Does long-term dutasteride change HoLEP surgery outcomes?

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

We will try to see if men with BPH who took dutasteride for six months or longer have less bleeding, different operation times, or changes in tissue removal efficiency during HoLEP compared with men who did not take 5-alpha reductase inhibitors.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: Ankara City Hospital Bilkent (Academic / other)
• Locations: 1 site (Ankara, Universiteler)
• Trial ID: NCT07417449 on ClinicalTrials.gov

What this trial studies

This is a retrospective single-center cohort analysis of patients who underwent Holmium Laser Enucleation of the Prostate (HoLEP) at Ankara Bilkent City Hospital between 2024 and 2026. Patients will be grouped into those with continuous dutasteride use for at least six months prior to surgery and those with no 5-ARI use, and clinical records will be extracted from the hospital information system. Primary outcomes include hemoglobin drop in the first 24 hours, enucleation and morcellation times, total operative time, morcellation efficiency, and resected tissue weight. Statistical comparisons will determine whether chronic dutasteride exposure is associated with differences in perioperative bleeding or surgical efficiency.

Who should consider this trial

Good fit: Ideal candidates are men aged 40–80 with symptomatic benign prostatic hyperplasia who underwent elective HoLEP and either used dutasteride 0.5 mg/day continuously for ≥6 months or had no 5-ARI use within the prior 12 months, with complete hospital records available.

Not a fit: Patients with prior prostate surgery, pelvic radiotherapy, diagnosed prostate cancer, or incomplete/missing operative or hemoglobin data are unlikely to benefit from inclusion or from the specific findings of this analysis.

Why it matters

Potential benefit: If positive, the results could help surgeons predict bleeding risk and optimize preoperative medication timing to make HoLEP safer and more efficient.

How similar studies have performed: Previous short-term use of 5-ARIs has been reported to reduce perioperative bleeding in some prostate surgeries, but long-term (≥6 months) effects specifically during HoLEP are not well established.

Eligibility criteria

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.

Where this trial is running

Ankara, Universiteler

• Ankara Bilkent City Hospital — Ankara, Universiteler, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Yusuf Gökkurt, MD, Specialist

Conditions Prostatic Hyperplasia, Benign; HoLEP; Dutasteride; 5-alpha Reductase Inhibitors; Prostate Surgery; Perioperative Bleeding