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

Laser Outcomes Associated With HoLEP Procedures

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531473
Enrollment
300
Registered
2024-08-01
Start date
2024-03-04
Completion date
2026-08-30
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urologic Diseases, Prostate Obstruction

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.

Interventions

PROCEDUREHoLEP

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

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.2 yearsComparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups.

Countries

United States

Contacts

Primary ContactAllaa Fadl-Alla, BS
allaa.fadlalla@northwestern.edu312-724-3840
Backup ContactAlyssa McDonald, MS
alyssa.mcdonald@northwestern.edu312-724-3840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026