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

NCT07293442 | Recruiting

• 2 other identifiers: N202511003113-WF-IR-10
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

LUTS, Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Arm 1：Intervention Group (Pelvic Floor Muscle Exercise Group)

EXPERIMENTAL

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

Arm 2：Control Group (Usual Care Group)

NO INTERVENTION

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.

Interventions

pelvic floor muscle exercises BEHAVIORAL

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.

Arm 1：Intervention Group (Pelvic Floor Muscle Exercise Group)

Eligibility Criteria

• Age: 18 Months - 99 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (2)

Taipei Medical University - Wan Fang Hospital

Taipei, Taiwan

RECRUITING

Wan Fang Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Yi-Chun Lin

CONTACT

+886-2-2930-7930 ext.58950; 93322@w.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a single-blind, parallel-group, randomized controlled trial. Participants will complete a baseline (preoperative) assessment before surgery. After the baseline assessment, participants will be randomly assigned to either the intervention group or the control group. Outcome assessments will be conducted at postoperative week 1, week 4, and week 8. The study evaluates the effects of pelvic floor muscle exercise on lower urinary tract symptoms, postvoid residual volume, and quality of life following surgery for benign prostatic hyperplasia.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)