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NCT Number: NCT07350005

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

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Key information

Conditions

BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, 06230, Turkey (Türkiye)

Location contact

MEHMET EROL maras, resident

SUB_INVESTIGATOR

Mehmet Ilker Gokce, Prof.

CONTACT

[email protected]

+90 312 508 35 67

ahmet furkan ozsoy, resident

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holmium:YAG Laser Prostate Enucleation

Procedure

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

Procedure

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

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Furkan Ozsoy, Resident

CONTACT

+90 531 635 29 25

Mehmet Erol Maras, Resident

CONTACT

[email protected]

+90 552 666 6220

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Acronym: TRI-LASER

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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