Actively Recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Led by The Cleveland Clinic · Updated on 2025-08-21
36
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether starting pelvic floor physical therapy (PFPT) before holmium laser enucleation of the prostate (HoLEP) surgery can reduce urinary incontinence after the procedure. The study focuses on men with benign prostatic hyperplasia (BPH) causing urinary symptoms and complications, a condition common in older men. HoLEP is a treatment for BPH with good outcomes but may lead to temporary stress urinary incontinence (SUI), which impacts quality of life. The study investigates if preoperative PFPT, combined with postoperative therapy, helps patients regain urinary control faster compared to starting therapy only after surgery. Participants are randomly assigned to one of two groups: one begins pelvic floor physical therapy one month before HoLEP surgery, continuing after surgery, and the other group starts therapy only after surgery, following standard care. The therapy consists of exercises targeting pelvic muscles to support urinary control. This randomized trial aims to clarify the role of preoperative PFPT in managing urinary leakage following HoLEP. During the study, researchers will measure the time it takes participants to regain continence within six months after surgery. Additional assessments include urine flow, residual urine after voiding, prostate symptom scores, surgery duration, hospital stay length, catheter use duration, infection rates, and emergency visits up to 30 days post-surgery. Participants will complete surveys and follow-ups to monitor progress and quality of life. The study is planned to conclude by October 2026.
CONDITIONS
Brief Title
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male sex assigned at birth with a prostate
- All BMI values allowed
- All ethnic backgrounds allowed
- Scheduled for HoLEP surgery to treat benign prostatic hyperplasia or related complications such as urinary retention or hematuria
You will not qualify if you...
- History of neurological disorders affecting muscle function or bladder control
- Presence of pre-operative indwelling catheter
- Urethral stricture longer than 1 centimeter or requiring treatment
- Presence of indwelling ureteral stent
- Prior pelvic radiation therapy
- Unable to provide informed consent
- Non-English speaking due to survey and follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month before surgery
Participants in the experimental group start pelvic floor physical therapy 1 month before surgery to help reduce stress urinary incontinence after surgery.
Weekly visits for up to 4 weeks
Duration - Day of surgery
Participants undergo Holmium Laser Enucleation of the Prostate (HoLEP) surgery.
1 visit (in-person)
Duration - Up to 6 months after surgery
Participants in the standard care group start pelvic floor physical therapy after surgery. Participants in the experimental group may continue therapy as per their assigned protocol.
Follow-up visits as scheduled for physical therapy
Duration - 6 months after surgery
Participants are monitored for continence, urinary function, and other outcomes up to 6 months after surgery to assess the effectiveness of pelvic floor physical therapy.
Periodic visits up to 6 months
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Smita De
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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