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

Recruiting now

Conditions studied: Prostatic Hyperplasia, Benign

In brief

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.

Key facts

Study ID: NCT07417449
Run by: Ankara City Hospital Bilkent
People needed: 1000
Starts: 2026-04-01
Expected to finish: 2027-04-01
Last updated by the study team: 2026-04-06

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

Ankara Bilkent City Hospital — Ankara, Universiteler, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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