Trial Outcomes & Findings for 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 (NCT NCT04263987)
NCT ID: NCT04263987
Last Updated: 2022-03-31
Results Overview
time for surgery to take place
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
intraoperatively
Results posted on
2022-03-31
Participant Flow
VUMC 2019-2020
Participant milestones
| Measure |
Holmium Laser Enucleation of Prostate
Traditional holmium laser enucleation of the prostate as currently performed
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
|
Moses Holmium Laser Enucleation of Prostate
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
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
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Holmium Laser Enucleation of Prostate
n=30 Participants
Traditional holmium laser enucleation of the prostate as currently performed
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
|
Moses Holmium Laser Enucleation of Prostate
n=30 Participants
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
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
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 8 • n=99 Participants
|
68 years
STANDARD_DEVIATION 6 • n=107 Participants
|
69 years
STANDARD_DEVIATION 7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: intraoperativelytime for surgery to take place
Outcome measures
| Measure |
Holmium Laser Enucleation of Prostate
n=30 Participants
Traditional holmium laser enucleation of the prostate as currently performed
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
|
Moses Holmium Laser Enucleation of Prostate
n=30 Participants
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
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
|
101 minutes
Standard Deviation 30
|
126 minutes
Standard Deviation 22
|
SECONDARY outcome
Timeframe: Baseline to postoperatively day 1Blood loss is calculated by the percentage of change of hematocrit
Outcome measures
| Measure |
Holmium Laser Enucleation of Prostate
n=30 Participants
Traditional holmium laser enucleation of the prostate as currently performed
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
|
Moses Holmium Laser Enucleation of Prostate
n=30 Participants
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
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
|
|---|---|---|
|
Percentage of Change of Hematocrit
|
6 percentage
Standard Deviation 4
|
9 percentage
Standard Deviation 4
|
Adverse Events
Holmium Laser Enucleation of Prostate
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Moses Holmium Laser Enucleation of Prostate
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Holmium Laser Enucleation of Prostate
n=30 participants at risk
Traditional holmium laser enucleation of the prostate as currently performed
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
|
Moses Holmium Laser Enucleation of Prostate
n=30 participants at risk
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
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
|
|---|---|---|
|
Renal and urinary disorders
cystitis
|
13.3%
4/30 • Number of events 4 • Up to 6 weeks postoperatively
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
10.0%
3/30 • Number of events 3 • Up to 6 weeks postoperatively
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place