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

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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07293442
Acronym
BPH LUTS PFME
Enrollment
46
Registered
2025-12-19
Start date
2025-12-19
Completion date
2026-07-31
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

LUTS, Quality of Life

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.

Interventions

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.

Sponsors

Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

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.

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
18 Months to 99 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in International Prostate Symptom Score (IPSS)Baseline, postoperative week 1, week 4, week 8Measures 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

MeasureTime frameDescription
Change in Postvoid Residual Volume (PVR)Baseline, postoperative week 1, week 4, week 8Postvoid 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.
Change in Urinary Incontinence Severity (ICIQ-UI Short Form)Baseline, postoperative week 1, week 4, week 8Urinary incontinence severity is assessed using the ICIQ-UI Short Form questionnaire at baseline, postoperative week 1, week 4, and week 8.
Change in Quality of Life (ICIQ-LUTSqol)Baseline, postoperative week 1, week 4, week 8Quality of life is measured using the ICIQ-LUTSqol questionnaire at baseline, postoperative week 1, week 4, and week 8.

Countries

Taiwan

Contacts

Primary ContactYi-Chun Lin
93322@w.tmu.edu.tw+886-2-2930-7930 ext.58950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026