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NCT Number: NCT07293442

Pelvic Floor Muscle Exercise for Lower Urinary Tract Symptoms After 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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 month–99 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University - Wan Fang Hospital, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Change in Postvoid Residual Volume (PVR)

    Time frame: Baseline, postoperative week 1, week 4, week 8

    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.

  2. Change in Urinary Incontinence Severity (ICIQ-UI Short Form)

    Time frame: Baseline, postoperative week 1, week 4, week 8

    Urinary incontinence severity is assessed using the ICIQ-UI Short Form questionnaire at baseline, postoperative week 1, week 4, and week 8.

  3. Change in Quality of Life (ICIQ-LUTSqol)

    Time frame: Baseline, postoperative week 1, week 4, week 8

    Quality of life is measured using the ICIQ-LUTSqol questionnaire at baseline, postoperative week 1, week 4, and week 8.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi-Chun Lin

CONTACT

[email protected]

+886-2-2930-7930 ext.58950

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

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.

Acronym: BPH LUTS PFME

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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