Benign Prostatic HyperplasiaBPH LUTS PFMENCT07293442
Pelvic Floor Muscle Exercise for Lower Urinary Tract Symptoms After Surgery for Benign Prostatic Hyperplasia.
A study testing pelvic floor muscle exercises in people with Benign Prostatic Hyperplasia, run by Taipei Medical University WanFang Hospital at 2 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 months, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- pelvic floor muscle exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesTaiwan
- Study dates
- 19 Dec 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University - Wan Fang Hospital
Taipei
Yi-Chun Lin, +886-2-2930-7930 ext.58950, 93322@w.tmu.edu.tw
- Recruiting
Wan Fang Hospital
Taipei
YI-CHUN LIN, +886938022956, 93322@w.tmu.edu.tw
About this study
Official 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.
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- pelvic floor muscle exercises
- Keywords
- LUTS, Quality of Life
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor muscle exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, postoperative week 1, week 4, week 8
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, postoperative week 1, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start19 Dec 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Chun Lin, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293442
- Sponsor's protocol ID
- N202511003
- Other IDs
- 113-WF-IR-10
- Acronym
- BPH LUTS PFME
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07293442
- Acronym / sponsor ID
- BPH LUTS PFME / N202511003
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- LUTS, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1：Intervention Group (Pelvic Floor Muscle Exercise Group) | Experimental | Behavioral: pelvic floor muscle exercisesParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic floor muscle exercisesParticipants 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. | Behavioural | Arm 1：Intervention Group (Pelvic Floor Muscle Exercise Group) |
Primary outcome
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.
3 secondary outcomes
Change in Postvoid Residual Volume (PVR)
Time frame: Baseline, postoperative week 1, week 4, week 8
Change in Urinary Incontinence Severity (ICIQ-UI Short Form)
Time frame: Baseline, postoperative week 1, week 4, week 8
Change in Quality of Life (ICIQ-LUTSqol)
Time frame: Baseline, postoperative week 1, week 4, week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor muscle exercises in people with Benign Prostatic Hyperplasia, run by Taipei Medical University WanFang Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chun Lin (+886-2-2930-7930 ext.58950, 93322@w.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Baseline, postoperative week 1, week 4, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.