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

Benign Prostatic Hyperplasia Clinical Trial

— HoLEP EAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566588
• Other study ID #: 145490
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: May 2022

Study information

• Verified date: September 2020
• Source: University of Kansas Medical Center
• Contact: Alexandra Dahlgren
• Phone: 913-574-0847
• Email: adahlgren[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Health System	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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