Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract SymptomsNCT07585552
Anesthesia Type and HoLEP Outcomes: A Multi-Center Study
An observational study of Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
1. What is this study about, and why is it required? The goal of this observational study is to learn if anesthesia type (e.g., general anesthesia, spinal anesthesia) affects the safety and efficiency of HoLEP surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms
- How many people
- 320 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2026to 1 Sep 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients undergoing HoLEP for BPO.
Who may be able to join
- 18 years or older men who have BPO requiring surgical treatment.
- Participants who can give written informed consent.
- Having no more than 3 points for the American Society of Anesthesiologists (ASA) physical status classification scale (ASA 1 to 3).
Who cannot join
- Absolute contraindication for spinal or general anesthesia
- History of previous surgery for prostate (e.g., surgery for prostate cancer, surgery for benign prostate obstruction)
- Uncorrected bleeding disorder (INR > 1.5)
- Participants who are not willing to give informed consent.
- Participants who have a proven urinary tract infection at the time of the surgery.
- Participants who are not able to be contacted for regular follow-ups.
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
Ondokuz Mayis University, Faculty of Medicine, Department of Urology
Samsun
Murat Gulsen, Assistant Professor, +905062357421, mglotr@gmail.com
About this study
Official title: Does Anesthesia Type Affect HoLEP Outcomes? A Multi-Center, Real-World Comparative Study
- What is this study about, and why is it required? The goal of this observational study is to learn if anesthesia type (e.g., general anesthesia, spinal anesthesia) affects the safety and efficiency of HoLEP surgery. The main question it aims to answer is:
- Is a particular type of anesthesia related to less or more bleeding during the surgery?
Read more
- What will be assessed to answer the main question of this study? (Outcome measure(s)) 2.1. Primary outcome measure of this study is:
- Change in the hemoglobin level perioperatively. 2.2. Secondary outcome measures are:
- Requirement for the usage of any vasoactive medication due to low blood pressure
- Time passed until discharge.
- Time passed until the removal of the bladder drainage catheter.
- Ratio of the unwanted events that require additional intervention other than medication, fluids, or blood transfusions (Complications, Clavien-Dindo Grade III or higher).
- International symptom questionnaire score 3 months after surgery.
- Quality of life (QoL) score 3 months after surgery.
- Peak urinary current velocity (Qmax) and post-void residual volume measurement 3 months after surgery.
- Can anyone participate in this study?
Voluntary participants should meet the following criteria:
- Being older than 18 years old.
- Having bothersome lower urinary tract symptoms due to prostatic enlargement requiring surgical treatment.
- Having no untreated or uncontrolled systemic disease, which refers to having an ASA (American Society of Anesthesiologists Physical Status Classification System) score III at most.
Read the detailed description
Benign prostatic obstruction (BPO) is the leading cause of lower urinary tract symptoms (LUTS) among men older than 40 years.
Surgery is recommended under circumstances such as:
- Bothersome LUTS resistant to medical treatment.
- Acute kidney injury, bladder stone(s), resistant hematuria and urinary retention.
- Preference of the patient.
Various surgical methods exist to treat BPO, but the most appropriate choice depends on the operator and the patient.
HoLEP is an abbreviation for holmium laser enucleation of prostate, which is one of the endoscopic laser enucleation techniques.
Both spinal and general anesthesia are applicable for HoLEP surgery. The type of anesthesia is determined by the anesthesiologist, independently of the operator's preference, taking into account several factors related to the patient, such as safety and comfort.
Controlled bleeding is one of the expected outcomes in HoLEP, and several factors determine the amount of bleeding. For HoLEP, the type of anesthesia may be one of them, as other studies have claimed. This multicenter, prospective observational study may further reveal the impact of anesthesia type on bleeding.
The amount of bleeding could be "less or more", determined according to the content below:
- Amount of hemoglobin and hematocrit decreased, measured by laboratory examinations, preoperatively, during, and on the day after the surgery.
- Vital changes such as hypotension, tachycardia, that require blood transfusion due to "more" bleeding during either the surgery or hospital stay after surgery.
- Usually, a shorter duration of bladder irrigation to clean blood in the urine during hospital stay after the surgery is required for "less" bleeding.
Participants who are eligible and willing to provide informed consent will undergo HoLEP. Preoperative, perioperative, and postoperative data will be collected without disclosing the participant or any personal data relating to the participant.
Participants will be grouped into two groups based on anesthesia type: general or spinal.
To answer the main question of this study, a power analysis was conducted, concluding that at least 320 participants are required (intention-to-treat population).
All collected data will be recorded and analyzed according to the proper statistical methods. Results will be reported.
- Keywords
- HoLEP, Benign Prostate Obstruciton (BPO), Male LUTS, Real World Study, Observational Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Participants undergoing HoLEP under general anesthesia (intubation or laryngeal mask airway) | |
| Spinal Anesthesia | Participants undergoing HoLEP under spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin change
Difference between preoperative and postoperative hemoglobin levels (g/dL)
Measured: First day after HoLEP is performed.
Secondary outcomes (8)
International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery
The severity of lower urinary tract symptoms and their impact on quality of life should be assessed using a validated questionnaire.
- 0 to 35 points for IPSS
- 0 to 6 points for QoL Scale variable.
Measured: At 3 months after HoLEP
Duration of hospitalization
Day(s) passed until discharge after HoLEP.
Measured: Postoperative second to seventh days after HoLEP.
Duration of catheterization
Day(s) passed until the removal of the bladder drainage catheter after HoLEP.
Measured: From the time of HoLEP until the removal of the catheter.
Ratio of high grade complications
Complications will be classified according to the Clavien-Dindo classification. Clavien-Dindo Grade III or higher is considered a high-grade complication.
Measured: From the time of HoLEP to 30 days after HoLEP.
Peak Urinary Flow (Qmax)
Peak urinary flow (mL/sec), at 3 months after HoLEP.
Measured: At 3 months after HoLEP.
Post-void residual (PVR)
Post-void residual (PVR) volume (mL) measurement at 3 months after HoLEP
Measured: At 3 months after HoLEP
Enucleation Efficiency
Weight of the enucleated adenoma per operative minute (grams/min).
Measured: From the start of HoLEP to the end of HoLEP (Operative time).
Ratio of intraoperative vasoactive medication requirement
Number of participants who required vasoactive medication during anesthesia for HoLEP due to low blood pressure, as a percentage of the total number of participants.
Measured: During the anesthesia for HoLEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start23 Apr 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 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 Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Gulsen, Ondokuz Mayıs University
- Investigators
- Murat Gulsen, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585552
- Sponsor's protocol ID
- MIUS.2026.002
- Status last verified
- Apr 2026
- First submitted
- 5 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations, including the Turkish Personal Data Protection Law (KVKK). Only aggregated, de-identified results will be reported in publications and presentations.
Publications
Haehn DA, Chadha RM, Porter SB, Pathak RA, Lyon TD, Hochwald AP, Dora CD. Same-day Discharge Following Holmium Laser Enucleation of the Prostate Under Spinal Anesthesia: A Propensity Score Matched Comparison With General Anesthesia. Urology. 2025 Feb;196:260-264. doi: 10.1016/j.urology.2024.11.058. Epub 2024 Nov 30.
PubMed 39622439Silvani C, Lucignani G, Bebi C, Turetti M, Ripa F, Zanetti SP, De Lorenzis E, Albo G, Longo F, Gadda F, Montanari E, Boeri L. General anesthesia is associated with lower perioperative bleeding and better functional outcomes than spinal anesthesia for endoscopic enucleation of the prostate: a single-center experience. World J Urol. 2024 Oct 9;42(1):569. doi: 10.1007/s00345-024-05271-z.
PubMed 39382595Westhofen T, Schott M, Keller P, Tamalunas A, Atzler M, Ebner B, Schultheiss M, Damm A, Kowalski C, Stief CG, Magistro G. Spinal Versus General Anesthesia for Holmium Laser Enucleation of the Prostate of High-risk Patients - A Propensity-score-matched-analysis. Urology. 2022 Jan;159:182-190. doi: 10.1016/j.urology.2021.04.078. Epub 2021 Jul 31.
PubMed 34339752
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Anesthesia Type Affect HoLEP Outcomes? A Multi-Center, Real-World Comparative Study
- ClinicalTrials.gov ID
- NCT07585552
- Acronym / sponsor ID
- MIUS.2026.002
- Keywords
- HoLEP, Benign Prostate Obstruciton (BPO), Male LUTS, Real World Study, Observational Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 23 Apr 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 13 May 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.
- What is this study about, and why is it required? The goal of this observational study is to learn if anesthesia type (e.g., general anesthesia, spinal anesthesia) affects the safety and efficiency of HoLEP surgery. The main question it aims to answer is:
- Is a particular type of anesthesia related to less or more bleeding during the surgery?
- What will be assessed to answer the main question of this study? (Outcome measure(s)) 2.1. Primary outcome measure of this study is:
- Change in the hemoglobin level perioperatively. 2.2. Secondary outcome measures are:
- Requirement for the usage of any vasoactive medication due to low blood pressure
- Time passed until discharge.
- Time passed until the removal of the bladder drainage catheter.
- Ratio of the unwanted events that require additional intervention other than medication, fluids, or blood transfusions (Complications, Clavien-Dindo Grade III or higher).
- International symptom questionnaire score 3 months after surgery.
- Quality of life (QoL) score 3 months after surgery.
- Peak urinary current velocity (Qmax) and post-void residual volume measurement 3 months after surgery.
- Can anyone participate in this study?
Voluntary participants should meet the following criteria:
- Being older than 18 years old.
- Having bothersome lower urinary tract symptoms due to prostatic enlargement requiring surgical treatment.
- Having no untreated or uncontrolled systemic disease, which refers to having an ASA (American Society of Anesthesiologists Physical Status Classification System) score III at most.
Detailed description
Benign prostatic obstruction (BPO) is the leading cause of lower urinary tract symptoms (LUTS) among men older than 40 years.
Surgery is recommended under circumstances such as:
- Bothersome LUTS resistant to medical treatment.
- Acute kidney injury, bladder stone(s), resistant hematuria and urinary retention.
- Preference of the patient.
Various surgical methods exist to treat BPO, but the most appropriate choice depends on the operator and the patient.
HoLEP is an abbreviation for holmium laser enucleation of prostate, which is one of the endoscopic laser enucleation techniques.
Both spinal and general anesthesia are applicable for HoLEP surgery. The type of anesthesia is determined by the anesthesiologist, independently of the operator's preference, taking into account several factors related to the patient, such as safety and comfort.
Controlled bleeding is one of the expected outcomes in HoLEP, and several factors determine the amount of bleeding. For HoLEP, the type of anesthesia may be one of them, as other studies have claimed. This multicenter, prospective observational study may further reveal the impact of anesthesia type on bleeding.
The amount of bleeding could be "less or more", determined according to the content below:
- Amount of hemoglobin and hematocrit decreased, measured by laboratory examinations, preoperatively, during, and on the day after the surgery.
- Vital changes such as hypotension, tachycardia, that require blood transfusion due to "more" bleeding during either the surgery or hospital stay after surgery.
- Usually, a shorter duration of bladder irrigation to clean blood in the urine during hospital stay after the surgery is required for "less" bleeding.
Participants who are eligible and willing to provide informed consent will undergo HoLEP. Preoperative, perioperative, and postoperative data will be collected without disclosing the participant or any personal data relating to the participant.
Participants will be grouped into two groups based on anesthesia type: general or spinal.
To answer the main question of this study, a power analysis was conducted, concluding that at least 320 participants are required (intention-to-treat population).
All collected data will be recorded and analyzed according to the proper statistical methods. Results will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | –Participants undergoing HoLEP under general anesthesia (intubation or laryngeal mask airway) |
| Spinal Anesthesia | – | –Participants undergoing HoLEP under spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients undergoing HoLEP for BPO.
Key inclusion criteria (3 listed)
- 18 years or older men who have BPO requiring surgical treatment.
- Participants who can give written informed consent.
- Having no more than 3 points for the American Society of Anesthesiologists (ASA) physical status classification scale (ASA 1 to 3).
Key exclusion criteria (6 listed)
- Absolute contraindication for spinal or general anesthesia
- History of previous surgery for prostate (e.g., surgery for prostate cancer, surgery for benign prostate obstruction)
- Uncorrected bleeding disorder (INR > 1.5)
- Participants who are not willing to give informed consent.
- Participants who have a proven urinary tract infection at the time of the surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemoglobin change
Time frame: First day after HoLEP is performed.
Difference between preoperative and postoperative hemoglobin levels (g/dL)
8 secondary outcomes
International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery
Time frame: At 3 months after HoLEP
Duration of hospitalization
Time frame: Postoperative second to seventh days after HoLEP.
Duration of catheterization
Time frame: From the time of HoLEP until the removal of the catheter.
Ratio of high grade complications
Time frame: From the time of HoLEP to 30 days after HoLEP.
Peak Urinary Flow (Qmax)
Time frame: At 3 months after HoLEP.
Post-void residual (PVR)
Time frame: At 3 months after HoLEP
Enucleation Efficiency
Time frame: From the start of HoLEP to the end of HoLEP (Operative time).
Ratio of intraoperative vasoactive medication requirement
Time frame: During the anesthesia for HoLEP
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 13 May 2026.
- Background: PubMed 39622439Haehn DA, Chadha RM, Porter SB, Pathak RA, Lyon TD, Hochwald AP, Dora CD. Same-day Discharge Following Holmium Laser Enucleation of the Prostate Under Spinal Anesthesia: A Propensity Score Matched Comparison With General Anesthesia. Urology. 2025 Feb;196:260-264. doi: 10.1016/j.urology.2024.11.058. Epub 2024 Nov 30.
- Background: PubMed 39382595Silvani C, Lucignani G, Bebi C, Turetti M, Ripa F, Zanetti SP, De Lorenzis E, Albo G, Longo F, Gadda F, Montanari E, Boeri L. General anesthesia is associated with lower perioperative bleeding and better functional outcomes than spinal anesthesia for endoscopic enucleation of the prostate: a single-center experience. World J Urol. 2024 Oct 9;42(1):569. doi: 10.1007/s00345-024-05271-z.
- Background: PubMed 34339752Westhofen T, Schott M, Keller P, Tamalunas A, Atzler M, Ebner B, Schultheiss M, Damm A, Kowalski C, Stief CG, Magistro G. Spinal Versus General Anesthesia for Holmium Laser Enucleation of the Prostate of High-risk Patients - A Propensity-score-matched-analysis. Urology. 2022 Jan;159:182-190. doi: 10.1016/j.urology.2021.04.078. Epub 2021 Jul 31.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations, including the Turkish Personal Data Protection Law (KVKK). Only aggregated, de-identified results will be reported in publications and presentations.
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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.
Murat Gulsen principal investigator
Ondokuz Mayıs University
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 Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms, run by Ondokuz Mayıs University 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 May 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 Murat Gulsen, Assistant Professor (+905062357421, mglotr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin change (time frame: First day after HoLEP is performed.). 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 NCT07585552, 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 13 May 2026.