Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate

Smita De

Status

Enrolling

Conditions

BPH With Urinary Obstruction

BPH With Symptomatic Lower Urinary Tract Symptoms

Treatments

Device: holmium laser

Device: pulsed thulium laser

Study type

Interventional

Funder types

Other

Identifiers

NCT07187180

25-209

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.