BPH (Benign Prostatic Hyperplasia)TRI-LASERNCT07350005
Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation
A study testing Holmium:YAG Laser Prostate Enucleation, Thulium:YAG Laser Prostate Enucleation and Thulium Fiber Laser Prostate Enucleation in people with BPH (Benign Prostatic Hyperplasia), run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- Holmium:YAG Laser Prostate Enucleation, Thulium:YAG Laser Prostate Enucleation and Thulium Fiber Laser Prostate Enucleation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmet Furkan Ozsoy, Resident contact
Turkey (Türkiye)1 site
Ankara University
Ankara, 06230
Mehmet Ilker Gokce, Prof., +90 312 508 35 67, migokce@ankara.edu.tr
MEHMET EROL maras, resident
About this study
Official title: A Prospective Randomized Study Comparing the Efficiency and Safety of Holmium:YAG, Thulium:YAG, and Thulium Fiber Lasers in Anatomical Prostate Enucleation
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.
Read more
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
Read the 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.
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- Holmium:YAG Laser Prostate Enucleation, Thulium:YAG Laser Prostate Enucleation, Thulium Fiber Laser Prostate Enucleation
- Keywords
- bph, prostate, holmium, thulium, TFL
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium:YAG Laser Prostate EnucleationProcedure or surgery
Anatomical prostate enucleation performed using a Holmium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.
Thulium:YAG Laser Prostate EnucleationProcedure or surgery
Anatomical prostate enucleation performed using a Thulium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.
Thulium Fiber Laser Prostate EnucleationProcedure or surgery
Anatomical prostate enucleation performed using a Thulium Fiber Laser (TFL) system as part of standard surgical treatment for benign prostatic hyperplasia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Thulium Fiber Laser Prostate Enucleation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative
Secondary outcomes (2)
Change in International Prostate Symptom Score (IPSS)
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.
Measured: Baseline (preoperative) and 3 months postoperatively
Postoperative Urinary Incontinence
The presence of postoperative urinary incontinence will be assessed during routine postoperative follow-up visits.
Measured: Up to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, erol maraş, Ankara University
- Investigators
- Mehmet Ilker Gokce, Prof., Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350005
- Sponsor's protocol ID
- AUTF-TRI-LASER-01
- Acronym
- TRI-LASER
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing the Efficiency and Safety of Holmium:YAG, Thulium:YAG, and Thulium Fiber Lasers in Anatomical Prostate Enucleation
- ClinicalTrials.gov ID
- NCT07350005
- Acronym / sponsor ID
- TRI-LASER / AUTF-TRI-LASER-01
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Keywords
- bph, prostate, holmium, thulium, TFL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Holmium:YAG Laser Enucleation | Active comparator | Procedure: Holmium:YAG Laser Prostate EnucleationParticipants in this arm will undergo anatomical prostate enucleation using Holmium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia. |
| Thulium:YAG Laser Enucleation | Active comparator | Procedure: Thulium:YAG Laser Prostate EnucleationParticipants in this arm will undergo anatomical prostate enucleation using Thulium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia. |
| Thulium Fiber Laser (TFL) Enucleation | Active comparator | Procedure: Thulium Fiber Laser Prostate EnucleationParticipants in this arm will undergo anatomical prostate enucleation using Thulium Fiber Laser (TFL) as part of standard surgical treatment for benign prostatic hyperplasia. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium:YAG Laser Prostate EnucleationAnatomical prostate enucleation performed using a Holmium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia. | Procedure or surgery | Holmium:YAG Laser Enucleation |
| Thulium:YAG Laser Prostate EnucleationAnatomical prostate enucleation performed using a Thulium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia. | Procedure or surgery | Thulium:YAG Laser Enucleation |
| Thulium Fiber Laser Prostate EnucleationAnatomical prostate enucleation performed using a Thulium Fiber Laser (TFL) system as part of standard surgical treatment for benign prostatic hyperplasia. | Procedure or surgery | Thulium Fiber Laser (TFL) Enucleation |
Primary outcome
Laser Enucleation Efficiency (g/J)
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmet Furkan Ozsoy, Resident contact
Mehmet Ilker Gokce, Prof. principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium:YAG Laser Prostate Enucleation, Thulium:YAG Laser Prostate Enucleation and Thulium Fiber Laser Prostate Enucleation in people with BPH (Benign Prostatic Hyperplasia), run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Erol Maras, Resident (+90 552 666 6220, mehmeterolmaras@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser Enucleation Efficiency (g/J) (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.