NCT07417449

Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP

The Impact of Long-Term Dutasteride Use on Surgical Outcomes and Perioperative Parameters in Patients Undergoing Holmium Laser Enucleation of the Prostate (HoLEP)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatic Hyperplasia, Benign

Interventions

Type	Name	Description
DRUG	Dutasteride	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.
PROCEDURE	Holmium Laser Enucleation of the Prostate (HoLEP)	Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2027-04-01
• First posted: 2026-02-18
• Last updated: 2026-04-06

Locations

1 site across 1 country: Turkey (Türkiye)