A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Sponsor: Vanderbilt University Medical Center

Vanderbilt University Medical Center 
Department of Urologic Surgery 
 
 
 
 
 
 
 
 
Protocol  
Date: 4/4/2019 
 
NCT04263987 
 
Evaluation of the Moses Laser for Prostate 
Enucleation   
 
 
Nicholas Kavoussi, MD 
 
 
Clinical Instructor of Urologic Surgery 
Vanderbilt University Medical Center 
Department of Urologic Surgery 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Vanderbilt University Medical Center 
Department of Urologic Surgery 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Animal Studies and Previous Human Studies 
4.0 
Inclusion/Exclusion Criteria 
5.0 
Enrollment/Randomization 
6.0 
Study Procedures 
7.0 
Risks of Investigational Agents/Devices (side effects) 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
9.0 
Study Withdrawal/Discontinuation 
10.0 
Statistical Considerations 
11.0 
Privacy/Confidentiality Issues 
12.0 
Follow-up and Record Retention 
 
Appendices 
Appendix A Study Procedure Calendar 

Vanderbilt University Medical Center 
Department of Urologic Surgery 
 
 
 
1.0 
Background 
 
Benign prostatic hypertrophy (BPH) is common with almost 50% of men having 
pathologic changes in the prostate between 50 and 60 years old1. There are many 
options for the treatment of BPH, though a minimally invasive approach has been 
favorable over the past decade. Enucleation of a prostate with a laser has become a 
mainstay of BPH treatment and has shown to be safe and effective. Traditionally, a 
holmium laser is used for this (i.e. Holmium laser enucleation of the prostate or HoLEP), 
though recent new technologies have been developed to improve laser surgery. One 
example is the Moses laser fiber produced by Lumenis (Yokneam, Israel), which alters 
laser pulse wave characteristics to improve the efficiency of energy delivery to a target. 
The technology is hypothesized to lead to better improvements in operative time and 
hemostasis 2,3,4. Though the technology has been proven to be safe in human use, it has 
not been formally evaluated for prostatic enucleation.   We seek to compare HoLEP to 
Moses laser enucleation of the prostate (i.e. MoLEP) for the treatment of BPH.  
 
1. Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign 
prostatic hyperplasia with age. J urol 1084; 132(3):474-479. 
2. Elhilali M., Badaan S., Ibrahim A., Andonian S. Use of Moses Pulse Modulation 
Technology to Improve Holmium Laser Lithotripsy Outcomes: A preclinical study. 
Journal of Endourology (June, 2017) 
3. Mark Cynk, Holmium Laser Enucleation of the Prostate is More Efficient with 
More Laser Power, abstract #MP7- 01, Moderated Poster Session 7: BPH/LUTS, 
WCE 2016 
4. Beaghler M, Leo M, Gass J, March J, Sandoval S, et al. (2017) Initial Experience 
with New High Powered 120 W Holmium for Vaporization of the Prostate. Urol 
Nephrol Open Access J 4(2): 00119. DOI: 10.15406/ unoaj.2017.04.00119 
 
 
2.0 
Rationale and Specific Aims 
 
The aims of this study are to: 
1. Evaluate Moses laser technology for prostatic enucleation compared to 
traditional holmium laser enucleation. 
2. Determine changes in blood loss, operative times, and quality of life 
improvements between the two technologies.  
 
3.0 
Animal Studies and Previous Human Studies 
 
There are no previously published articles examining animal studies related to Moses 
fiber enucleation of the prostate.  Currently, laser enucleation of the prostate with 
standard holmium or thulium lasers is routinely performed for BPH.  Though Moses 
technology operates similar to other lasers on the market and has been shown to be 
safe in humans, it has not been evaluated for surgical outcomes. 
 
 

Vanderbilt University Medical Center 
Department of Urologic Surgery 
 
 
 
4.0 
Inclusion/Exclusion Criteria 
 
• 
Exclusion criteria 
1. Pediatric patients (<18 years old) 
2. Abnormal anatomy precluding enucleation 
• 
Inclusion 
1. Patients with planned prostatic enucleation for BPH. 
 
 
5.0 
Enrollment/Randomization 
 
We will identify patients scheduled to undergo laser enucleation of the prostate for BPH 
through our urology clinic.  Power analysis to detect a 50% change in blood loss (i.e. a 
change in hemoglobin level) will lead to approximately 20 patients in each group. A 
random number generator will be used at the beginning of each case after the induction 
of anesthesia to randomize patients to MoLEP or HoLEP. 
 
6.0 
Study Procedures 
 
Patients will be consented in our clinic after being scheduled for surgery.  All patients will 
fill out voiding symptom scores (i.e. International Prostate Symptom Scores(IPSS)), 
erectile dysfunction symptom scores (i.e. Sexual Health Inventory for Men(SHIM)) and 
have a preoperative urine flow, postvoid volume and a prostate specific antigen (PSA) 
recorded.  Intraoperatively, total surgery time, as well as enucleation and morcellation 
times, will be recorded. Furthermore, intraoperative blood loss and surgical 
complications will be evaluated.  Postoperatively, all patients will be observed overnight 
in the hospital with a urethral catheter. Routine labs will be sent including a complete 
blood count and metabolic panel.    Postoperative day one, all patients will undergo a 
voiding trial for catheter removal.  Patients will be monitored for routine complications 
after HoLEP such as urinary retention, urosepsis, urinary leakage. Other variables to be 
recorded will be age, sex, size of prostate, BMI, anticoagulation status, and other 
comorbidities.  Patients will follow up at 4 weeks for a postoperative check and 
evaluation of symptoms (i.e. IPSS, SHIM, flow rate, postvoid residual volume and PSA). 
  
7.0 
Risks 
 
The risks include all those that come with undergoing prostatic enucleation.  That 
includes: urinary tract infection (<5%), urinary leakage (<5%), bleeding(<2%).  
 
  
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
 
Any adverse events or anticipated problems will be reported to the IRB by the PI within 5 
business days of the discovery. 
 
 
9.0 
Study Withdrawal/Discontinuation 
 

Vanderbilt University Medical Center 
Department of Urologic Surgery 
 
 
 
Subjects would be withdrawn from the study if their anatomy complicates the assigned 
prostate surgery or intraoperatively, access is unobtainable in a retrograde fashion.  
Subjects may withdraw from the study at any time. 
 
10.0 
Privacy/Confidentiality Issues 
Any information obtained will remain confidential and patient records will be de-
identified.  All information will be stored in password encrypted files.  The results of the 
project may be made public and information published in profession journals, but no 
identifying information will be published. 
 
11.0 
Follow-up and Record Retention 
 
It is anticipated the data collection will take 12 months to complete, and another 12 
months to analyze the data.  All identifiers will be destroyed 4 years after the study 
initiation, or 2 years after data collection is complete, whichever is sooner.