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

NCT ID: NCT06531473

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2026-08-30

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.

Conditions

Urologic Diseases; Prostate Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

2J 40hz Laser Energy

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz

Group Type: EXPERIMENTAL

HoLEP

Intervention Type: PROCEDURE

Patients will be randomized to one of the laser energy groups day of surgery.

2J 50hz Laser Energy

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz

Group Type: EXPERIMENTAL

HoLEP

Intervention Type: PROCEDURE

Patients will be randomized to one of the laser energy groups day of surgery.

2J 60hz Laser Energy

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz

Group Type: EXPERIMENTAL

HoLEP

Intervention Type: PROCEDURE

Patients will be randomized to one of the laser energy groups day of surgery.

Interventions

HoLEP

Patients will be randomized to one of the laser energy groups day of surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amy Krambeck

Urologic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Krambeck, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Medicine

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Allaa Fadl-Alla, BS

Role: CONTACT

allaa.fadlalla@northwestern.edu

312-724-3840

Alyssa McDonald, MS

Role: CONTACT

alyssa.mcdonald@northwestern.edu

312-724-3840

Facility Contacts

Alyssa McDonald

Role: primary

Other Identifiers

STU00220458

Identifier Type: -

Identifier Source: org_study_id