Health TrialsbyHealthPanel

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

ConditionProstatic Hyperplasia, Benign
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40-80
SponsorAnkara City Hospital Bilkent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population consists of male patients diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) who underwent Holmium Laser Enucleation of the Prostate (HoLEP) at the Ankara Bilkent City Hospital, Urology Clinic. The study includes patients operated on between January 2024 and March 2026. Data will be retrieved from the hospital's electronic health records (HBYS) and patient archives, focusing on those with documented long-term dutasteride use (6 months or more) and those with no history of 5-alpha reductase inhibitor use as a comparison group.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Dutasteride Group2 interventions
Group B: Control Group1 intervention

Trial outcomes

Primary outcomes

1

Change in Hemoglobin Levels (Hemoglobin Drop)

The difference between preoperative hemoglobin levels and postoperative (first 24 hours) hemoglobin levels to assess surgical bleeding.

Time frame
From the time of hospital admission (preoperative) up to 24 hours after surgery.

Secondary outcomes

1

Morcellation Efficiency Rate

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

Time frame
During the surgical procedure (intraoperative).
2

Total Operative Duration

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

Time frame
During the surgical procedure (intraoperative).
3

Enucleation Efficiency

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

Time frame
During the surgical procedure (intraoperative).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara City Hospital Bilkent

Lead sponsor

Source ClinicalTrials.gov
Apply now