Меню
Идёт набор NCT07293442

Pelvic Floor Muscle Exercise for Lower Urinary Tract Symptoms After Surgery for Benign Prostatic Hyperplasia.

Без фазы С лечением Benign Prostatic Hyperplasia

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: pelvic floor muscle exercises.
Кому может быть актуально
Состояния в реестре: Benign Prostatic Hyperplasia. Базовые параметры: 18 мес. — 99 мес. · 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Pelvic Floor Muscle Exercise on Lower Urinary Tract Symptoms, Postvoid Residual Volume and Quality of Life in Patients Undergoing Surgery for Benign Prostatic Hyperplasia.

Обзор

This study aims to evaluate the effectiveness of pelvic floor muscle exercise (PFME) on improving lower urinary tract symptoms (LUTS), postvoid residual volume (PVR), and quality of life in patients undergoing surgery for benign prostatic hyperplasia (BPH). Patients who undergo BPH-related procedures, such as TURP or HoLEP, often experience postoperative symptoms including urinary urgency, frequency, nocturia, dribbling, and voiding difficulty, which may negatively affect daily living. Pelvic floor muscle exercise is believed to enhance urethral sphincter function and pelvic floor support, thereby improving urinary control. This randomized study assigns participants to either an intervention group receiving PFME training or a control group receiving standard postoperative care. Differences in urinary outcomes between groups will be compared. The findings are expected to provide an accessible and cost-effective rehabilitation strategy to support postoperative recovery and quality of life.

Подробное описание

Patients undergoing surgery for Benign Prostatic Hyperplasia (BPH) frequently experience postoperative lower urinary tract symptoms (LUTS), voiding difficulties, urinary incontinence, and reduced quality of life. Pelvic Floor Muscle Exercise (PFME) has been shown to improve pelvic floor strength and urinary function; however, evidence regarding its effectiveness when applied as an early postoperative intervention remains limited. This study uses a pretest-posttest randomized design. All participants undergo baseline assessments before surgery, including LUTS questionnaires, postvoid residual measurement, and quality-of-life evaluation. After baseline assessment, participants are randomly assigned to either group using block randomization.

The intervention group receives standard postoperative care plus PFME training, which includes proper pelvic floor muscle contraction techniques, transversus abdominis coordination training, and the Knack maneuver. Training instruction and demonstrations are provided by the research team. The control group receives standard postoperative care and routine education only. Outcome assessments are conducted at 1 week, 4 weeks, and 8 weeks after surgery to evaluate the impact of PFME on LUTS, voiding function, and quality of life. This study aims to provide evidence for an effective early rehabilitation strategy to enhance postoperative urinary recovery and improve patients' quality of life.

Вмешательства

  • Поведенческое pelvic floor muscle exercises
    Participants assigned to the experimental arm will begin pelvic floor muscle exercises (PFME) before undergoing prostate surgery. The preoperative training includes instruction on correct pelvic floor muscle contraction techniques. After surgery, PFME is resumed one week post-operation when hematuria has resolved and continues for four weeks. Throughout the intervention period, participants receive regular guidance, exercise log monitoring, and support through a designated LINE communication gr

Первичные конечные точки

  • Change in International Prostate Symptom Score (IPSS) [Срок оценки: Baseline, postoperative week 1, week 4, week 8]
Вторичные конечные точки (3)
  • Change in Postvoid Residual Volume (PVR) [Срок оценки: Baseline, postoperative week 1, week 4, week 8]
  • Change in Urinary Incontinence Severity (ICIQ-UI Short Form) [Срок оценки: Baseline, postoperative week 1, week 4, week 8]
  • Change in Quality of Life (ICIQ-LUTSqol) [Срок оценки: Baseline, postoperative week 1, week 4, week 8]

Критерии участия

Критерии включения

  • Adults aged 18 years or older.
  • Diagnosed with benign prostatic hyperplasia (BPH) and scheduled to undergo their first prostate surgery.
  • Able to communicate in Mandarin or Taiwanese.

Критерии исключения

  • Patients with prostate cancer, bladder tumors, or other concomitant urological diseases.
  • Patients with long-term indwelling urinary catheters or suprapubic cystostomy.
  • Patients currently participating in other urology-related clinical trials.

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Тайвань · 2 центра
  • Taipei Medical University - Wan Fang Hospital — Taipei
  • Wan Fang Hospital — Taipei

Идентификаторы

NCT: NCT07293442 · N202511003 · 113-WF-IR-10

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗