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Not yet recruiting NCT07350005

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

No phase Interventional BPH (Benign Prostatic Hyperplasia)

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Holmium:YAG Laser Prostate Enucleation, Thulium:YAG Laser Prostate Enucleation, Thulium Fiber Laser Prostate Enucleation.
Who it may be relevant to
Registry conditions: BPH (Benign Prostatic Hyperplasia). Basic parameters: 50 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Laser Enucleation Efficiency (g/J) [Time frame: Intraoperative]
Secondary outcome measures (2)
  • Change in International Prostate Symptom Score (IPSS) [Time frame: Baseline (preoperative) and 3 months postoperatively]
  • Postoperative Urinary Incontinence [Time frame: Up to 3 months postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara University — Ankara

Identifiers

NCT: NCT07350005 · AUTF-TRI-LASER-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗