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NCT Number: NCT07417449

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Universiteler, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yusuf Gökkurt, MD

CONTACT

[email protected]

+90 506 791 0557

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dutasteride

Drug

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.

Holmium Laser Enucleation of the Prostate (HoLEP)

Procedure

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

Primary outcomes

  1. 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

  1. Morcellation Efficiency Rate

    Time frame: During the surgical procedure (intraoperative).

    The weight of the resected prostate tissue divided by the morcellation time.

  2. Total Operative Duration

    Time frame: During the surgical procedure (intraoperative).

    Total time from the start of the enucleation to the completion of morcellation.

  3. Enucleation Efficiency

    Time frame: During the surgical procedure (intraoperative).

    The weight of the resected tissue divided by the enucleation time.

Study contacts

Contact information is provided by the study sponsor or research team.

Yusuf Gökkurt, MD, Specialist

CONTACT

[email protected]

+905067910557

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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