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

November 12, 2024 updated by: Amy Krambeck, Northwestern University

Laser Outcomes Associated With HoLEP Procedures

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine
        • Contact:
          • Alyssa McDonald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2J 40hz Laser Energy
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz
Procedure: HoLEP
Patients will be randomized to one of the laser energy groups day of surgery.
Experimental: 2J 50hz Laser Energy
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz
Procedure: HoLEP
Patients will be randomized to one of the laser energy groups day of surgery.
Experimental: 2J 60hz Laser Energy
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz
Procedure: HoLEP
Patients will be randomized to one of the laser energy groups day of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.
Time Frame: 2 years
Comparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Amy Krambeck, MD, Northwestern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00220458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urologic Diseases

Clinical Trials on HoLEP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe