Pelvic floor therapy before prostate surgery to reduce urinary incontinence
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
NA · The Cleveland Clinic · NCT06179654
This study is testing whether starting pelvic floor therapy before prostate surgery can help reduce urinary incontinence afterwards for men undergoing the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | The Cleveland Clinic (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06179654 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of starting pelvic floor physical therapy (PFPT) before undergoing holmium laser enucleation of the prostate (HoLEP) surgery. The aim is to determine if preoperative PFPT can minimize the incidence and duration of stress urinary incontinence (SUI) that often follows HoLEP. Participants will engage in pelvic muscle exercises prior to surgery and continue therapy afterward to assess improvements in urinary continence. The study seeks to enhance patient outcomes and quality of life during recovery from BPH-related surgery.
Who should consider this trial
Good fit: Ideal candidates are adult males scheduled for HoLEP surgery due to benign prostatic hyperplasia and associated urinary symptoms.
Not a fit: Patients with neurological disorders affecting muscle function or specific urologic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time and incidence of urinary incontinence after prostate surgery, improving patient recovery and quality of life.
How similar studies have performed: While there is limited documentation on preoperative PFPT for HoLEP, similar approaches have shown promise in reducing SUI after radical prostatectomy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: \>=18 years of age 2. Sex: male sex assigned at birth (needs to have a prostate) 3. BMI: all BMI 4. Ethnic background: all ethnicities 5. Medical history: patients scheduled to undergo HoLEP for BPH/LUTS and associated complications (i.e. gross hematuria, retention, etc.). Exclusion Criteria: 1. Neurological disorders: patients with a history of a neurologic disorder that could affect muscle function, neurogenic bladder, lumbosacral spine pathology 2. Specific urologic conditions: patients with pre-operative indwelling catheter, urethral stricture greater than 1 centimeter in length or requiring dilation/incision, indwelling ureteral stent 3. History of pelvic radiation: patient with prior pelvic radiation will be excluded 4. Patients unable to give consent 5. Non-English speaking patients given the need for multiple surveys and telephone follow-ups.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Smita De
- Email: des@ccf.org
- Phone: 2163129460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention, Lower Urinary Tract Symptoms