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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07350005

Acronym

TRI-LASER

Enrollment

159

Registered

2026-01-20

Start date

2026-05-01

Completion date

2028-01-01

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

bph, prostate, holmium, thulium, TFL

Brief 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.

Interventions

PROCEDUREHolmium:YAG Laser Prostate Enucleation

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

PROCEDUREThulium:YAG Laser Prostate Enucleation

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

PROCEDUREThulium 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Participants will be randomly assigned in parallel to one of three intervention arms corresponding to Holmium:YAG, Thulium:YAG, or Thulium Fiber Laser-based anatomical prostate enucleation.

Eligibility

Sex/Gender

MALE

Age

50 Years to 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Change in International Prostate Symptom Score (IPSS)	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.
Postoperative Urinary Incontinence	Up to 3 months postoperatively	The presence of postoperative urinary incontinence will be assessed during routine postoperative follow-up visits.

Countries

Turkey (Türkiye)

Contacts

CONTACTMehmet Erol Maras, Resident

mehmeterolmaras@gmail.com+90 552 666 6220

CONTACTAhmet Furkan Ozsoy, Resident

+90 531 635 29 25

PRINCIPAL_INVESTIGATORMehmet Ilker Gokce, Prof.

Ankara University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026