A Phase 3 interventional study of Moses laser enucleation of prostate in Benign Prostatic Hyperplasia, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to male participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Vanderbilt University Medical Center · Phase 3, Interventional, and Treatment
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.
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.
803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 60 is below the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 159 are open to participants now.
Of its 124 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
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Exclusion Criteria:
Traditional holmium laser enucleation of the prostate as currently performed
Procedure: Moses laser enucleation of prostate
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
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
Operative Time
time for surgery to take place
Time frame: intraoperatively
Percentage of Change of Hematocrit
Blood loss is calculated by the percentage of change of hematocrit
Time frame: Baseline to postoperatively day 1
VUMC 2019-2020
| Milestone | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
time for surgery to take place
| minutes | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate |
|---|---|---|
| Operative Time | 101 ± 30 | 126 ± 22 |
Blood loss is calculated by the percentage of change of hematocrit
| percentage | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate |
|---|---|---|
| Percentage of Change of Hematocrit | 6 ± 4 | 9 ± 4 |
Collected over Up to 6 weeks postoperatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Holmium Laser Enucleation of Prostate | 0/30 (0%) | 4/30 (13.3%) | 0/30 (0%) |
| Moses Holmium Laser Enucleation of Prostate | 0/30 (0%) | 3/30 (10%) | 0/30 (0%) |
| Event | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate |
|---|---|---|
| cystitisRenal and urinary disorders | 4/30 | 3/30 |
men with benign prostatic hypertrophy (BPH)
| Age, Categorical(Participants) | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 30 | 30 | 60 |
| Age, Continuous(years) | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate | Total |
|---|---|---|---|
| Mean | 70 ± 8 | 68 ± 6 | 69 ± 7 |
| Sex: Female, Male(Participants) | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 30 | 30 | 60 |
| Race (NIH/OMB)(Participants) | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 25 | 25 | 50 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Holmium Laser Enucleation of Prostate | Moses Holmium Laser Enucleation of Prostate | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
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