Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate

NCT06179654 | Recruiting

• 1 other identifier: 23-1128
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to continence

  Time to recover from transient postoperative stress urinary incontinence

  6 months after surgery

Secondary Outcomes (8)

• Uroflow

  6 months after surgery

• Post void residual

  6 months after surgery

• international prostate symptom score

  6 months after surgery

• operative time

  day of surgery

• length of stay

  30 days after surgery

Study Arms (2)

Preoperative PFPT

EXPERIMENTAL

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

Behavioral: Preoperative pelvic floor physical therapy

Postoperative PFPT

NO INTERVENTION

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

Interventions

Preoperative pelvic floor physical therapy BEHAVIORAL

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

Preoperative PFPT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \>=18 years of age
• Sex: male sex assigned at birth (needs to have a prostate)
• BMI: all BMI
• Ethnic background: all ethnicities
• Medical history: patients scheduled to undergo HoLEP for BPH/LUTS and associated complications (i.e. gross hematuria, retention, etc.).

You may not qualify if:

• Neurological disorders: patients with a history of a neurologic disorder that could affect muscle function, neurogenic bladder, lumbosacral spine pathology
• Specific urologic conditions: patients with pre-operative indwelling catheter, urethral stricture greater than 1 centimeter in length or requiring dilation/incision, indwelling ureteral stent
• History of pelvic radiation: patient with prior pelvic radiation will be excluded
• Patients unable to give consent
• Non-English speaking patients given the need for multiple surveys and telephone follow-ups.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Urinary Retention; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Smita De

CONTACT

2163129460; des@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Urologist

Model Details: 2-cohort study. Group A will start pelvic floor exercises before surgery and Group B will start exercises after surgery.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 22, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)