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

NCT04566588 | Completed

• 1 other identifier: 145490
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Post-operative Urinary Incontinence

  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

  Twelve Months Post-operative

Study Arms (2)

Early apical release holmium enucleation of the prostate

EXPERIMENTAL

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

Procedure: EAR HoLEP

Classic holmium enucleation of the prostate

ACTIVE COMPARATOR

Classic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia

Procedure: Classic HoLEP

Interventions

EAR HoLEP PROCEDURE

early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia

Early apical release holmium enucleation of the prostate

Classic HoLEP PROCEDURE

classic holmium enucleation of the prostate as a surgical treatment for benign prostatic hyperplasia

Classic holmium enucleation of the prostate

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: June 25, 2020
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)