Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to investigate the effects of long-term dutasteride use (a 5-alpha reductase inhibitor) on surgical outcomes in patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) for benign prostatic hyperplasia (BPH).
While some studies suggest that short-term use of these medications can reduce bleeding during surgery, there is limited data on the impact of chronic, long-term use (at least 6 months) specifically during the HoLEP procedure.
The researchers will retrospectively analyze patient records to compare two groups: those who used dutasteride for 6 months or longer before surgery, and those who did not use any 5-alpha reductase inhibitors. The primary focus is to determine whether long-term dutasteride treatment leads to a significant difference in surgical bleeding (measured by hemoglobin drop), operation time, and the efficiency of removing prostate tissue (morcellation). The findings will help surgeons better understand how preoperative medication history influences the technical aspects of HoLEP surgery.
This is a retrospective, single-center, analytical cohort study conducted at the Ankara Bilkent City Hospital, Department of Urology. The study focuses on evaluating the perioperative and postoperative outcomes of patients who underwent Holmium Laser Enucleation of the Prostate (HoLEP) for symptomatic Benign Prostatic Hyperplasia (BPH).
Data will be collected through the Hospital Information Management System (HBYS) and patient archive records for those operated on between January 2024 and 2026. The study population will be divided into two main cohorts:
Dutasteride Group: Patients who have been continuously using dutasteride (0.5 mg/day) for at least 6 months prior to the surgery.
Control Group: Patients with no history of 5-alpha reductase inhibitor (5-ARI) use.
All surgical procedures were performed by experienced urologists using a standardized HoLEP technique. The following parameters will be analyzed and compared between the two groups:
Primary Perioperative Outcomes: Enucleation time (minutes), morcellation time (minutes), total operative time, and morcellation efficiency (grams/minute).
Hematological Parameters: Preoperative and postoperative hemoglobin (Hb) levels (first 24 hours) to determine the mean hemoglobin drop.
Tissue Analysis: Resected prostate tissue weight (grams) and its correlation with operative duration.
Statistical analysis will be performed to assess whether chronic dutasteride use provides a surgical advantage or alters the tissue characteristics during laser enucleation. Patients with a history of prostate cancer, previous prostate surgery, or those on dutasteride for less than 6 months will be excluded to maintain the integrity of the long-term usage data.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dutasteride Group | Patients who were treated with 0.5 mg/day dutasteride for at least 6 months prior to the HoLEP surgery. |
| |
| Control Group | Patients who underwent HoLEP surgery but had no history of using 5-alpha reductase inhibitors (5-ARIs) before the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride | Drug | Patients in the study group received 0.5 mg/day of dutasteride for at least 6 months before surgery as part of their routine BPH treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Levels (Hemoglobin Drop) | The difference between preoperative hemoglobin levels and postoperative (first 24 hours) hemoglobin levels to assess surgical bleeding. | From the time of hospital admission (preoperative) up to 24 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Morcellation Efficiency Rate | The weight of the resected prostate tissue divided by the morcellation time. | During the surgical procedure (intraoperative). |
| Total Operative Duration | Total time from the start of the enucleation to the completion of morcellation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study population consists of male patients diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) who underwent Holmium Laser Enucleation of the Prostate (HoLEP) at the Ankara Bilkent City Hospital, Urology Clinic. The study includes patients operated on between January 2024 and March 2026. Data will be retrieved from the hospital's electronic health records (HBYS) and patient archives, focusing on those with documented long-term dutasteride use (6 months or more) and those with no history of 5-alpha reductase inhibitor use as a comparison group.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusuf Gökkurt, MD, Specialist | Contact | +905067910557 | yusufgokkurt@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Recruiting | Ankara | Universiteler | 06800 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31801152 | Result | Shigemura K, Kitagawa K, Chen KC, Sung SY, Fujisawa M. Effect of Preoperative Dutasteride on Holmium Laser Enucleation of the Prostate. Urol Int. 2020;104(5-6):356-360. doi: 10.1159/000504265. Epub 2019 Dec 4. | |
| 29161905 | Result | Dimopoulos P, Christopoulos P, Kampantais S. A Focused Review on the Effects of Preoperative 5alpha-Reductase Inhibitors Treatment in Patients Undergoing Holmium Laser Enucleation of the Prostate: What Do We Know So Far? J Endourol. 2018 Feb;32(2):79-83. doi: 10.1089/end.2017.0734. Epub 2018 Jan 3. |
Not provided
Not provided
Individual participant data will not be shared to ensure patient confidentiality and to comply with the institutional data protection policies of the hospital. The results of the study will be presented in the final thesis and may be submitted for publication in peer-reviewed journals, but raw data containing patient information will remain restricted
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| Holmium Laser Enucleation of the Prostate (HoLEP) | Procedure | Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia. |
|
| During the surgical procedure (intraoperative). |
| Enucleation Efficiency | The weight of the resected tissue divided by the enucleation time. | During the surgical procedure (intraoperative). |
| 32167484 | Result | Busetto GM, Del Giudice F, Maggi M, Antonini G, D'Agostino D, Romagnoli D, Del Rosso A, Giampaoli M, Corsi P, Palmer K, Ferro M, Lucarelli G, Terracciano D, De Cobelli O, Sciarra A, De Berardinis E, Porreca A. Surgical blood loss during holmium laser enucleation of the prostate (HoLEP) is not affected by short-term pretreatment with dutasteride: a double-blind placebo-controlled trial on prostate vascularity. Aging (Albany NY). 2020 Mar 11;12(5):4337-4347. doi: 10.18632/aging.102883. Epub 2020 Mar 11. |
| D052801 |
| Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |