Pelvic Floor Muscle Exercise for Lower Urinary Tract Symptoms After Surgery for Benign Prostatic Hyperplasia. (BPH LUTS PFME)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Behavioral: pelvic floor muscle exercises

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 Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Chun Lin; Phone Number: +886-2-2930-7930 ext.58950; Email: 93322@w.tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Wan Fang Hospital
    • Contact: YI-CHUN LIN; Phone Number: +886938022956; Email: 93322@w.tmu.edu.tw
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University - Wan Fang Hospital
    • Contact: Yi-Chun Lin; Phone Number: +886-2-2930-7930 ext.58950; Email: 93322@w.tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1：Intervention Group (Pelvic Floor Muscle Exercise Group); Participants in this group will receive a structured pelvic floor muscle exercise (PFME) program.The exercise program is administered after the baseline preoperative assessment and continues through postoperative week 1, week 4, and week 8 follow-up assessments.	Behavioral: 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 group. PFME aims to improve lower urinary tract symptoms, reduce postvoid residual volume, and enhance quality of life.
No Intervention: Arm 2：Control Group (Usual Care Group); Participants in this group will receive standard perioperative care without pelvic floor muscle exercise training. Baseline preoperative assessments and postoperative follow-ups at week 1, week 4, and week 8 will be conducted in the same schedule as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Prostate Symptom Score (IPSS)	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.	Baseline, postoperative week 1, week 4, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Postvoid Residual Volume (PVR)	Postvoid residual urine volume is measured using a non-invasive bladder scanner at baseline (pre-surgery), and at postoperative week 1, week 4, and week 8.	Baseline, postoperative week 1, week 4, week 8
Change in Urinary Incontinence Severity (ICIQ-UI Short Form)	Urinary incontinence severity is assessed using the ICIQ-UI Short Form questionnaire at baseline, postoperative week 1, week 4, and week 8.	Baseline, postoperative week 1, week 4, week 8
Change in Quality of Life (ICIQ-LUTSqol)	Quality of life is measured using the ICIQ-LUTSqol questionnaire at baseline, postoperative week 1, week 4, and week 8.	Baseline, postoperative week 1, week 4, week 8

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: LUTS, Quality of Life
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: N202511003; 113-WF-IR-10 (Other Grant/Funding Number: Wan Fang Hospital Holistic Care Project Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No