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

NCT06531473 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-11-14

No results posted yet for this study

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

Interventions

PROCEDURE

HoLEP

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

Sponsors & Collaborators

Principal Investigators

  • Amy Krambeck, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-08-30
Completion
2026-08-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531473 on ClinicalTrials.gov