Benign Prostatic Hypertrophy Requiring Surgical Intervention
Conditions
Brief summary
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).
Detailed description
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
Interventions
DEVICELumenis VersaCut Morcellator
DEVICEWolf Piranha Morcellator
Sponsors
Richard Wolf Medical Instruments Corporation (RWMIC)
Indiana Kidney Stone Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate. * Able to give informed consent. * Age 18 years or older
Exclusion criteria
* • Inability to give informed consent. * Age less than 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morcellation Rate | Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth | Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as morcellation rate. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lumenis VersaCut Morcellator Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation
Lumenis VersaCut Morcellator | 37 |
| Wolf Piranha Morcellator Wolf Piranha Morcellator will be utilized for prostate tissue morcellation
Wolf Piranha Morcellator | 37 |
| Total | 74 |
Baseline characteristics
| Characteristic | Wolf Piranha Morcellator | Total | Lumenis VersaCut Morcellator |
|---|---|---|---|
| Age, Continuous | 69 years | 68.5 years | 68 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 37 participants | 74 participants | 37 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 37 Participants | 74 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
Morcellation Rate
Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as morcellation rate.
Time frame: Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lumenis VersaCut Morcellator | Morcellation Rate | 4.8 grams/minute |
| Wolf Piranha Morcellator | Morcellation Rate | 5.6 grams/minute |