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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Change in International Prostate Symptom Score (IPSS)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Months to 99 Months (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in International Prostate Symptom Score (IPSS)
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Yi-Chun Lin
Principal Investigator
Taipei Medical University WanFang Hospital