Prostatic Hyperplasia, BenignNCT06849089
HoLEP: Learning Curve Analysis and Comparison With TURP
An observational study of Prostatic Hyperplasia, Benign and Prostatic Obstruction, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the outcomes of Holmium laser enucleation of the prostate (HoLEP) during both the learning and expert phases compared to transurethral resection of the prostate (TURP) in managing benign prostatic obstruction (BPO)-related lower urinary tract symptoms (LUTS). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign, Prostatic Obstruction
- What is being tested?
- Transurethral resection of prostate (TURP) and Holmium laser enucleation of prostate
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men >50 years of age with with lower urinary tract symptoms due to benign prostatic obstruction
Who may be able to join
- men >50 years of age
- presenting to our outpatient clinic with lower urinary tract symptoms attributed to benign prostatic obstruction
- indication for surgical treatment according to EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms
Who cannot join
- prior history of BPE surgery
- history of prostate cancer diagnosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, School of Medicine, Department of Urology
Istanbul, Pendik, 34890
About this study
Official title: Holmium Laser Enucleation of the Prostate: Learning Curve Analysis and Comparison With TURP
This study evaluates the outcomes of Holmium laser enucleation of the prostate (HoLEP) during both the learning and expert phases compared to transurethral resection of the prostate (TURP) in managing benign prostatic obstruction (BPO)-related lower urinary tract symptoms (LUTS). A prospective analysis of 200 men was conducted, dividing them into three groups: TURP (n=100), HoLEP during the learning curve (n=50), and HoLEP post-learning curve (n=50). Key outcomes assessed included the learning curve, perioperative safety, efficacy, functional recovery (IPSS, QoL, Qmax, PVR), surgical efficiency, and complication rates.
Read the detailed description
INTRODUCTION Benign prostatic obstruction (BPO) is a common urological issue that leads to lower urinary tract symptoms (LUTS). BPO is typically caused by benign prostatic hyperplasia (BPH), a histopathological condition that contributes to BPO through two mechanisms: a static component, where the enlarged prostate tissue obstructs urine flow, and a dynamic component, where increased smooth muscle tone increases resistance to urinary flow. These changes can lead to LUTS, recurrent urinary tract infections, urinary retention, and hematuria.
LUTS due to BPO can be managed through conservative measures, pharmacological treatments, or surgical interventions. While conservative and pharmacological therapies offer temporary, symptom-based relief, surgical treatments aim to provide a more permanent solution. Transurethral resection of the prostate (TURP) has been the gold standard surgical treatment for BPO for many years. However, advances in laser technology and surgical techniques have led to the increased popularity of anatomical endoscopic enucleation of the prostate (AEEP) using lasers such as holmium yttrium-aluminum-garnet (YAG), thulium YAG, or thulium fiber laser in the past decade. HoLEP is quite versatile in achieving complete anatomic enucleation of prostate adenoma which provides a permanent relief of obstruction and prevents re-growth of remnant prostatic tissue.
The scientific evidence supports the superiority of HoLEP compared to TURP, which has long been the gold standard. However, HoLEP is not an easy surgical method to learn and expertise. The learning curve is a critical consideration in HoLEP, which requires significant technical skill and experience to achieve proficiency and optimal outcomes. Perioperative and postoperative variables are evaluated to assess surgeon performance over consecutive cases.
The learning curve has been reported to be variable in different studies showing results between 25 to 80 cases in different cohorts.
In this study, we aimed to evaluate the outcomes of HoLEP during both the learning curve and expert periods, and to compare these results with the long-established gold standard, TURP.
METHODS Eligible patients were men >50 years of age presenting to our outpatient clinic with LUTS attributed to BPO with an indication for surgical treatment according to EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms 14 and who underwent either TURP or HoLEP. Patients with a prior history of BPE surgery, history of prostate cancer diagnosis were excluded.
Patients who underwent HoLEP by a single surgeon were included in the study. HoLEP patients were divided into 2 groups. The initial 50 patients who underwent HoLEP were considered to be operated in the learning curve of the surgeon. The subsequent 50 patients who underwent HoLEP by the same surgeon were considered to be operated in the expert phase of the surgeon. For comparison with the TURP outcomes, the last 100 patients who underwent bipolar TURP by the same surgeon were included in the study.
TURP patients were grouped as Group 1, initial 50 HoLEP patients were grouped as Group 2 and the subsequent 50 HoLEP patients were grouped as Group 3.
Patients who had a urinary tract infection prior to surgery were treated with appropriate antibiotics according to the preoperative urine culture. All the patients were scheduled for surgery when a sterile urine culture was obtained. All the patients received second generation cephalosporins as prophylactic antibiotics prior to surgery according to the local institution's Infections Committee protocol. Bridging with low molecular weight heparin was performed for all the patients who were under anticoagulant or antiaggregant therapies.
The primary objective was to evaluate the success rate. The evaluated parameters were scores on International Prostate Symptom Score (IPSS) and Quality of Life (QoL) questionnaire, maximum urinary flow rate (Qmax) on uroflowmetry and post-void residual urine volume (PVR) and operation duration, surgical efficiency and learning curve of HoLEP using the Cumulative Sum (CUSUM) analysis, for which, enucleation efficiency was used as evaluated parameters.
The secondary objective was to evaluate the safety profile by comparing the postoperative complications.
- Being tested
- Transurethral resection of prostate (TURP), Holmium laser enucleation of prostate
- Keywords
- prostate, prostatectomy, laser
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral resection of prostate (TURP)Procedure or surgery
The surgical intervention used to resect the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a hot loop shaped knife, operated by electrocautery, to cut the obstructing tissues from center towards periphery of the prostate until the prostatic capsule is reached.
Holmium laser enucleation of prostateProcedure or surgery
The surgical intervention used to enucleate the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a laser fiber to dissect the obstructing adenoma from the prostatic capsule starting from the plane in-between the capsule and the adenoma, meaning removal of tissues from periphery towards the center of the prostate.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - TURP patients | The last 100 patients who underwent bipolar TURP by the same surgeon who performed the HoLEP procedures in the study. Receives: Procedure: Transurethral resection of prostate (TURP) | |
| Group 2 - Initial HoLEP patients | The initial 50 patients who underwent HoLEP, who were considered to be operated in the learning curve of the surgeon. Receives: Procedure: Holmium laser enucleation of prostate | |
| Group 3 - Subsequent HoLEP patients | The subsequent 50 patients who underwent HoLEP, who were considered to be operated in the expert phase of the surgeon. Receives: Procedure: Holmium laser enucleation of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical efficiency
Surgical efficiency is defined as the resected / enucleated tissue volume in grams divided by total operation duration in minutes. The unit is g/min.
Measured: Perioperative/Periprocedural
Preoperative International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) is a standardized questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) associated with benign prostatic obstruction (BPO). It consists of seven questions evaluating urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) and one additional question on quality of life (QoL). Each symptom is rated on a scale from 0 to 5, with a total score ranging from 0 to 35, where higher scores indicate more severe symptoms.
Measured: Baseline
Postoperative International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) is a standardized questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) associated with benign prostatic obstruction (BPO). It consists of seven questions evaluating urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) and one additional question on quality of life (QoL). Each symptom is rated on a scale from 0 to 5, with a total score ranging from 0 to 35, where higher scores indicate more severe symptoms.
Measured: 6 months
Preoperative Quality of Life (QoL)
The Quality of Life (QoL) question at the end of the International Prostate Symptom Score (IPSS) assesses how bothersome a patient's urinary symptoms are in daily life. It asks:
Patients rate their response on a scale from 0 to 6, where 0 = delighted and 6 = terrible, providing a subjective measure of symptom impact on overall well-being.
Measured: Baseline
Postoperative Quality of Life (QoL)
The Quality of Life (QoL) question at the end of the International Prostate Symptom Score (IPSS) assesses how bothersome a patient's urinary symptoms are in daily life. It asks:
Patients rate their response on a scale from 0 to 6, where 0 = delighted and 6 = terrible, providing a subjective measure of symptom impact on overall well-being.
Measured: 6 months
Preoperative Maximum urinary flow rate (Qmax) on uroflowmetry
Maximum urinary flow rate (Qmax) is the highest flow rate of urine (measured in milliliters per second, mL/s) recorded during uroflowmetry, a non-invasive test that assesses urinary flow dynamics.
Measured: Baseline
PostoperativeMaximum urinary flow rate (Qmax) on uroflowmetry
Maximum urinary flow rate (Qmax) is the highest flow rate of urine (measured in milliliters per second, mL/s) recorded during uroflowmetry, a non-invasive test that assesses urinary flow dynamics.
Measured: 6 months
Operation duration
Operation duration refers to the total time taken to complete a surgical procedure, typically measured from the instrument insertion to the completion of the surgery. In the context of HoLEP and TURP, it includes steps such as enucleation (for HoLEP), resection (for TURP), hemostasis, and tissue morcellation (for HoLEP)
Measured: Perioperative/Periprocedural
Learning curve
The learning curve represents the time and number of cases required for a surgeon to achieve proficiency in a procedure, balancing efficiency, safety, and outcomes.
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Complication rate
Complication rate refers to the frequency of adverse events occurring during or after a surgical procedure, typically expressed as a percentage of total cases.
Measured: through study completion, an average of 6 months
Incontinence rate
Incontinence rate refers to the proportion of patients experiencing urinary incontinence after surgery, typically expressed as a percentage of total cases.
Measured: through study completion, an average of 6 months
Urethral stricture rate
Urethral stricture rate refers to the proportion of patients who develop a narrowing of the urethra following a surgical procedure, expressed as a percentage of total cases.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jun 2022
- Primary completion1 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Prostatic Hyperplasia, BenignStudies 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
- 200 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Emre Sener, Marmara University
- Investigators
- Tarık EMre Sener, Assoc. Prof., Principal investigator, Marmara University, School of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849089
- Sponsor's protocol ID
- MAR.UAD.0020
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request, study data can be shared without sharing participant identifying personal data.
Publications
Tang J, Yang JC, Zhang Y, Liu X, Zhang L, Wang Z, Li J, Luo Y, Xu J, Shi H. Does benign prostatic hyperplasia originate from the peripheral zone of the prostate? A preliminary study. BJU Int. 2007 Nov;100(5):1091-6. doi: 10.1111/j.1464-410X.2007.07081.x.
PubMed 17922787Chughtai B, Forde JC, Thomas DD, Laor L, Hossack T, Woo HH, Te AE, Kaplan SA. Benign prostatic hyperplasia. Nat Rev Dis Primers. 2016 May 5;2:16031. doi: 10.1038/nrdp.2016.31.
PubMed 27147135Dahm P, Brasure M, MacDonald R, Olson CM, Nelson VA, Fink HA, Rwabasonga B, Risk MC, Wilt TJ. Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis. Eur Urol. 2017 Apr;71(4):570-581. doi: 10.1016/j.eururo.2016.09.032. Epub 2016 Oct 4.
PubMed 27717522Plochocki A, King B. Medical Treatment of Benign Prostatic Hyperplasia. Urol Clin North Am. 2022 May;49(2):231-238. doi: 10.1016/j.ucl.2021.12.003. Epub 2022 Mar 22.
PubMed 35428429Cornu JN, Zantek P, Burtt G, Martin C, Martin A, Springate C, Chughtai B. Minimally Invasive Treatments for Benign Prostatic Obstruction: A Systematic Review and Network Meta-analysis. Eur Urol. 2023 Jun;83(6):534-547. doi: 10.1016/j.eururo.2023.02.028. Epub 2023 Mar 22.
PubMed 36964042Franco JVA, Jung JH, Imamura M, Borofsky M, Omar MI, Escobar Liquitay CM, Young S, Golzarian J, Veroniki AA, Garegnani L, Dahm P. Minimally invasive treatments for benign prostatic hyperplasia: a Cochrane network meta-analysis. BJU Int. 2022 Aug;130(2):142-156. doi: 10.1111/bju.15653. Epub 2021 Dec 6.
PubMed 34820997He W, Ding T, Niu Z, Hao C, Li C, Xu Z, Jing Y, Qin W. Reoperation after surgical treatment for benign prostatic hyperplasia: a systematic review. Front Endocrinol (Lausanne). 2023 Nov 9;14:1287212. doi: 10.3389/fendo.2023.1287212. eCollection 2023.
PubMed 38027158Magistro G, Schott M, Keller P, Tamalunas A, Atzler M, Stief CG, Westhofen T. Enucleation vs. Resection: A Matched-pair Analysis of TURP, HoLEP and Bipolar TUEP in Medium-sized Prostates. Urology. 2021 Aug;154:221-226. doi: 10.1016/j.urology.2021.04.004. Epub 2021 Apr 21.
PubMed 33891930Mavuduru RM, Mandal AK, Singh SK, Acharya N, Agarwal M, Garg S, Kumar S. Comparison of HoLEP and TURP in terms of efficacy in the early postoperative period and perioperative morbidity. Urol Int. 2009;82(2):130-5. doi: 10.1159/000200786. Epub 2009 Mar 19.
PubMed 19321996Chavali JSS, Rivera ME, Lingeman JE. HoLEP Learning Curve-Resident Perspective: Survey of Senior Residents from High-Volume Tertiary Center. J Endourol. 2024 Sep;38(9):977-981. doi: 10.1089/end.2024.0054. Epub 2024 Jul 4.
PubMed 38904168Wenk MJ, Hartung FO, Egen L, Netsch C, Kosiba M, Grune B, Herrmann J. The long-term learning curve of holmium laser enucleation of the prostate (HoLEP) in the en-bloc technique: a single surgeon series of 500 consecutive cases. World J Urol. 2024 Jul 24;42(1):436. doi: 10.1007/s00345-024-05097-9.
PubMed 39046537Martinez-Salas AJ, Garcia-Rivera OU, Reyna-Blanco I, Jimenez-Garcia AD, Rosas-Hernandez H. Adequate Mentorship Program for Holmium Laser Enucleation of the Prostate (HoLEP) Leads to Satisfactory Short-Term Outcomes in the Early Learning Curve of Young Urologists: First-Year Outcomes of a Newly Established Mentorship Training in Mexico. Cureus. 2023 Jul 12;15(7):e41756. doi: 10.7759/cureus.41756. eCollection 2023 Jul.
PubMed 37575804Baron M, Nouhaud FX, Delcourt C, Grise P, Pfister C, Cornu JN, Sibert L. [HoLEP learning curve: Toward a standardised formation and a team strategy]. Prog Urol. 2016 Sep;26(9):492-9. doi: 10.1016/j.purol.2016.08.002. Epub 2016 Sep 7. French.
PubMed 27614386
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Enucleation of the Prostate: Learning Curve Analysis and Comparison With TURP
- ClinicalTrials.gov ID
- NCT06849089
- Acronym / sponsor ID
- MAR.UAD.0020
- Keywords
- prostate, prostatectomy, laser
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Feb 2025 (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 evaluates the outcomes of Holmium laser enucleation of the prostate (HoLEP) during both the learning and expert phases compared to transurethral resection of the prostate (TURP) in managing benign prostatic obstruction (BPO)-related lower urinary tract symptoms (LUTS). A prospective analysis of 200 men was conducted, dividing them into three groups: TURP (n=100), HoLEP during the learning curve (n=50), and HoLEP post-learning curve (n=50). Key outcomes assessed included the learning curve, perioperative safety, efficacy, functional recovery (IPSS, QoL, Qmax, PVR), surgical efficiency, and complication rates.
Detailed description
INTRODUCTION Benign prostatic obstruction (BPO) is a common urological issue that leads to lower urinary tract symptoms (LUTS). BPO is typically caused by benign prostatic hyperplasia (BPH), a histopathological condition that contributes to BPO through two mechanisms: a static component, where the enlarged prostate tissue obstructs urine flow, and a dynamic component, where increased smooth muscle tone increases resistance to urinary flow. These changes can lead to LUTS, recurrent urinary tract infections, urinary retention, and hematuria.
LUTS due to BPO can be managed through conservative measures, pharmacological treatments, or surgical interventions. While conservative and pharmacological therapies offer temporary, symptom-based relief, surgical treatments aim to provide a more permanent solution. Transurethral resection of the prostate (TURP) has been the gold standard surgical treatment for BPO for many years. However, advances in laser technology and surgical techniques have led to the increased popularity of anatomical endoscopic enucleation of the prostate (AEEP) using lasers such as holmium yttrium-aluminum-garnet (YAG), thulium YAG, or thulium fiber laser in the past decade. HoLEP is quite versatile in achieving complete anatomic enucleation of prostate adenoma which provides a permanent relief of obstruction and prevents re-growth of remnant prostatic tissue.
The scientific evidence supports the superiority of HoLEP compared to TURP, which has long been the gold standard. However, HoLEP is not an easy surgical method to learn and expertise. The learning curve is a critical consideration in HoLEP, which requires significant technical skill and experience to achieve proficiency and optimal outcomes. Perioperative and postoperative variables are evaluated to assess surgeon performance over consecutive cases.
The learning curve has been reported to be variable in different studies showing results between 25 to 80 cases in different cohorts.
In this study, we aimed to evaluate the outcomes of HoLEP during both the learning curve and expert periods, and to compare these results with the long-established gold standard, TURP.
METHODS Eligible patients were men >50 years of age presenting to our outpatient clinic with LUTS attributed to BPO with an indication for surgical treatment according to EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms 14 and who underwent either TURP or HoLEP. Patients with a prior history of BPE surgery, history of prostate cancer diagnosis were excluded.
Patients who underwent HoLEP by a single surgeon were included in the study. HoLEP patients were divided into 2 groups. The initial 50 patients who underwent HoLEP were considered to be operated in the learning curve of the surgeon. The subsequent 50 patients who underwent HoLEP by the same surgeon were considered to be operated in the expert phase of the surgeon. For comparison with the TURP outcomes, the last 100 patients who underwent bipolar TURP by the same surgeon were included in the study.
TURP patients were grouped as Group 1, initial 50 HoLEP patients were grouped as Group 2 and the subsequent 50 HoLEP patients were grouped as Group 3.
Patients who had a urinary tract infection prior to surgery were treated with appropriate antibiotics according to the preoperative urine culture. All the patients were scheduled for surgery when a sterile urine culture was obtained. All the patients received second generation cephalosporins as prophylactic antibiotics prior to surgery according to the local institution's Infections Committee protocol. Bridging with low molecular weight heparin was performed for all the patients who were under anticoagulant or antiaggregant therapies.
The primary objective was to evaluate the success rate. The evaluated parameters were scores on International Prostate Symptom Score (IPSS) and Quality of Life (QoL) questionnaire, maximum urinary flow rate (Qmax) on uroflowmetry and post-void residual urine volume (PVR) and operation duration, surgical efficiency and learning curve of HoLEP using the Cumulative Sum (CUSUM) analysis, for which, enucleation efficiency was used as evaluated parameters.
The secondary objective was to evaluate the safety profile by comparing the postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - TURP patients | – | Procedure: Transurethral resection of prostate (TURP)The last 100 patients who underwent bipolar TURP by the same surgeon who performed the HoLEP procedures in the study. |
| Group 2 - Initial HoLEP patients | – | Procedure: Holmium laser enucleation of prostateThe initial 50 patients who underwent HoLEP, who were considered to be operated in the learning curve of the surgeon. |
| Group 3 - Subsequent HoLEP patients | – | Procedure: Holmium laser enucleation of prostateThe subsequent 50 patients who underwent HoLEP, who were considered to be operated in the expert phase of the surgeon. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men >50 years of age with with lower urinary tract symptoms due to benign prostatic obstruction
Key inclusion criteria (3 listed)
- men >50 years of age
- presenting to our outpatient clinic with lower urinary tract symptoms attributed to benign prostatic obstruction
- indication for surgical treatment according to EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms
Key exclusion criteria (2 listed)
- prior history of BPE surgery
- history of prostate cancer diagnosis
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 |
|---|---|---|
| Transurethral resection of prostate (TURP)The surgical intervention used to resect the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a hot loop shaped knife, operated by electrocautery, to cut the obstructing tissues from center towards periphery of the prostate until the prostatic capsule is reached. | Procedure or surgery | Group 1 - TURP patients |
| Holmium laser enucleation of prostateThe surgical intervention used to enucleate the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a laser fiber to dissect the obstructing adenoma from the prostatic capsule starting from the plane in-between the capsule and the adenoma, meaning removal of tissues from periphery towards the center of the prostate. | Procedure or surgery | Group 2 - Initial HoLEP patients, Group 3 - Subsequent HoLEP patients |
Primary outcome
Surgical efficiency
Time frame: Perioperative/Periprocedural
Surgical efficiency is defined as the resected / enucleated tissue volume in grams divided by total operation duration in minutes. The unit is g/min.
Preoperative International Prostate Symptom Score (IPSS)
Time frame: Baseline
The International Prostate Symptom Score (IPSS) is a standardized questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) associated with benign prostatic obstruction (BPO). It consists of seven questions evaluating urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) and one additional question on quality of life (QoL). Each symptom is rated on a scale from 0 to 5, with a total score ranging from 0 to 35, where higher scores indicate more severe symptoms.
Postoperative International Prostate Symptom Score (IPSS)
Time frame: 6 months
The International Prostate Symptom Score (IPSS) is a standardized questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) associated with benign prostatic obstruction (BPO). It consists of seven questions evaluating urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) and one additional question on quality of life (QoL). Each symptom is rated on a scale from 0 to 5, with a total score ranging from 0 to 35, where higher scores indicate more severe symptoms.
Preoperative Quality of Life (QoL)
Time frame: Baseline
The Quality of Life (QoL) question at the end of the International Prostate Symptom Score (IPSS) assesses how bothersome a patient's urinary symptoms are in daily life. It asks: Patients rate their response on a scale from 0 to 6, where 0 = delighted and 6 = terrible, providing a subjective measure of symptom impact on overall well-being.
Postoperative Quality of Life (QoL)
Time frame: 6 months
The Quality of Life (QoL) question at the end of the International Prostate Symptom Score (IPSS) assesses how bothersome a patient's urinary symptoms are in daily life. It asks: Patients rate their response on a scale from 0 to 6, where 0 = delighted and 6 = terrible, providing a subjective measure of symptom impact on overall well-being.
Preoperative Maximum urinary flow rate (Qmax) on uroflowmetry
Time frame: Baseline
Maximum urinary flow rate (Qmax) is the highest flow rate of urine (measured in milliliters per second, mL/s) recorded during uroflowmetry, a non-invasive test that assesses urinary flow dynamics.
PostoperativeMaximum urinary flow rate (Qmax) on uroflowmetry
Time frame: 6 months
Maximum urinary flow rate (Qmax) is the highest flow rate of urine (measured in milliliters per second, mL/s) recorded during uroflowmetry, a non-invasive test that assesses urinary flow dynamics.
Operation duration
Time frame: Perioperative/Periprocedural
Operation duration refers to the total time taken to complete a surgical procedure, typically measured from the instrument insertion to the completion of the surgery. In the context of HoLEP and TURP, it includes steps such as enucleation (for HoLEP), resection (for TURP), hemostasis, and tissue morcellation (for HoLEP)
Learning curve
Time frame: through study completion, an average of 6 months
The learning curve represents the time and number of cases required for a surgeon to achieve proficiency in a procedure, balancing efficiency, safety, and outcomes.
3 secondary outcomes
Complication rate
Time frame: through study completion, an average of 6 months
Incontinence rate
Time frame: through study completion, an average of 6 months
Urethral stricture rate
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 17922787Tang J, Yang JC, Zhang Y, Liu X, Zhang L, Wang Z, Li J, Luo Y, Xu J, Shi H. Does benign prostatic hyperplasia originate from the peripheral zone of the prostate? A preliminary study. BJU Int. 2007 Nov;100(5):1091-6. doi: 10.1111/j.1464-410X.2007.07081.x.
- Background: PubMed 27147135Chughtai B, Forde JC, Thomas DD, Laor L, Hossack T, Woo HH, Te AE, Kaplan SA. Benign prostatic hyperplasia. Nat Rev Dis Primers. 2016 May 5;2:16031. doi: 10.1038/nrdp.2016.31.
- Background: PubMed 27717522Dahm P, Brasure M, MacDonald R, Olson CM, Nelson VA, Fink HA, Rwabasonga B, Risk MC, Wilt TJ. Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis. Eur Urol. 2017 Apr;71(4):570-581. doi: 10.1016/j.eururo.2016.09.032. Epub 2016 Oct 4.
- Background: PubMed 35428429Plochocki A, King B. Medical Treatment of Benign Prostatic Hyperplasia. Urol Clin North Am. 2022 May;49(2):231-238. doi: 10.1016/j.ucl.2021.12.003. Epub 2022 Mar 22.
- Background: PubMed 36964042Cornu JN, Zantek P, Burtt G, Martin C, Martin A, Springate C, Chughtai B. Minimally Invasive Treatments for Benign Prostatic Obstruction: A Systematic Review and Network Meta-analysis. Eur Urol. 2023 Jun;83(6):534-547. doi: 10.1016/j.eururo.2023.02.028. Epub 2023 Mar 22.
- Background: PubMed 34820997Franco JVA, Jung JH, Imamura M, Borofsky M, Omar MI, Escobar Liquitay CM, Young S, Golzarian J, Veroniki AA, Garegnani L, Dahm P. Minimally invasive treatments for benign prostatic hyperplasia: a Cochrane network meta-analysis. BJU Int. 2022 Aug;130(2):142-156. doi: 10.1111/bju.15653. Epub 2021 Dec 6.
- Background: PubMed 38027158He W, Ding T, Niu Z, Hao C, Li C, Xu Z, Jing Y, Qin W. Reoperation after surgical treatment for benign prostatic hyperplasia: a systematic review. Front Endocrinol (Lausanne). 2023 Nov 9;14:1287212. doi: 10.3389/fendo.2023.1287212. eCollection 2023.
- Background: PubMed 33891930Magistro G, Schott M, Keller P, Tamalunas A, Atzler M, Stief CG, Westhofen T. Enucleation vs. Resection: A Matched-pair Analysis of TURP, HoLEP and Bipolar TUEP in Medium-sized Prostates. Urology. 2021 Aug;154:221-226. doi: 10.1016/j.urology.2021.04.004. Epub 2021 Apr 21.
- Background: PubMed 19321996Mavuduru RM, Mandal AK, Singh SK, Acharya N, Agarwal M, Garg S, Kumar S. Comparison of HoLEP and TURP in terms of efficacy in the early postoperative period and perioperative morbidity. Urol Int. 2009;82(2):130-5. doi: 10.1159/000200786. Epub 2009 Mar 19.
- Background: PubMed 38904168Chavali JSS, Rivera ME, Lingeman JE. HoLEP Learning Curve-Resident Perspective: Survey of Senior Residents from High-Volume Tertiary Center. J Endourol. 2024 Sep;38(9):977-981. doi: 10.1089/end.2024.0054. Epub 2024 Jul 4.
- Background: PubMed 39046537Wenk MJ, Hartung FO, Egen L, Netsch C, Kosiba M, Grune B, Herrmann J. The long-term learning curve of holmium laser enucleation of the prostate (HoLEP) in the en-bloc technique: a single surgeon series of 500 consecutive cases. World J Urol. 2024 Jul 24;42(1):436. doi: 10.1007/s00345-024-05097-9.
- Background: PubMed 37575804Martinez-Salas AJ, Garcia-Rivera OU, Reyna-Blanco I, Jimenez-Garcia AD, Rosas-Hernandez H. Adequate Mentorship Program for Holmium Laser Enucleation of the Prostate (HoLEP) Leads to Satisfactory Short-Term Outcomes in the Early Learning Curve of Young Urologists: First-Year Outcomes of a Newly Established Mentorship Training in Mexico. Cureus. 2023 Jul 12;15(7):e41756. doi: 10.7759/cureus.41756. eCollection 2023 Jul.
- Individual participant dataSharing planned: No. Upon request, study data can be shared without sharing participant identifying personal data.
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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. This study is not recruiting at the moment.
Tarık EMre Sener, Assoc. Prof. principal investigator
Marmara University, School of Medicine, Department of Urology
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 and Prostatic Obstruction, run by Marmara 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 2 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: finished, as of the sponsor's last update on 28 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical efficiency (time frame: Perioperative/Periprocedural). The study lists 9 primary outcomes in all. 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 NCT06849089, which also lists 13 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 28 Feb 2025.