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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 30, 2026 → Nov 30, 2026
See other at-risk trials from The Cleveland Clinic

Record History

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  1. Enrollment closed, study ongoing Show 6 more changesShow less
    • Primary completion pushed from Jun 30, 2026 to Nov 30, 2026
    • Study completion pushed from Oct 31, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description revised
    • Site details revised
  2. Primary completion date: Jun 30, 2025 to Jun 30, 2026
    • Study completion date: Oct 31, 2025 to Oct 31, 2026
    • Site contact updated
    v3
  3. Primary completion date: Nov 2024 to Jun 30, 2025
    • Study completion date: May 2025 to Oct 31, 2025
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06179654
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention, Lower Urinary Tract Symptoms
Related terms Lower Urinary Tract Symptoms, Urinary Retention
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov