Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: Classic HoLEP; Procedure: EAR HoLEP

• Registration Number: NCT04566588
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

To determine if early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia, reduces post-operative urinary incontinence compared to classic HoLEP.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-25
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Primary Completion: 2021-05-11
• Study Completion: 2021-05-11
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Patients must be 18 years of age or older
• Patients must present to clinic with a diagnosis of benign prostatic hyperplasia
• Patients must be scheduled to undergo a holmium laser enucleation of the prostate

Exclusion Criteria

• Patients with previous surgical management of BPH
• Patients with prostate biopsy revealing high risk prostate cancer
• Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic holmium enucleation of the prostate	Classic HoLEP	Classic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia
Early apical release holmium enucleation of the prostate	EAR HoLEP	Early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia

Primary Outcome Measures

Name	Time	Method
Post-operative Urinary Incontinence	Twelve Months Post-operative	to determine if patients who undergo early apical release HoLEP have reduced rates of post-operative urinary incontinence compared to classic HoLEP as measured by patient report of leakage

Trial Locations

Locations (1)

University of Kansas Health System; 🇺🇸 Kansas City, Kansas, United States