Many consider laser enucleation of the prostate the new 'gold standard' for the surgical treatment of benign prostatic hyperplasia (BPH) due to its excellent outcomes, high success rates, and long-term efficacy. Holmium laser enucleation of the prostate (HoLEP) was the earliest form of prostate enucleation and is recommended by the American Urological Association (AUA), along with thulium laser enucleation of the prostate (ThuLEP), as size-independent techniques for the management of BPH with fewer complications than transurethral resection of the prostate (TURP). Further development of laser technology has additionally led to enucleation using pulsed-modulated (e.g. "Virtual Basket™" mode or MOSES™ mode) holmium lasers as well as the thulium fiber laser.
Study Design This is a prospective randomized study to evaluate the differences in outcomes comparing the existing laser to a new laser among patients undergoing HoLEP. Patients will be evaluated prior to the procedure and at one follow-up time point. Patients will be randomized in equal numbers to each group. The primary outcome will be non-inferiority in hemostasis timing. Several secondary outcomes will be evaluated including enucleation time, active laser time, morcellation time, prostate volume, change in hemoglobin, applied total laser energy, enucleation efficacy (g/min), IPSS (International Prostate Symptom Score), QoL (Quality of Life), uroflowmetry, PVR (post-void residual), duration of catheterization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Prostate enucleation will holmium laser (control)
experimental group - pulsed thulium laser prostate enucleation
Cleveland Clinic Main
Cleveland, Ohio, United States
RECRUITINGHemostasis time
time required to get adequate hemostasis intraoperatively
Time frame: During surgery
Blood Loss
Estimated blood loss (mL)
Time frame: During surgery
Blood Loss
Change in hemoglobin (delta g/dL)
Time frame: During surgery
Operative parameters
Enucleation time (minutes)
Time frame: During surgery
Operative parameters
morcellation time (minutes)
Time frame: During surgery
Operative parameters
enucleation efficiency (mL prostate)
Time frame: During surgery
Laser parameters
Laser time (minutes)
Time frame: During surgery
Laser parameters
laser energy (joules)
Time frame: During surgery
Laser parameters
Fiber burn-back (cm)
Time frame: During surgery
Subjective laser performance
Surgeon estimation of collateral tissue injury and overall performance (scale 1 minimum 10 maximum)
Time frame: During surgery
Perioperative outcomes
volume of tissue removed (mL)
Time frame: 0-5 days after surgey
Perioperative outcomes
catheter time (hours)
Time frame: 0-5 days after surgery
Perioperative outcomes
length of stay (hours)
Time frame: 0-5 days after surgery
Perioperative outcomes
operative complications
Time frame: 30 days post op
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