The Impact of Long-Term Dutasteride Use on Surgical Outcomes and Perioperative Parameters in Patients Undergoing Holmium Laser Enucleation of the Prostate (HoLEP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Change in Hemoglobin Levels (Hemoglobin Drop)
Study Overview
Brief 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.
Detailed Description
This is a retrospective, single-center, analytical cohort study conducted at the Ankara Bilkent City Hospital, Department of Urology. The study focuses on evaluating the perioperative and postoperative outcomes of patients who underwent Holmium Laser Enucleation of the Prostate (HoLEP) for symptomatic Benign Prostatic Hyperplasia (BPH).
Data will be collected through the Hospital Information Management System (HBYS) and patient archive records for those operated on between January 2024 and 2026. The study population will be divided into two main cohorts:
Dutasteride Group: Patients who have been continuously using dutasteride (0.5 mg/day) for at least 6 months prior to the surgery.
Control Group: Patients with no history of 5-alpha reductase inhibitor (5-ARI) use.
All surgical procedures were performed by experienced urologists using a standardized HoLEP technique. The following parameters will be analyzed and compared between the two groups:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Dutasteride Group
Patients who were treated with 0.5 mg/day dutasteride for at least 6 months prior to the HoLEP surgery.
Intervention: Holmium Laser Enucleation of the Prostate (HoLEP) (Procedure)
Control Group
Patients who underwent HoLEP surgery but had no history of using 5-alpha reductase inhibitors (5-ARIs) before the procedure.
Intervention: Holmium Laser Enucleation of the Prostate (HoLEP) (Procedure)
Dutasteride Group
Patients who were treated with 0.5 mg/day dutasteride for at least 6 months prior to the HoLEP surgery.
Intervention: Dutasteride (Drug)
Outcomes
Primary Outcomes
Change in Hemoglobin Levels (Hemoglobin Drop)
Time Frame: From the time of hospital admission (preoperative) up to 24 hours after surgery.
The difference between preoperative hemoglobin levels and postoperative (first 24 hours) hemoglobin levels to assess surgical bleeding.
Secondary Outcomes
- Morcellation Efficiency Rate(During the surgical procedure (intraoperative).)
- Total Operative Duration(During the surgical procedure (intraoperative).)
- Enucleation Efficiency(During the surgical procedure (intraoperative).)
Investigators
Yusuf Gökkurt
Urology Specialist
Ankara City Hospital Bilkent