Prostatic Hyperplasia, BenignNCT07417449
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
An observational study of Prostatic Hyperplasia, Benign, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign
- What is being tested?
- Dutasteride and Holmium Laser Enucleation of the Prostate (HoLEP)
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Universiteler, 06800
Yusuf Gökkurt, MD, +90 506 791 0557, yusufgokkurt@gmail.com
About this study
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)
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.
Read the 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.
- Conditions
- Prostatic Hyperplasia, Benign
- Being tested
- Dutasteride, Holmium Laser Enucleation of the Prostate (HoLEP)
- Keywords
- HoLEP, Dutasteride, 5-alpha Reductase Inhibitors, Prostate Surgery, Perioperative Bleeding
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
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 or surgery
Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia.
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride Group | Patients who were treated with 0.5 mg/day dutasteride for at least 6 months prior to the HoLEP surgery. Receives: Drug: Dutasteride; Procedure: Holmium Laser Enucleation of the Prostate (HoLEP) | |
| Control Group | Patients who underwent HoLEP surgery but had no history of using 5-alpha reductase inhibitors (5-ARIs) before the procedure. Receives: Procedure: Holmium Laser Enucleation of the Prostate (HoLEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Levels (Hemoglobin Drop)
The difference between preoperative hemoglobin levels and postoperative (first 24 hours) hemoglobin levels to assess surgical bleeding.
Measured: From the time of hospital admission (preoperative) up to 24 hours after surgery.
Secondary outcomes (3)
Morcellation Efficiency Rate
The weight of the resected prostate tissue divided by the morcellation time.
Measured: During the surgical procedure (intraoperative).
Total Operative Duration
Total time from the start of the enucleation to the completion of morcellation.
Measured: During the surgical procedure (intraoperative).
Enucleation Efficiency
The weight of the resected tissue divided by the enucleation time.
Measured: During the surgical procedure (intraoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostatic Hyperplasia, BenignStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Gökkurt, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417449
- Sponsor's protocol ID
- TABED 2-26-2108
- Status last verified
- Nov 2026
- First submitted
- 11 Feb 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to ensure patient confidentiality and to comply with the institutional data protection policies of the hospital. The results of the study will be presented in the final thesis and may be submitted for publication in peer-reviewed journals, but raw data containing patient information will remain restricted
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.
PubMed 31801152Dimopoulos 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.
PubMed 29161905Busetto 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 vascularity. Aging (Albany NY). 2020 Mar 11;12(5):4337-4347. doi: 10.18632/aging.102883. Epub 2020 Mar 11.
PubMed 32167484
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07417449
- Acronym / sponsor ID
- TABED 2-26-2108
- Conditions
- Prostatic Hyperplasia, Benign
- Keywords
- HoLEP, Dutasteride, 5-alpha Reductase Inhibitors, Prostate Surgery, Perioperative Bleeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dutasteride Group | – | Drug: Dutasteride, Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)Patients who were treated with 0.5 mg/day dutasteride for at least 6 months prior to the HoLEP surgery. |
| Control Group | – | Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)Patients who underwent HoLEP surgery but had no history of using 5-alpha reductase inhibitors (5-ARIs) before the procedure. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DutasteridePatients 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. | Drug | Dutasteride Group |
| Holmium Laser Enucleation of the Prostate (HoLEP)Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia. | Procedure or surgery | Control Group, Dutasteride Group |
Primary outcome
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.
3 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 31801152Shigemura 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.
- Results publication: PubMed 29161905Dimopoulos 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.
- Results publication: PubMed 32167484Busetto 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 vascularity. Aging (Albany NY). 2020 Mar 11;12(5):4337-4347. doi: 10.18632/aging.102883. Epub 2020 Mar 11.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to ensure patient confidentiality and to comply with the institutional data protection policies of the hospital. The results of the study will be presented in the final thesis and may be submitted for publication in peer-reviewed journals, but raw data containing patient information will remain restricted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, Benign, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusuf Gökkurt, MD, Specialist (+905067910557, yusufgokkurt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin Levels (Hemoglobin Drop) (time frame: From the time of hospital admission (preoperative) up to 24 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07417449, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.