Benign Prostatic Hypertrophy Requiring Surgical Intervention Clinical Trial
Official title:
Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH).
Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical
technique used for treatment of bladder outlet obstruction (BOO) secondary to benign
prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral
resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating
prostates of all sizes and has low perioperative morbidity.
A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect
the obstructing prostate tissue (enucleation). After enucleation is performed, the resected
tissue is advanced into the bladder. The morcellator is then used to cut the tissue into
small pieces which are then removed from the bladder via suction through the morcellator
blades (morcellation). We currently use the first commercially available morcellator
(VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope
(Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the
procedure.
Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany).
The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis
device
;