Patients will be evaluated preoperatively per standard of care in urology clinic. We will
obtain American Urological Association Symptom Score (AUA-SS) and Quality of Life (QoL)
assessment as well as post-void residual bladder scan (PVR), and prostate specific
antigen (PSA). All of these assessments will be part of standard of care.
Based on the current coronavirus (COVID-19) pandemic and the changing health landscape
with increased emphasis on telehealth, patient may be offered virtual appointments for
aspects of the trial that do not require in-person evaluation or testing. These include
but are not limited to inclusion/exclusion criteria evaluation, consent for trial
participation, or survey completion.
Patients will be taken to the operating room per standard of care. They will be
randomized to either Holmium Laser Vaporization of Prostate (HoLVP) with or without the
use of Moses 2.0 technology. The surgeon and patient will both be blinded to the laser
mode.
HoLVP will occur in standard fashion thereafter utilizing at 550-micron holmium Xpeeda
side fire laser fiber at settings of 2 Joules, 50 Hertz. Moses 2.0 will be activated or
not by operating room personnel based on patient's randomization status. Again, the
surgeon and assistant will not be informed of the Moses status.
Intraoperative parameters will be recorded including total procedure time, total
vaporization time, vaporization efficiency (g/min), and total energy used. Surgeons will
evaluate tissue char, visibility, hemostasis, as well as select if they think Moses 2.0
was activated or not for the procedure.
Timeline for catheter removal will be per surgeon discretion with a general plan for
removal in the post-anesthesia care unit with trial of void before discharge on day of
surgery. If patient is discharged with a catheter in place, removal date will be
determined per surgeon's discretion.
Patients will be seen in urology clinic for follow up per standard of care at 6 weeks, 3
months, and 12 months post operatively at which time we will obtain symptom
questionnaires. A PVR will be obtained at 6 weeks. PSA will be measured at 3 months post
operatively, to act as a surrogate marker for percentage of tissue vaporized since it can
be compared to pre-operative PSA.
Outcomes from surgery will be assessed including changing in AUA-SS and QoL, and PVR. We
will also evaluate for complications such as urethral stricture, bladder neck
contracture, and need for re-operation.
