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Recruiting NCT07187180

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

No phase Interventional BPH With Symptomatic Lower Urinary Tract Symptoms BPH With Urinary Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: holmium laser, pulsed thulium laser.
Who it may be relevant to
Registry conditions: BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device holmium laser
    Prostate enucleation will holmium laser (control)
  • Device pulsed thulium laser
    experimental group - pulsed thulium laser prostate enucleation

Primary outcome measures

  • Hemostasis time [Time frame: During surgery]
Secondary outcome measures (12)
  • Blood Loss [Time frame: During surgery]
  • Blood Loss [Time frame: During surgery]
  • Operative parameters [Time frame: During surgery]
  • Operative parameters [Time frame: During surgery]
  • Operative parameters [Time frame: During surgery]
  • Laser parameters [Time frame: During surgery]
  • Laser parameters [Time frame: During surgery]
  • Laser parameters [Time frame: During surgery]
  • Subjective laser performance [Time frame: During surgery]
  • Perioperative outcomes [Time frame: 0-5 days after surgey]
  • Perioperative outcomes [Time frame: 0-5 days after surgery]
  • Perioperative outcomes [Time frame: 0-5 days after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cleveland Clinic Main — Cleveland

Identifiers

NCT: NCT07187180 · 25-209

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗