Back to resultsA 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
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Moses laser enucleation of prostate
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Holmium Laser Enucleation of Prostate
Moses Holmium Laser Enucleation of Prostate
Arm Description
Traditional holmium laser enucleation of the prostate as currently performed
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
Outcomes
Primary Outcome Measures
Operative Time
time for surgery to take place
Secondary Outcome Measures
Percentage of Change of Hematocrit
Blood loss is calculated by the percentage of change of hematocrit
Full Information
NCT ID
NCT04263987
First Posted
February 7, 2020
Last Updated
March 7, 2022
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04263987
Brief Title
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
Official Title
A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Holmium Laser Enucleation of Prostate
Arm Type
Active Comparator
Arm Description
Traditional holmium laser enucleation of the prostate as currently performed
Arm Title
Moses Holmium Laser Enucleation of Prostate
Arm Type
Experimental
Arm Description
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
Intervention Type
Procedure
Intervention Name(s)
Moses laser enucleation of prostate
Intervention Description
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
Primary Outcome Measure Information:
Title
Operative Time
Description
time for surgery to take place
Time Frame
intraoperatively
Secondary Outcome Measure Information:
Title
Percentage of Change of Hematocrit
Description
Blood loss is calculated by the percentage of change of hematocrit
Time Frame
Baseline to postoperatively day 1
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
For prostatic disease
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this 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
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