Does long-term dutasteride change HoLEP surgery outcomes?
Official title: The Impact of Long-Term Dutasteride Use on Surgical Outcomes and Perioperative Parameters in Patients Undergoing Holmium Laser Enucleation of the Prostate (HoLEP)
Run by Ankara City Hospital Bilkent · NCT07417449 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | Men only |
| Enrollment | 1000 (estimated) |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara, Universiteler) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | November 30, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07417449 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Ankara Bilkent City Hospital
Ankara, Universiteler, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Yusuf Gökkurt, MD, Specialist
- Email: yusufgokkurt@gmail.com
- Phone: +905067910557
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.