Идёт набор NCT06740071

The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy

Без фазы С лечением Prostate Cancer (Post 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: somatosensory interactive pelvic floor muscle training, pelvic floor magnetic stimulation therapy, standard pelvic floor muscle training.
Кому может быть актуально: Состояния в реестре: Prostate Cancer (Post Prostatectomy). Базовые параметры: 18 лет — 85 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: Китай, Гонконг
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). The methods being compared include standard PFMT (S-PFMT) , a somatosensory interactive PFMT (SI-PFMT, an enhanced PFMT) , and a standard PFMT combined with pelvic floor muscle magnetic stimulation (S-PFMT+MS). Eligible participants are randomized into either of the groups to receive different modalities of post-operative PFMT. Subjects in the S-PFMT group received traditional verbal instructions and paper-based educational materials. For the SI-PFMT group, an interactive experiential education model was adopted. First, an educational video introduced the importance and basic information of postoperative PFMT. Then, synchronized PFMT guidance through a combination of audio and video would be used. Subjects assigned to the S-PFMT+MS group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician. Self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.

Вмешательства

Поведенческое somatosensory interactive pelvic floor muscle training
synchronized PFMT guidance through a combination of audio and video
Процедура pelvic floor magnetic stimulation therapy
stimulation frequency was set at 10 Hz, with stimulation administered in cycles of 5 seconds on followed by 5 seconds off. Each treatment session lasted 20 minutes, conducted twice a week, for a total of 10-12 sessions
Поведенческое standard pelvic floor muscle training
traditional verbal instructions and paper-based educational materials of PFMT are given to participants. All patients would receive PFMT under the guidance of digital rectal examination by nurses, and their pelvic floor muscle function was graded according to the Oxford Grading System (grades 0-5), ensuring the correctness of subsequent PFMT.

Первичные конечные точки

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [Срок оценки: 1, 3, and 6 months postoperatively.]

Вторичные конечные точки (1)

urine leakage volume from the 1-hour pad test [Срок оценки: 1, 3, and 6 months postoperatively]

Критерии участия

Критерии включения

PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)

Критерии исключения

patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors

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

Здоровые добровольцы: Нет