HoLEP: Learning Curve Analysis and Comparison With TURP

Completed

• Conditions: Prostatic Hyperplasia, Benign; Prostatic Obstruction

• Registration Number: NCT06849089
• Lead Sponsor: Marmara University

Brief 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). 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 Timeline

• Study Start: 2022-06-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-30
• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preoperative Quality of Life (QoL)	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.
Surgical efficiency	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)	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)	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.
Postoperative Quality of Life (QoL)	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Complication rate	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.
Incontinence rate	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.
Urethral stricture rate	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.

Trial Locations

Locations (1)

Marmara University, School of Medicine, Department of Urology; 🇹🇷 Istanbul, Pendik, Turkey