MedDataX Logo

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

NCT ID: NCT07293442

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostatic Hyperplasia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

LUTS, Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

pelvic floor muscle exercises

Intervention Type 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 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

99 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yi-Chun Lin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Medical University - Wan Fang Hospital

Taipei, , Taiwan

Site Status RECRUITING

Wan Fang Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yi-Chun Lin

Role: CONTACT

Phone: +886-2-2930-7930 ext.58950

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yi-Chun Lin

Role: primary

YI-CHUN LIN

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

113-WF-IR-10

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N202511003

Identifier Type: -

Identifier Source: org_study_id