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NCT04263987 Clinical Trial

A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial

Benign Prostatic Hyperplasia Clinical Trial

Official title:
A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04263987
Other study ID # MOLEP Study
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 1, 2020
Est. completion date December 30, 2020

Study information
Verified date March 2022
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses Pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. We seek to evaluate Moses technology for enucleation of the prostate in the setting of BPH.

Description:

This is a single-center, prospective, double-blinded, randomized controlled trial comparing MOLEP to HOLEP. Inclusion criteria included all symptomatic BPH patients desiring enucleation with prostate sizes > 80ccs based on cross-sectional imaging. Patients are randomized in a 1:1 fashion and the study is powered to evaluate for a difference in operative time (i.e. alpha=0.05,N=21 per group). All surgeries will be performed with a 550 μm fiber. At the start of each case, a laser technician would be notified of randomization via envelope and randomize the settings to either Moses or traditional mode. The surgeons and patients were blinded to which mode was used. All surgeries will be performed using a two lobe technique and laser settings between 2J and 20-40Hz. Further recorded endpoints include change in blood loss, reduction in International Prostate Symptom Score (IPSS), improvement in uroflow parameters, and complications postoperatively at 6 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria: - Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at greater than 80 grams Exclusion Criteria: - Anyone actively on anticoagulation perioperatively

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Moses laser enucleation of prostate
Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operative Time time for surgery to take place intraoperatively
Secondary Percentage of Change of Hematocrit Blood loss is calculated by the percentage of change of hematocrit Baseline to postoperatively day 1
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