Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation

NCT07350005 · tracked via the Priya Life Science Turkey tracker

Sponsor

Ankara University

Phase

Not applicable

Started

2026-05

Last updated

2026-01-20

Condition(s) studied

BPH (Benign Prostatic Hyperplasia)

Investigational drug(s) / intervention(s)

Holmium:YAG Laser Prostate EnucleationThulium:YAG Laser Prostate EnucleationThulium Fiber Laser Prostate Enucleation

Holmium:YAG Laser Prostate Enucleation: Anatomical prostate enucleation performed using a Holmium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.

Thulium:YAG Laser Prostate Enucleation: Anatomical prostate enucleation performed using a Thulium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.

Thulium Fiber Laser Prostate Enucleation: Anatomical prostate enucleation performed using a Thulium Fiber Laser (TFL) system as part of standard surgical treatment for benign prostatic hyperplasia.

Study summary

Benign prostatic hyperplasia (BPH) is a common condition in aging men and may require surgical treatment when medical therapy is ineffective. Anatomical prostate enucleation using different laser technologies is a well-established surgical approach for the treatment of BPH.

The purpose of this prospective randomized study is to compare the efficiency and safety of three commonly used laser systems-Holmium:YAG, Thulium:YAG, and Thulium Fiber Laser (TFL)-during anatomical prostate enucleation.

The primary objective of the study is to evaluate laser efficiency by measuring grams of enucleated prostate tissue per joule (g/J) using intraoperative laser device data. Secondary outcomes include changes in International Prostate Symptom Score (IPSS) and the occurrence of postoperative urinary incontinence.

All laser systems used in this study are part of routine clinical practice, and no additional diagnostic procedures or treatments will be performed for study purposes

Eligibility

Sex

MALE

Min age

50 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Patients diagnosed with benign prostatic hyperplasia (BPH) and scheduled for anatomical prostate enucleation * Presence of a prostate and clinical indication for surgical treatment * Age between 50 and 80 years Exclusion Criteria: * History or suspicion of prostate cancer * Previous prostate surgery * Presence of neurogenic bladder or significant lower urinary tract dysfunction unrelated to BPH * Active urinary tract infection at the time of surgery * Severe comorbid conditions contraindicating surgery or anesthesia

Primary outcome measure(s)

Laser Enucleation Efficiency (g/J) — Intraoperative
Laser enucleation efficiency will be evaluated by calculating the amount of enucleated prostate tissue in grams per joule of laser energy used (g/J), based on intraoperative laser system data and enucleated tissue weight recorded during surgery.

Trial sites (1)

Facility	City	Region	Status
Ankara University	Ankara	Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07350005 on ClinicalTrials.gov ↗ ← All trials in Turkey