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

Ankara University

Status: Begins enrollment in 2 months

Conditions: BPH (Benign Prostatic Hyperplasia)

Treatments: Procedure: Thulium Fiber Laser Prostate Enucleation; Procedure: Holmium:YAG Laser Prostate Enucleation; Procedure: Thulium:YAG Laser Prostate Enucleation

Study type: Interventional

Funder types: Other

Identifiers

NCT07350005

AUTF-TRI-LASER-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 159 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 3 patient groups

Holmium:YAG Laser Enucleation

Active Comparator group

Description:

Participants in this arm will undergo anatomical prostate enucleation using Holmium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia.

Treatment:

Procedure: Holmium:YAG Laser Prostate Enucleation

Thulium:YAG Laser Enucleation

Active Comparator group

Description:

Participants in this arm will undergo anatomical prostate enucleation using Thulium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia.

Treatment:

Procedure: Thulium:YAG Laser Prostate Enucleation

Thulium Fiber Laser (TFL) Enucleation

Active Comparator group

Description:

Participants in this arm will undergo anatomical prostate enucleation using Thulium Fiber Laser (TFL) as part of standard surgical treatment for benign prostatic hyperplasia.

Treatment:

Procedure: Thulium Fiber Laser Prostate Enucleation