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

NCT07417449 | Not Yet Recruiting

• 1 other identifier: DU-HOLEP-2026-Bilkent
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostatic Hyperplasia, Benign

Keywords

HoLEP; Dutasteride; 5-alpha Reductase Inhibitors; Prostate Surgery; Perioperative Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Morcellation Efficiency Rate

  During the surgical procedure (intraoperative).

• Total Operative Duration

  During the surgical procedure (intraoperative).

• Enucleation Efficiency

  During the surgical procedure (intraoperative).

Study Arms (2)

Dutasteride Group

Patients who were treated with 0.5 mg/day dutasteride for at least 6 months prior to the HoLEP surgery.

Drug: Dutasteride; Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

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)

Interventions

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.

Dutasteride Group

Holmium Laser Enucleation of the Prostate (HoLEP) PROCEDURE

Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia.

Control Group; Dutasteride Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Related Publications (3)

• 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.

  PMID: 31801152 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.

  PMID: 29161905 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.

  PMID: 32167484 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Yusuf Gökkurt, MD, Specialist

CONTACT

+905067910557; yusufgokkurt@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Specialist

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share