Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation (TRI-LASER)

January 14, 2026 updated by: erol maraş, Ankara University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmet Furkan Ozsoy, Resident
  • Phone Number: +90 531 635 29 25

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Ankara University
        • Contact:
        • Sub-Investigator:
          • MEHMET EROL maras, resident
        • Sub-Investigator:
          • ahmet furkan ozsoy, resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Holmium:YAG Laser Enucleation
Participants in this arm will undergo anatomical prostate enucleation using Holmium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia.
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.
Active Comparator: Thulium:YAG Laser Enucleation
Participants in this arm will undergo anatomical prostate enucleation using Thulium:YAG laser 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.
Active Comparator: Thulium Fiber Laser (TFL) Enucleation
Participants in this arm will undergo anatomical prostate enucleation using Thulium Fiber Laser (TFL) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laser Enucleation Efficiency (g/J)
Time Frame: 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.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Prostate Symptom Score (IPSS)
Time Frame: Baseline (preoperative) and 3 months postoperatively
Change in the International Prostate Symptom Score (IPSS) from preoperative assessment to postoperative follow-up will be evaluated to assess functional outcomes after prostate enucleation.
Baseline (preoperative) and 3 months postoperatively
Postoperative Urinary Incontinence
Time Frame: Up to 3 months postoperatively
The presence of postoperative urinary incontinence will be assessed during routine postoperative follow-up visits.
Up to 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Mehmet Ilker Gokce, Prof., Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTF-TRI-LASER-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that underlie the results reported in publications will be made available upon reasonable request.

IPD Sharing Time Frame

Beginning 6 months after publication and ending 5 years after publication.

IPD Sharing Access Criteria

Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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