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

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Northwestern University

Status

Enrolling

Conditions

Prostate Obstruction
Urologic Diseases

Treatments

Procedure: HoLEP

Study type

Interventional

Funder types

Other

Identifiers

NCT06531473
STU00220458

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Male

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

300 participants in 3 patient groups

2J 40hz Laser Energy
Experimental group
Description:
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz
Treatment:
Procedure: HoLEP
2J 50hz Laser Energy
Experimental group
Description:
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz
Treatment:
Procedure: HoLEP
2J 60hz Laser Energy
Experimental group
Description:
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz
Treatment:
Procedure: HoLEP

Trial contacts and locations

1

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Central trial contact

Allaa Fadl-Alla, BS; Alyssa McDonald, MS

Data sourced from clinicaltrials.gov

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