Recruiting

Laser Enucleation

Sponsor:

Smita De

Code:

NCT07187180

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

BPH With Urinary Obstruction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

holmium laser

pulsed thulium laser

Study Details

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.

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

BPH With Urinary Obstruction

Study ID

NCT07187180

Start date

Jun 2, 2025

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control - Holmium

Holmium laser enucleation

experimental: Experimental - Thulio

Thulio laser enucleation

Interventions

holmium laser

Prostate enucleation will holmium laser (control)

pulsed thulium laser

experimental group - pulsed thulium laser prostate enucleation

Primary outcome measure

  • Hemostasis time [ Time Frame: During surgery ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic Main

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

More Information

Sponsor

Smita De

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • BPH
  • Enlarged prostate
  • Thulio laser
  • Prostate enucleation
  • male urinary retention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Smita De on 2025-09-22.