Menu
Recruiting NCT07417449

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

— Observational Prostatic Hyperplasia, Benign

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dutasteride, Holmium Laser Enucleation of the Prostate (HoLEP).
Who it may be relevant to
Registry conditions: Prostatic Hyperplasia, Benign. Basic parameters: 40 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

  • Drug Dutasteride
    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.
  • Procedure Holmium Laser Enucleation of the Prostate (HoLEP)
    Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia.

Primary outcome measures

  • Change in Hemoglobin Levels (Hemoglobin Drop) [Time frame: From the time of hospital admission (preoperative) up to 24 hours after surgery.]
Secondary outcome measures (3)
  • Morcellation Efficiency Rate [Time frame: During the surgical procedure (intraoperative).]
  • Total Operative Duration [Time frame: During the surgical procedure (intraoperative).]
  • Enucleation Efficiency [Time frame: During the surgical procedure (intraoperative).]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital — Ankara

Publications

  • Shigemura K, Kitagawa K, Chen KC, Sung SY, Fujisawa M. Effect of Preoperative Dutasteride on Holmium Laser Enucleation of the Prostate. Urol Int. 2020;104(5-6):356-360. doi: 10.1159/000504265. Epub 2019 Dec 4. PMID 31801152
  • Dimopoulos P, Christopoulos P, Kampantais S. A Focused Review on the Effects of Preoperative 5alpha-Reductase Inhibitors Treatment in Patients Undergoing Holmium Laser Enucleation of the Prostate: What Do We Know So Far? J Endourol. 2018 Feb;32(2):79-83. doi: 10.1089/end.2017.0734. Epub 2018 Jan 3. PMID 29161905
  • Busetto GM, Del Giudice F, Maggi M, Antonini G, D'Agostino D, Romagnoli D, Del Rosso A, Giampaoli M, Corsi P, Palmer K, Ferro M, Lucarelli G, Terracciano D, De Cobelli O, Sciarra A, De Berardinis E, Porreca A. Surgical blood loss during holmium laser enucleation of the prostate (HoLEP) is not affected by short-term pretreatment with dutasteride: a double-blind placebo-controlled trial on prostate PMID 32167484

Identifiers

NCT: NCT07417449 · TABED 2-26-2108

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗