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NCT Number: NCT06531473

Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) 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.

Recruiting

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Key information

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Alyssa McDonald

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holep

Procedure

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allaa Fadl-Alla, BS

CONTACT

[email protected]

312-724-3840

Alyssa McDonald, MS

CONTACT

[email protected]

312-724-3840

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Laser Outcomes Associated With HoLEP Procedures

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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