Tibial Nerve Stimulation for Post-BPH Overactive Bladder

Официальное название

Study on the Efficacy of Wearable Transcutaneous Tibial Nerve Stimulation for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery

Обзор

A single-center, randomized, parallel-controlled design. Approximately 90 cases of persistent overactive bladder symptoms post benign prostatic hyperplasia surgery are expected to be enrolled. The study participants will be randomly assigned to three groups, with 30 participants in each group.

Вмешательства

• Устройство Transcutaneous Tibial Nerve Stimulation(TTNS)
  Participants in this group will discontinue all relevant medications (e.g., β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs) at least 14 days before signing the informed consent and will not use these medications during the study period. They will receive treatment solely with wearable transcutaneous tibial nerve stimulation.
• Комбинированный продукт Combination Therapy
  Participants in this group will continue their prescribed medication regimen, which may include β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs, with dosages and administration unchanged throughout the study. In addition to the standard medication therapy, participants will receive wearable transcutaneous tibial nerve stimulation using a wearable device
• Препарат Standard Medication Therapy
  Participants in this group will maintain their usual medication regimen, which may include β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs, with dosages and administration remaining consistent throughout the study. No additional interventions will be provided.

Первичные конечные точки

• Average Daily Urination Frequency Compared to Baseline [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]

Вторичные конечные точки (10)

• Average Urinary Urgency Score [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• Average Daily Nocturia Frequency Compared to Baseline [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• Average Voided Volume per Urination Compared to Baseline [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• Average Daily Incontinence Episodes [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• OABSS Compared to Baseline [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• PPBC-S Compared to Baseline [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• AUA-SI-QOL Compared to Baseline [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• SAS Compared to Baseline [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• Participant Satisfaction [Срок оценки: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
• Potential Adverse Events Related by TTNS [Срок оценки: Entire Study]

Критерии участия

Критерии включения

• 1\. Patients with overactive bladder before benign prostatic hyperplasia 2.Overactive bladder still exists 1 month after the operation of benign prostatic hyperplasia; 3.50 ≤ age ≤80 , male 4.72-hour urination diary showed an average of ≥8 urination times every 24 hours at baseline

Критерии исключения

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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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06558539 · TTNS2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗