NCT07350005

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

A Prospective Randomized Study Comparing the Efficiency and Safety of Holmium:YAG, Thulium:YAG, and Thulium Fiber Lasers in Anatomical Prostate Enucleation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Ankara University · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, randomized, single-center clinical study designed to compare the efficiency and safety of three different laser systems used in anatomical prostate enucleation for the surgical treatment of benign prostatic hyperplasia (BPH). Eligible patients will be randomly assigned to undergo prostate enucleation using one of the following laser technologies: Holmium:YAG laser, Thulium:YAG laser, or Thulium Fiber Laser (TFL). All procedures will be performed according to standard surgical techniques routinely used in clinical practice. The primary outcome of the study is laser efficiency, which will be evaluated using intraoperative laser system data,including grams of enucleated prostate tissue per joule (g/J). Preoperative prostate volume and intraoperative laser parameters are routinely recorded and will be used for analysis. No additional diagnostic procedures or treatments will be performed specifically for study purposes. Secondary outcomes include changes in the International Prostate Symptom Score (IPSS) from preoperative assessment to postoperative follow-up and the presence of postoperative urinary incontinence. Safety assessment will be based on perioperative and postoperative adverse events recorded during routine clinical care. The study will be conducted in accordance with ethical principles and applicable regulatory requirements, and patient confidentiality will be maintained throughout the study period.

Conditions

• BPH (Benign Prostatic Hyperplasia)

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-11-01
• Completion: 2028-01-01
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: Turkey (Türkiye)