Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures

Not Applicable

Recruiting

• Conditions: Prostate Obstruction; Urologic Diseases
• Interventions: Procedure: HoLEP

• Registration Number: NCT06531473
• Lead Sponsor: Northwestern University

Brief Summary

The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate. There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2j 50hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as \> 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as \>10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

• Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates

Exclusion Criteria

• Prostates measurements over 200g
• Patients who lack decisional capacity
• Patients who are non-english speakers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2J 40hz Laser Energy	HoLEP	Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz
2J 60hz Laser Energy	HoLEP	Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz
2J 50hz Laser Energy	HoLEP	Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz

Primary Outcome Measures

Name	Time	Method
Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.	2 years	Comparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups.

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States