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

NCT07350005 | Not Yet Recruiting

• 1 other identifier: AUTF-TRI-LASER-01
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

bph; prostate; holmium; thulium; TFL

Outcome Measures

Primary Outcomes (1)

• Laser Enucleation Efficiency (g/J)

  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.

  Intraoperative

Secondary Outcomes (2)

• Change in International Prostate Symptom Score (IPSS)

  Baseline (preoperative) and 3 months postoperatively

• Postoperative Urinary Incontinence

  Up to 3 months postoperatively

Study Arms (3)

Holmium:YAG Laser Enucleation

ACTIVE COMPARATOR

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

Procedure: Holmium:YAG Laser Prostate Enucleation

Thulium:YAG Laser Enucleation

ACTIVE COMPARATOR

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

Procedure: Thulium:YAG Laser Prostate Enucleation

Thulium Fiber Laser (TFL) Enucleation

ACTIVE COMPARATOR

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

Procedure: Thulium Fiber Laser Prostate Enucleation

Interventions

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.

Holmium:YAG Laser Enucleation

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:YAG Laser Enucleation

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.

Thulium Fiber Laser (TFL) Enucleation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Individuals of any gender identity who have a prostate and meet the clinical eligibility criteria for prostate enucleation surgery are eligible to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mehmet Ilker Gokce, Prof.

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Erol Maras, Resident

CONTACT

+90 552 666 6220; mehmeterolmaras@gmail.com

Ahmet Furkan Ozsoy, Resident

CONTACT

+90 531 635 29 25

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding investigator.

Locations

TU (1)