Recruiting

Pelvic Floor Physical Therapy

Sponsor:

The Cleveland Clinic

Code:

NCT06179654

Conditions

Benign Prostatic Hyperplasia With Outflow Obstruction

Urinary Retention

Lower Urinary Tract Symptoms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Preoperative pelvic floor physical therapy

Study Details

Brief summary:

The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.

Conditions

Benign Prostatic Hyperplasia With Outflow Obstruction

Urinary Retention

Lower Urinary Tract Symptoms

Study ID

NCT06179654

Start date

Nov 29, 2023

Status verified date

Aug, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Preoperative PFPT

This group of patients will be instructed to start pelvic floor physical therapy 1 month before surgery.

no intervention: Postoperative PFPT

This group of patients will be instructed to start pelvic floor physical therapy after surgery (standard of care).

Interventions

Preoperative pelvic floor physical therapy

Pelvic floor physical therapy to start before prostate surgery rather than after surgery.

Primary outcome measure

  • Time to continence [ Time Frame: 6 months after surgery ]

Central Contacts and Locations

Central contacts

Smita De

2163129460des@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Smita Clinic

2163129460des@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-08-21.