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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Holmium Laser Enucleation of Prostate | Active Comparator | Traditional holmium laser enucleation of the prostate as currently performed |
|
| Moses Holmium Laser Enucleation of Prostate | Experimental | holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moses laser enucleation of prostate | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | time for surgery to take place | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Change of Hematocrit | Blood loss is calculated by the percentage of change of hematocrit | Baseline to postoperatively day 1 |
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Inclusion Criteria:
Exclusion Criteria:
For prostatic disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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VUMC 2019-2020
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2019 | Feb 7, 2022 |
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| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
men with benign prostatic hypertrophy (BPH)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Operative Time | time for surgery to take place | Posted | Mean | Standard Deviation | minutes | intraoperatively |
|
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| |||||||||||||||||||||||||||||
| Secondary | Percentage of Change of Hematocrit | Blood loss is calculated by the percentage of change of hematocrit | Posted | Mean | Standard Deviation | percentage | Baseline to postoperatively day 1 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 30 | 4 | 30 | 0 | 30 |
| EG001 | 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 | 0 | 30 | 3 | 30 | 0 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cystitis | Renal and urinary disorders | Systematic Assessment | cystitis postoperatively, resolved with antibiotics |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas kavoussi | Vanderbilt University Medical Center | 615-322-7401 | nicholas.l.kavoussi@vumc.org |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2021 | Feb 7, 2022 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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