Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Официальное название

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial

Обзор

The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.

Вмешательства

• Устройство iTNS
  The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.
• Устройство Sham iTNS
  The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.

Первичные конечные точки

• Safety as assessed by the number of device-related adverse events [Срок оценки: From baseline to 8 weeks]
• Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs. [Срок оценки: From baseline to week 8]
• Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy [Срок оценки: From baseline to week 8]
• Feasibility of Injectrode procedure as assessed by surveys [Срок оценки: Week 8]
• Physician acceptability of Injectrode device as assessed by a survey [Срок оценки: Week 8]
• Participant acceptability of Injectrode device as assessed by a survey [Срок оценки: Week 8]
• Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview [Срок оценки: Week 8]

Вторичные конечные точки (12)

• Number of participants for whom bladder medication dosage reduced [Срок оценки: from baseline to 8 weeks]
• Change in magnitude of dosage of medication [Срок оценки: from baseline to 8 weeks]
• Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20. [Срок оценки: Baseline, Week 4, and Week 8]
• Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics. [Срок оценки: baseline, Week 4, and Week 8]
• Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort. [Срок оценки: baseline, Week 4, and Week 8]
• Change in the presence or absence of leaks during urodynamics. [Срок оценки: baseline, Week 4, and Week 8]
• Change in bladder sensation during urodynamics as defined by the infused volume (mL) at time of reported first sensation of filling. [Срок оценки: baseline, Week 4, and Week 8]
• Change in bladder sensation during urodynamics as defined by infused volume (mL) at time of reported urgency/ desire to void. [Срок оценки: Baseline, Week 4, and Week 8]
• Change in bladder sensation during urodynamics as defined by the infused volume (mL) at the time of reported discomfort. [Срок оценки: Baseline, Week 4, and Week 8]
• Change in detrusor compliance during urodynamics as reported by the change in bladder volume divided by the change in bladder pressure. [Срок оценки: baseline, Week 4, and Week 8]
• Change in the number of incontinence episodes as self-reported in the bladder diary. [Срок оценки: Baseline, Week 4, and Week 8]
• Change in the frequency of catheterization as self-reported in the bladder diary. [Срок оценки: Baseline, Week 4, and Week 8]

Критерии участия

Критерии включения

• Non-progressive chronic (>1 year) SCI
• Neurologic level of injury T9 and above
• Stable over active bladder (OAB) medications (≥3 months)
• No contraindication to MRI (per MRI Safety Questionnaire)
• English or Spanish speaking
• Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)
• Pass the tTNS competency checklist to perform or direct performance of tTNS.

Критерии исключения

• Ongoing/active genitourinary oncologic diagnoses
• History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy
• Pregnancy or planning to become pregnant.
• Lower Motor Neuron bladder
• Restorative bladder surgery such as augmentation cystoplasty
• Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)
• Anticoagulation treatment or prophylaxis
• Advanced peripheral vascular disease (gangrene, amputation, etc.)
• History of intolerance to electrical stimulation, particularly of the leg

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 at Houston — Houston

Идентификаторы

NCT: NCT07264868 · HSC-MS-25-0582 · CDMRP-SC240085

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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