Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 12:23 AM
Study NCT ID:
NCT07350005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation
Sponsor:
Ankara University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRI-LASER
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: