RecruitingNCT07417449

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)


Sponsor

Ankara City Hospital Bilkent

Enrollment

1,000 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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.

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Interventions

DRUGDutasteride

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.

PROCEDUREHolmium Laser Enucleation of the Prostate (HoLEP)

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


Locations(1)

Ankara Bilkent City Hospital

Ankara, Universiteler, Turkey (Türkiye)

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NCT07417449