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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07417449
Enrollment
1000
Registered
2026-02-18
Start date
2026-04-01
Completion date
2027-04-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia, Benign

Keywords

HoLEP, Dutasteride, 5-alpha Reductase Inhibitors, Prostate Surgery, Perioperative Bleeding

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: Primary Perioperative Outcomes: Enucleation time (minutes), morcellation time (minutes), total operative time, and morcellation efficiency (grams/minute). Hematological Parameters: Preoperative and postoperative hemoglobin (Hb) levels (first 24 hours) to determine the mean hemoglobin drop. Tissue Analysis: Resected prostate tissue weight (grams) and its correlation with operative duration. Statistical analysis will be performed to assess whether chronic dutasteride use provides a surgical advantage or alters the tissue characteristics during laser enucleation. Patients with a history of prostate cancer, previous prostate surgery, or those on dutasteride for less than 6 months will be excluded to maintain the integrity of the long-term usage data.

Interventions

DRUGDutasteride

Patients in the study group received 0.5 mg/day of dutasteride for at least 6 months before surgery as part of their routine BPH treatment.

Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Hemoglobin Levels (Hemoglobin Drop)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

MeasureTime frameDescription
Morcellation Efficiency RateDuring the surgical procedure (intraoperative).The weight of the resected prostate tissue divided by the morcellation time.
Total Operative DurationDuring the surgical procedure (intraoperative).Total time from the start of the enucleation to the completion of morcellation.
Enucleation EfficiencyDuring the surgical procedure (intraoperative).The weight of the resected tissue divided by the enucleation time.

Countries

Turkey (Türkiye)

Contacts

CONTACTYusuf Gökkurt, MD, Specialist
yusufgokkurt@gmail.com+905067910557

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026