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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (preoperative) and 3 months postoperatively |
| Postoperative Urinary Incontinence |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Erol Maras, Resident | Contact | +90 552 666 6220 | mehmeterolmaras@gmail.com | |
| Ahmet Furkan Ozsoy, Resident | Contact | +90 531 635 29 25 |
| Name | Affiliation | Role |
|---|---|---|
| Mehmet Ilker Gokce, Prof. | Ankara University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University | Ankara | 06230 | Turkey (Türkiye) |
De-identified individual participant data that underlie the results reported in publications will be made available upon reasonable request.
Beginning 6 months after publication and ending 5 years after publication.
Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding investigator.
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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.
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| 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 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. |
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The presence of postoperative urinary incontinence will be assessed during routine postoperative follow-up visits. |
| Up to 3 months postoperatively |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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