Time frame: At 12 weeks after randomization]
- Quality of life self-reported questionnaire (Qualiveen) [Time frame: At 12 weeks after randomization]
- Difficulty to perform CISC self-reported questionnaire (ICDQ) [Time frame: At 12 weeks after randomization]
- Digestive symptoms self-reported questionnaire (NBD) [Time frame: At 12 weeks after randomization]
- Digestive symptoms self-reported questionnaire (Wexner) [Time frame: At 12 weeks after randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hop Claude Huriez Chu Lille — Lille
Identifiers
NCT: NCT04573673 · 2018_27 · 2018-A03045-50