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)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostatic Hyperplasia, Benign
• Intervention / Treatment: Drug: Dutasteride; Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yusuf Gökkurt, MD, Specialist; Phone Number: +905067910557; Email: yusufgokkurt@gmail.com

Study Locations

• Turkey (Türkiye)
  • Universiteler
    • Ankara, Universiteler, Turkey (Türkiye), 06800
      • Recruiting
      • Ankara Bilkent City Hospital
      • Contact: Yusuf Gökkurt, MD; Phone Number: +90 506 791 0557; Email: yusufgokkurt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Male patients aged 40 to 80 years.
• Diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) and scheduled for elective Holmium Laser Enucleation of the Prostate (HoLEP).
• For the study group: Documented continuous use of Dutasteride (0.5 mg/day) for a minimum of 6 months immediately prior to the surgical date.
• For the control group: No history of 5-alpha reductase inhibitor (5-ARI) use within the last 12 months.
• Patients with complete medical records available in the Hospital Information Management System (HBYS).

Exclusion Criteria:

• Patients with a history of previous prostate surgery or pelvic radiotherapy.
• Patients diagnosed with prostate adenocarcinoma in the pathology results or those scheduled for a biopsy due to suspicion of prostate cancer prior to the operation.
• Cases with incomplete data in the hospital's electronic database, including missing operative notes, preoperative/postoperative hemoglobin levels, or resected tissue weight.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dutasteride Group; Patients who were treated with 0.5 mg/day dutasteride for at least 6 months prior to the HoLEP surgery.	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.
Control Group; Patients who underwent HoLEP surgery but had no history of using 5-alpha reductase inhibitors (5-ARIs) before the procedure.	Procedure: Holmium Laser Enucleation of the Prostate (HoLEP); Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	During the surgical procedure (intraoperative).
Enucleation Efficiency	The weight of the resected tissue divided by the enucleation time.	During the surgical procedure (intraoperative).

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dutasteride; Prostate Surgery; HoLEP; Perioperative Bleeding; 5-alpha Reductase Inhibitors
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Azasteroids; Steroids, Heterocyclic; Dutasteride
• Other Study ID Numbers: TABED 2-26-2108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No