Benign Prostate Obstruction (BPO)NCT07591688
Enucleation Ratio as a Novel Predictor of Symptomatic Improvement After HoLEP
An observational study of Benign Prostate Obstruction (BPO), run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine whether the rate of prostate tissue removed during surgery relative to the preoperative total prostate volume (referred to as the "enucleation ratio") predicts symptomatic improvement 3 months after HoLEP. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostate Obstruction (BPO)
- What is being tested?
- Holmium laser enucleation of prostate (HoLEP)
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 30 Mar 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: Adult males with moderate to severe lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) who are scheduled to undergo holmium laser enucleation of the prostate (HoLEP) at participating urology centers across multiple institutions.
Who may be able to join
- Men aged 18 years pr older who are planned to undergo HoLEP.
- Participants who are willing to give informed consent.
- Participants who have moderate to severe LUTS (referring to IPSS score 8 points or more).
- No history of previous prostate or urethral surgery.
Who cannot join
- Unwillingness to provide informed consent.
- Unwillingness to provide contact information or unreachability during follow-up periods.
- Incidental diagnosis of a urogenital malignancy requiring primary treatment after enrollment (e.g., bladder tumor, renal cell carcinoma, testicular tumor).
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: Predictive Value of Enucleation Ratio for Symptomatic Improvement After HoLEP: A Multicenter Prospective Cohort Study
The goal of this observational study is to determine whether the rate of prostate tissue removed during surgery relative to the preoperative total prostate volume (referred to as the "enucleation ratio") predicts symptomatic improvement 3 months after HoLEP. The main question it aims to answer is:
- What is the minimum enucleation ratio required to achieve clinically important symptomatic improvement? (Symptomatic improvement is referred to as a threshold of having an International Prostate Symptom Score (IPSS) lower than 8 points, which is determined by the American Urological Association (AUA) and European Association of Urology(EAU)).
Read the detailed description
HoLEP has become a widespread and well-practiced surgical method for benign prostate obstruction (BPO). The method is known to have a steep learning curve, and mastery requires extensive practice. Treatment efficiency depends on removing the obstruction while protecting the delicate external urethral sphincter.
However, it's still unclear which pre-operative and intra-operative factors affect surgical outcome. Some authors have already contributed to this subject; in fact, changes in peak urinary flow rate, IPSS-QoL, and the absence of stress urinary incontinence and high-grade complications are among the agreed-upon criteria for successful surgery. As the main purpose of HoLEP, or any other benign prostate surgeries, is to remove obstruction, the more adenoma tissue to be removed, the less obstruction there will be. Yet not anatomic, but there's a surgical capsule around the prostate, which can stretch, causing residual tissue to obstruct the urethral passage. Leaving residual adenoma tissue is not uncommon and may affect the efficacy of HoLEP, particularly given the steep learning curve of the procedure. Therefore, it may be reasonable for one to consider that the higher the ratio of adenoma tissue removed, the better the outcomes could be.
Enucleation ratio is a novel parameter that has not been investigated previously in this context and is calculated by dividing the weight (grams) of morcellated adenoma tissue by the preoperatively measured prostate volume (mL). The density of the prostate is widely accepted as 1 gram per milliliter, so the enucleation ratio has no units.
Identifying a minimum enucleation ratio associated with clinically meaningful symptomatic improvement could provide surgeons with a measurable intraoperative target, potentially improving procedural standardization and patient counseling - particularly during the learning curve of HoLEP.
- Conditions
- Benign Prostate Obstruction (BPO)
- Being tested
- Holmium laser enucleation of prostate (HoLEP)
- Keywords
- HoLEP, BPO, LUTS, Enucleation Ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium laser enucleation of prostate (HoLEP)Procedure or surgery
HoLEP is a widespread and minimally invasive surgical method to treat LUTS caused by BPO. En-bloc or tri-lobar technique will be performed according to the surgeon's preference during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| HoLEP | Males older than 18 years with lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) who are planned to undergo holmium laser enucleation of the prostate (HoLEP) at participating centers. Receives: Procedure: Holmium laser enucleation of prostate (HoLEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of mild symptom category (IPSS < 8) at 3 months after HoLEP
The International Prostate Symptom Score (IPSS) is a validated questionnaire for lower urinary tract symptoms (LUTS).
An IPSS score of 1-7 indicates mild LUTS, 8-19 moderate, and 20-35 severe LUTS, according to both the AUA and the EAU.
Achievement of mild LUTS (IPSS < 8) is widely accepted as a satisfactory surgical outcome. Therefore, the primary outcome was set as binary (IPSS < 8 or otherwise).
3 months as a postoperative period is preferred because relief of irritative symptoms requires time, and the 3-month timepoint is widely adopted in the HoLEP literature as the standard assessment period for functional outcomes, allowing sufficient recovery from transient postoperative irritative symptoms while reflecting stable surgical results.
Measured: 3 months after HoLEP
Secondary outcomes (4)
QoL score reduction of at least 1 point from the baseline at 3 months after HoLEP
The Quality of Life (QoL) score is a single validated question included in the IPSS questionnaire that assesses how much lower urinary tract symptoms affect a patient's daily life, scored from 0 (delighted) to 6 (terrible).
3 months as a postoperative period is preferred because relief of irritative symptoms requires time, and the 3-month timepoint is widely adopted in the HoLEP literature as the standard assessment period for functional outcomes, allowing sufficient recovery from transient postoperative irritative symptoms while reflecting stable surgical results.
Measured: 3 months after HoLEP
Qmax > 15 mL/s achievement rate at 3 months after HoLEP
Maximum urinary flow rate (Qmax) is an objective measure of voiding efficiency assessed by uroflowmetry. A Qmax of 15 mL/s is widely accepted as the threshold distinguishing normal from impaired voiding, as referenced in EAU guidelines for non-neurogenic male LUTS.
3 months as a postoperative period is preferred because relief of irritative symptoms requires time, and the 3-month timepoint is widely adopted in the HoLEP literature as the standard assessment period for functional outcomes, allowing sufficient recovery from transient postoperative irritative symptoms while reflecting stable surgical results.
Measured: 3 months after HoLEP
Ratio of high grade complications (Clavien-Dindo grade III or higher) within 1 month after HoLEP
In large HoLEP series, 30-day postoperative complications have been consistently reported using the Clavien-Dindo classification.
Measured: Within 1 month following HoLEP
Ratio of stress urinary incontinence at 3 months after HoLEP
Stress urinary incontinence, whether transient or permanent, is a well-recognized complication of HoLEP, and its absence at 3 months postoperatively is among the criteria for Trifecta achievement as defined in the literature.
Measured: 3 months after HoLEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Mar 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 Prostate Obstruction (BPO)Studies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Prospective
- Enrolment
- 400 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, Assistant Professor, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591688
- Sponsor's protocol ID
- MIUS.2026.003
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 19 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
Alkan I, Ozveri H, Akin Y, Ipekci T, Alican Y. Holmium laser enucleation of the prostate: surgical, functional, and quality-of-life outcomes upon extended follow-up. Int Braz J Urol. 2016 Mar-Apr;42(2):293-301. doi: 10.1590/S1677-5538.IBJU.2014.0561.
PubMed 27256184Grosso AA, Di Maida F, Nardoni S, Salvi M, Giudici S, Lambertini L, Cadenar A, Tellini R, Cocci A, Mari A, Minervini A, Tuccio A. Patterns and Predictors of Optimal Surgical and Functional Outcomes after Holmium Laser Enucleation of the Prostate (HoLEP): Introducing the Concept of "Trifecta". World J Mens Health. 2023 Jul;41(3):603-611. doi: 10.5534/wjmh.220042. Epub 2023 Jan 1.
PubMed 36593708Jeong CW, Oh JK, Cho MC, Bae JB, Oh SJ. Enucleation ratio efficacy might be a better predictor to assess learning curve of holmium laser enucleation of the prostate. Int Braz J Urol. 2012 May-Jun;38(3):362-71; discussions 372. doi: 10.1590/s1677-55382012000300009.
PubMed 22765867
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Enucleation Ratio for Symptomatic Improvement After HoLEP: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07591688
- Acronym / sponsor ID
- MIUS.2026.003
- Conditions
- Benign Prostate Obstruction (BPO)
- Keywords
- HoLEP, BPO, LUTS, Enucleation Ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 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.
The goal of this observational study is to determine whether the rate of prostate tissue removed during surgery relative to the preoperative total prostate volume (referred to as the "enucleation ratio") predicts symptomatic improvement 3 months after HoLEP. The main question it aims to answer is:
- What is the minimum enucleation ratio required to achieve clinically important symptomatic improvement? (Symptomatic improvement is referred to as a threshold of having an International Prostate Symptom Score (IPSS) lower than 8 points, which is determined by the American Urological Association (AUA) and European Association of Urology(EAU)).
Detailed description
HoLEP has become a widespread and well-practiced surgical method for benign prostate obstruction (BPO). The method is known to have a steep learning curve, and mastery requires extensive practice. Treatment efficiency depends on removing the obstruction while protecting the delicate external urethral sphincter.
However, it's still unclear which pre-operative and intra-operative factors affect surgical outcome. Some authors have already contributed to this subject; in fact, changes in peak urinary flow rate, IPSS-QoL, and the absence of stress urinary incontinence and high-grade complications are among the agreed-upon criteria for successful surgery. As the main purpose of HoLEP, or any other benign prostate surgeries, is to remove obstruction, the more adenoma tissue to be removed, the less obstruction there will be. Yet not anatomic, but there's a surgical capsule around the prostate, which can stretch, causing residual tissue to obstruct the urethral passage. Leaving residual adenoma tissue is not uncommon and may affect the efficacy of HoLEP, particularly given the steep learning curve of the procedure. Therefore, it may be reasonable for one to consider that the higher the ratio of adenoma tissue removed, the better the outcomes could be.
Enucleation ratio is a novel parameter that has not been investigated previously in this context and is calculated by dividing the weight (grams) of morcellated adenoma tissue by the preoperatively measured prostate volume (mL). The density of the prostate is widely accepted as 1 gram per milliliter, so the enucleation ratio has no units.
Identifying a minimum enucleation ratio associated with clinically meaningful symptomatic improvement could provide surgeons with a measurable intraoperative target, potentially improving procedural standardization and patient counseling - particularly during the learning curve of HoLEP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HoLEP | – | Procedure: Holmium laser enucleation of prostate (HoLEP)Males older than 18 years with lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) who are planned to undergo holmium laser enucleation of the prostate (HoLEP) at participating centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males with moderate to severe lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) who are scheduled to undergo holmium laser enucleation of the prostate (HoLEP) at participating urology centers across multiple institutions.
Key inclusion criteria (4 listed)
- Men aged 18 years pr older who are planned to undergo HoLEP.
- Participants who are willing to give informed consent.
- Participants who have moderate to severe LUTS (referring to IPSS score 8 points or more).
- No history of previous prostate or urethral surgery.
Key exclusion criteria (3 listed)
- Unwillingness to provide informed consent.
- Unwillingness to provide contact information or unreachability during follow-up periods.
- Incidental diagnosis of a urogenital malignancy requiring primary treatment after enrollment (e.g., bladder tumor, renal cell carcinoma, testicular tumor).
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 |
|---|---|---|
| Holmium laser enucleation of prostate (HoLEP)HoLEP is a widespread and minimally invasive surgical method to treat LUTS caused by BPO. En-bloc or tri-lobar technique will be performed according to the surgeon's preference during the procedure. | Procedure or surgery | HoLEP |
Primary outcome
Achievement of mild symptom category (IPSS < 8) at 3 months after HoLEP
Time frame: 3 months after HoLEP
The International Prostate Symptom Score (IPSS) is a validated questionnaire for lower urinary tract symptoms (LUTS). An IPSS score of 1-7 indicates mild LUTS, 8-19 moderate, and 20-35 severe LUTS, according to both the AUA and the EAU. Achievement of mild LUTS (IPSS < 8) is widely accepted as a satisfactory surgical outcome. Therefore, the primary outcome was set as binary (IPSS < 8 or otherwise). 3 months as a postoperative period is preferred because relief of irritative symptoms requires time, and the 3-month timepoint is widely adopted in the HoLEP literature as the standard assessment period for functional outcomes, allowing sufficient recovery from transient postoperative irritative symptoms while reflecting stable surgical results.
4 secondary outcomes
QoL score reduction of at least 1 point from the baseline at 3 months after HoLEP
Time frame: 3 months after HoLEP
Qmax > 15 mL/s achievement rate at 3 months after HoLEP
Time frame: 3 months after HoLEP
Ratio of high grade complications (Clavien-Dindo grade III or higher) within 1 month after HoLEP
Time frame: Within 1 month following HoLEP
Ratio of stress urinary incontinence at 3 months after HoLEP
Time frame: 3 months after 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 19 May 2026.
- Background: PubMed 27256184Alkan I, Ozveri H, Akin Y, Ipekci T, Alican Y. Holmium laser enucleation of the prostate: surgical, functional, and quality-of-life outcomes upon extended follow-up. Int Braz J Urol. 2016 Mar-Apr;42(2):293-301. doi: 10.1590/S1677-5538.IBJU.2014.0561.
- Background: PubMed 36593708Grosso AA, Di Maida F, Nardoni S, Salvi M, Giudici S, Lambertini L, Cadenar A, Tellini R, Cocci A, Mari A, Minervini A, Tuccio A. Patterns and Predictors of Optimal Surgical and Functional Outcomes after Holmium Laser Enucleation of the Prostate (HoLEP): Introducing the Concept of "Trifecta". World J Mens Health. 2023 Jul;41(3):603-611. doi: 10.5534/wjmh.220042. Epub 2023 Jan 1.
- Background: PubMed 22765867Jeong CW, Oh JK, Cho MC, Bae JB, Oh SJ. Enucleation ratio efficacy might be a better predictor to assess learning curve of holmium laser enucleation of the prostate. Int Braz J Urol. 2012 May-Jun;38(3):362-71; discussions 372. doi: 10.1590/s1677-55382012000300009.
- 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, Assistant Professor 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 Prostate Obstruction (BPO), 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 4 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: opening soon, as of the sponsor's last update on 19 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?
Achievement of mild symptom category (IPSS < 8) at 3 months after HoLEP (time frame: 3 months after HoLEP). 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 NCT07591688, 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 19 May 2026.