Benign Prostatic Hyperplasia
Conditions
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.
Interventions
PROCEDUREMoses 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
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | intraoperatively | time for surgery to take place |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Change of Hematocrit | Baseline to postoperatively day 1 | Blood loss is calculated by the percentage of change of hematocrit |
Countries
United States
Participant flow
Recruitment details
VUMC 2019-2020
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Moses Holmium Laser Enucleation of Prostate | Total | Holmium Laser Enucleation of Prostate |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 60 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 6 | 69 years STANDARD_DEVIATION 7 | 70 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 50 Participants | 25 Participants |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 60 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 4 / 30 | 3 / 30 |
Outcome results
Primary
Operative Time
time for surgery to take place
Time frame: intraoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holmium Laser Enucleation of Prostate | Operative Time | 101 minutes | Standard Deviation 30 |
| Moses Holmium Laser Enucleation of Prostate | Operative Time | 126 minutes | Standard Deviation 22 |
Secondary
Percentage of Change of Hematocrit
Blood loss is calculated by the percentage of change of hematocrit
Time frame: Baseline to postoperatively day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Holmium Laser Enucleation of Prostate | Percentage of Change of Hematocrit | 6 percentage | Standard Deviation 4 |
| Moses Holmium Laser Enucleation of Prostate | Percentage of Change of Hematocrit | 9 percentage | Standard Deviation 4 |