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

Recruitingn/aAges 40 Years - 80 YearsMaleAnkara City Hospital Bilkent
NCT07417449 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Dutasteride
  • Holmium Laser Enucleation of the Prostate (HoLEP)
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Where

1 site
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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