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

Официальное название

Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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

Первичные конечные точки

• BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume [Срок оценки: At 12 weeks after randomization]

Вторичные конечные точки (12)

• Maximal flow rate (mL/s) on multi-channel urodynamic study [Срок оценки: At baseline, At 12 weeks after randomization]
• Post-void residual volume (mL) on multi-channel urodynamic study [Срок оценки: At 12 weeks after randomization]
• Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study [Срок оценки: At 12 weeks after randomization]
• Mean voided volume (mL) on a three-day ambulatory measure [Срок оценки: At 12 weeks after randomization]
• Mean maximal flow rate (mL/s) on a three-day ambulatory measure [Срок оценки: At 12 weeks after randomization]
• Mean post-void residual volume (mL) on a three-day ambulatory measure [Срок оценки: At 12 weeks after randomization]
• Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL) [Срок оценки: At 12 weeks after randomization]
• Urinary symptoms self-reported questionnaire (USP) [Срок оценки: At 12 weeks after randomization]
• Quality of life self-reported questionnaire (Qualiveen) [Срок оценки: At 12 weeks after randomization]
• Difficulty to perform CISC self-reported questionnaire (ICDQ) [Срок оценки: At 12 weeks after randomization]
• Digestive symptoms self-reported questionnaire (NBD) [Срок оценки: At 12 weeks after randomization]
• Digestive symptoms self-reported questionnaire (Wexner) [Срок оценки: At 12 weeks after randomization]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hop Claude Huriez Chu Lille — Lille

Идентификаторы

NCT: NCT04573673 · 2018_27 · 2018-A03045-50

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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