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Идёт набор NCT07136688

Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

Без фазы С лечением Neurogenic Bladder Due to Spina Bifida

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Stamobil electric stimulator, sham tTNS device.
Кому может быть актуально
Состояния в реестре: Neurogenic Bladder Due to Spina Bifida. Базовые параметры: 4 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Randomized Control Trial of Transcutaneous Tibial Nerve Stimulation for Neurogenic Bladder in the Pediatric Population

Обзор

The purpose of this study is to determine the safety, feasibility, and compliance of a daily home transcutaneous tibial nerve stimulation (tTNS) protocol in children with chronic neurogenic bladder (NB) provided by self or caregiver for 4 weeks and to estimate the efficacy of tTNS

Вмешательства

  • Устройство Stamobil electric stimulator
    The electric stimulation protocol will use stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode for 30 minutes daily. The goal is daily use of tTNS for 4 weeks , 5 days per week.
  • Устройство sham tTNS device
    The electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week

Первичные конечные точки

  • Safety as assessed by the number of adverse events [Срок оценки: from start of trial to end of trial (4 weeks after start)]
  • Feasibility as assessed by the satisfaction surveys [Срок оценки: end of study (4 weeks after baseline)]
  • Compliance of tTNS usage as assessed by the percent of sessions where toe flexion was elicited [Срок оценки: from start of trial to end of trial (4 weeks after start)]
  • Compliance of tTNS usage as assessed by the average current where toe flexion was elicited [Срок оценки: from start of trial to end of trial (4 weeks after start)]
  • Compliance of tTNS usage as assessed by percentage of sessions that bladder medications were taken [Срок оценки: from start of trial to end of trial (4 weeks after start)]
  • Satisfaction as assessed by the survey [Срок оценки: end of study (4 weeks after baseline)]
Вторичные конечные точки (12)
  • Percentage of participants that are able to reduce their overactive bladder (OAB) medications [Срок оценки: end of study (4 weeks after baseline)]
  • percent dose reduction (mg ) achieved [Срок оценки: end of study (4 weeks after baseline)]
  • Change in maximum detrusor pressure (Max Pdet (cmH20)) as assessed by the Urodynamic study (UDS) [Срок оценки: week 0, week 4]
  • Presence of Detrusor overactivity (DO) as assessed by the Urodynamic study (UDS) [Срок оценки: week 0]
  • Presence of Detrusor overactivity (DO) as assessed by the Urodynamic study (UDS) [Срок оценки: Week 4]
  • Change in maximum volume (mL) that bladder can hold before voiding or discomfort as assessed by the Urodynamic study (UDS) [Срок оценки: Week 0, Week 4]
  • Presence of bladder leak as assessed by the Urodynamic study (UDS) [Срок оценки: Week 0]
  • Presence of bladder leak as assessed by the Urodynamic study (UDS) [Срок оценки: Week 4]
  • Change in bladder sensation as assessed by the Urodynamic study (UDS) [Срок оценки: Week 0, Week 4]
  • Change in detrusor compliance as assessed by the Urodynamic study (UDS) [Срок оценки: Week 0, Week 4]
  • Number of incontinence episodes as reported in the voiding diary [Срок оценки: from start of trial to end of trial (4 weeks after start)]
  • Frequency of catheterization as reported in the voiding diary [Срок оценки: from start of trial to end of trial (4 weeks after start)]

Критерии участия

Критерии включения

  • chronic neurogenic bladder
  • Spina Bifida diagnosis
  • Use of overactive bladder medication(s)
  • Stable bladder medications for ≥ 3 months

Критерии исключения

  • Progressive SCI (ex: transverse myelitis, polio, etc.)
  • Other lower urinary tract pathology or surgery
  • 2+ pitting edema in the legs that does not resolve
  • Known peripheral neuropathy or injury to the path of the tibial nerve
  • Cancer in the tibial nerve pathway and/or lower urinary tract
  • Inability to elicit the motor response with electric stimulation
  • Inability to complete the tTNS proficiency checklist (guardians)
  • Non-English speaking (guardians)

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center and Houston — Houston

Идентификаторы

NCT: NCT07136688 · HSC-MS- 24-1198

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗