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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06531473
Status
Recruiting
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Conditions

  • Prostate Obstruction
  • Urologic Diseases

Eligibility Criteria

Sex
MALE
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • HoLEP — PROCEDURE
    Patients will be randomized to one of the laser energy groups day of surgery.

Study Details

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.

Key Dates

Start date
Mar 4, 2024
Status verified
Nov 2024
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 2J 40hz Laser Energy
    Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz
  • Experimental: 2J 50hz Laser Energy
    Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz
  • Experimental: 2J 60hz Laser Energy
    Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz

Primary Outcome Measure

Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate. [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern MedicineChicagoIllinois60611
Alyssa McDonald

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By research site
Northwestern Medicine· Chicago, IL

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