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Набор по приглашению NCT07534696

Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy

Без фазы С лечением Urinary Incontinence Prostatectomy

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: Non-invasive pelvic floor neuromuscular stimulation.
Кому может быть актуально
Состояния в реестре: Urinary Incontinence, Prostatectomy. Базовые параметры: от 18 лет · Мужчины.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Urinary incontinence is a common complication following prostatectomy and affects a substantial proportion of patients. Despite advances in surgical technique, many patients experience persistent symptoms that negatively impact quality of life. Current management strategies include pelvic floor muscle training, biofeedback and physical therapy, and surgical options. However, these approaches may be limited by adherence, access, and invasiveness, leaving a subset of patients with ongoing symptoms despite standard care. Non-invasive pelvic floor neuromuscular stimulation has emerged as a potential adjunct for pelvic floor rehabilitation by inducing supramaximal muscle contractions and enhancing neuromuscular activation without requiring active patient effort. Preliminary studies suggest that high-intensity electromagnetic stimulation may improve patient-reported continence outcomes and pad usage in women as well as men following radical prostatectomy, though existing data are limited by small sample sizes and short follow-up durations. Additionally, no clinical studies exist evaluating outcomes in men following prostatectomy prior to established stress incontinence. Given these limitations, further evaluation is needed to assess the feasibility, tolerability, and short-term effectiveness of this intervention in a post-prostatectomy population.

Подробное описание

This prospective study aims to evaluate feasibility, safety, and patient-reported continence outcomes associated with non-invasive pelvic floor neuromuscular stimulation in men with urinary incontinence following prostatectomy. Findings may inform future clinical implementation and guide the design of larger, controlled trials.

Вмешательства

  • Устройство Non-invasive pelvic floor neuromuscular stimulation
    Participants will complete an 8-week intervention (12 sessions total), with outcomes assessed at baseline, end of treatment, and follow-up within three months of starting the intervention.

Первичные конечные точки

  • Change in EPIC questionnaire score [Срок оценки: From enrollment to 3 months after initiation of treatment]
  • Change in ICIQ-UI questionnaire score [Срок оценки: From enrollment to 3 months after initiation of treatment]
  • Continence [Срок оценки: From enrollment to 3 months after initiation of treatment]
Вторичные конечные точки (1)
  • Treatment failure [Срок оценки: From enrollment to 3 months after initiation of treatment]

Критерии участия

Критерии включения

  • Men aged 18 years or older
  • Undergoing or underwent prostatectomy at UCLA
  • Able to provide informed consent

Критерии исключения

  • Cardiac pacemaker, implanted defibrillator, or other contraindicated metallic or electronic implants
  • Active urinary tract infection
  • Hematuria of unknown origin
  • Untreated bladder outlet obstruction
  • Neurologic conditions affecting bladder function (e.g., multiple sclerosis, Parkinson disease, spinal cord injury)
  • Active fever or systemic inflammatory condition at the time of treatment
  • Any condition deemed by the investigator to make participation unsafe

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UCLA The Men's Clinic — Santa Monica

Публикации

  • Tosun H, Akinsal EC, Bas U, Sonmez G, Baydilli N, Demirci D. Evaluating the Efficacy of High-Intensity Focused Electromagnetic (HIFEM) Therapy for Postprostatectomy Incontinence in Men. Ther Clin Risk Manag. 2025 Aug 30;21:1309-1315. doi: 10.2147/TCRM.S534674. eCollection 2025. PMID 40909763
  • Samuels JB, Pezzella A, Berenholz J, Alinsod R. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers Surg Med. 2019 Nov;51(9):760-766. doi: 10.1002/lsm.23106. Epub 2019 Jun 7. PMID 31172580

Идентификаторы

NCT: NCT07534696 · IRB #26-0324

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗