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

NCT07187180 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • BPH With Symptomatic Lower Urinary Tract Symptoms
  • BPH With Urinary Obstruction

Interventions

DEVICE

holmium laser

Prostate enucleation will holmium laser (control)

DEVICE

pulsed thulium laser

experimental group - pulsed thulium laser prostate enucleation

Sponsors & Collaborators

  • Smita De

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-06-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07187180 on ClinicalTrials.gov