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临床试验/NCT07293442
NCT07293442
招募中
不适用

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.

Taipei Medical University WanFang Hospital2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年12月19日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
46
试验地点
2
主要终点
Change in International Prostate Symptom Score (IPSS)

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Only the outcomes assessor was blinded. Participants and care providers could not be blinded due to the nature of the pelvic floor muscle exercise intervention.

入排标准

年龄范围
18 Months 至 99 Months(Child)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in International Prostate Symptom Score (IPSS)

时间窗: Baseline, postoperative week 1, week 4, week 8

Measures change in lower urinary tract symptoms using the International Prostate Symptom Score (IPSS). Participants complete the IPSS questionnaire at baseline (pre-surgery), and at postoperative week 1, week 4, and week 8.

次要结局

  • Change in Postvoid Residual Volume (PVR)(Baseline, postoperative week 1, week 4, week 8)
  • Change in Urinary Incontinence Severity (ICIQ-UI Short Form)(Baseline, postoperative week 1, week 4, week 8)
  • Change in Quality of Life (ICIQ-LUTSqol)(Baseline, postoperative week 1, week 4, week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Chun Lin

Principal Investigator

Taipei Medical University WanFang Hospital

研究点 (2)

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