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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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BPH With Symptomatic Lower Urinary Tract Symptoms BPH With Urinary Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control - Holmium

Holmium laser enucleation

Group Type ACTIVE_COMPARATOR

holmium laser

Intervention Type DEVICE

Prostate enucleation will holmium laser (control)

Experimental - Thulio

Thulio laser enucleation

Group Type EXPERIMENTAL

pulsed thulium laser

Intervention Type DEVICE

experimental group - pulsed thulium laser prostate enucleation

Interventions

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holmium laser

Prostate enucleation will holmium laser (control)

Intervention Type DEVICE

pulsed thulium laser

experimental group - pulsed thulium laser prostate enucleation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes