Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Hemostasis time
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Understand and voluntarily sign an informed consent form.
- •Patients must be males with a prostate, at least 18 years of age
- •No prior prostate surgery
Exclusion Criteria
- •Unable/refuse to provide informed consent
- •Prior prostate surgery
- •Bladder stones that requiring lasering (small stone that can be removed whole is ok)
- •Unable to hold anticoagulants or antiplatelets per standard protocols for surgery and up to 1 week postop.
Arms & Interventions
Control - Holmium
Holmium laser enucleation
Intervention: holmium laser (Device)
Experimental - Thulio
Thulio laser enucleation
Intervention: pulsed thulium laser (Device)
Outcomes
Primary Outcomes
Hemostasis time
Time Frame: During surgery
time required to get adequate hemostasis intraoperatively
Secondary Outcomes
- Laser parameters(During surgery)
- Blood Loss(During surgery)
- Operative parameters(During surgery)
- Subjective laser performance(During surgery)
- Perioperative outcomes(30 days post op)
- Perioperative outcomes(0-5 days after surgey)
- Perioperative outcomes(0-5 days after surgery)
Investigators
Smita De
Principal Investigator
The Cleveland Clinic