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

NCT06531473 | Recruiting

• 1 other identifier: STU00220458
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.

  Comparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups.

  2 years

Study Arms (3)

2J 40hz Laser Energy

EXPERIMENTAL

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

Procedure: HoLEP

2J 50hz Laser Energy

EXPERIMENTAL

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

Procedure: HoLEP

2J 60hz Laser Energy

EXPERIMENTAL

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

Procedure: HoLEP

Interventions

HoLEP PROCEDURE

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

2J 40hz Laser Energy; 2J 50hz Laser Energy; 2J 60hz Laser Energy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates

You may not qualify if:

• Prostates measurements over 200g
• Patients who lack decisional capacity
• Patients who are non-english speakers

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Amy Krambeck, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allaa Fadl-Alla, BS

CONTACT

312-724-3840; allaa.fadlalla@northwestern.edu

Alyssa McDonald, MS

CONTACT

312-724-3840; alyssa.mcdonald@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologic Surgeon

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: August 1, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)