HoLEP: Learning Curve Analysis and Comparison With TURP

February 26, 2025 updated by: Tarik Emre Sener, Marmara University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Pendik
      • Istanbul, Pendik, Turkey, 34890
        • Marmara University, School of Medicine, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men >50 years of age with with lower urinary tract symptoms due to benign prostatic obstruction

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • prior history of BPE surgery
  • history of prostate cancer diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 - TURP patients
The last 100 patients who underwent bipolar TURP by the same surgeon who performed the HoLEP procedures in the study.
Procedure: 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.
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.
Procedure: Holmium laser enucleation of prostate
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.
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.
Procedure: Holmium laser enucleation of prostate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Perioperative/Periprocedural
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.
Baseline
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.
6 months
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.
Baseline
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.
6 months
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.
Baseline
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.
6 months
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)
Perioperative/Periprocedural
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.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: through study completion, an average of 6 months
Complication rate refers to the frequency of adverse events occurring during or after a surgical procedure, typically expressed as a percentage of total cases.
through study completion, an average of 6 months
Incontinence rate
Time Frame: through study completion, an average of 6 months
Incontinence rate refers to the proportion of patients experiencing urinary incontinence after surgery, typically expressed as a percentage of total cases.
through study completion, an average of 6 months
Urethral stricture rate
Time Frame: through study completion, an average of 6 months
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.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Tarık EMre Sener, Assoc. Prof., Marmara University, School of Medicine, Department of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR.UAD.0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Upon request, study data can be shared without sharing participant identifying personal data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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