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

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: Moses laser enucleation of prostate

• Registration Number: NCT04263987
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Results First Submitted: 2021-12-22
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-07
• Last Update Submitted: 2022-03-07
• Results First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at greater than 80 grams

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Exclusion Criteria

• Anyone actively on anticoagulation perioperatively

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moses Holmium Laser Enucleation of Prostate	Moses laser enucleation of prostate	holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
Holmium Laser Enucleation of Prostate	Moses laser enucleation of prostate	Traditional holmium laser enucleation of the prostate as currently performed

Primary Outcome Measures

Name	Time	Method
Operative Time	intraoperatively	time for surgery to take place

Secondary Outcome Measures

Name	Time	Method
Percentage of Change of Hematocrit	Baseline to postoperatively day 1	Blood loss is calculated by the percentage of change of hematocrit

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States