Clinical trial NCT06849089: HoLEP: Learning Curve Analysis and Comparison With TURP
Official title: Holmium Laser Enucleation of the Prostate: Learning Curve Analysis and Comparison With TURP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia, Benign
Prostatic Obstruction
Keywords: prostate
prostatectomy
laser
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 200
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men \>50 years of age with with lower urinary tract symptoms due to benign prostatic obstruction

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical efficiency
timeFrame: Perioperative/Periprocedural
measure: Preoperative International Prostate Symptom Score (IPSS)
timeFrame: Baseline
measure: Postoperative International Prostate Symptom Score (IPSS)
timeFrame: 6 months
measure: Preoperative Quality of Life (QoL)
timeFrame: Baseline
measure: Postoperative Quality of Life (QoL)
timeFrame: 6 months
measure: Preoperative Maximum urinary flow rate (Qmax) on uroflowmetry
timeFrame: Baseline
measure: PostoperativeMaximum urinary flow rate (Qmax) on uroflowmetry
timeFrame: 6 months
measure: Operation duration
timeFrame: Perioperative/Periprocedural
measure: Learning curve
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Complication rate
timeFrame: through study completion, an average of 6 months
measure: Incontinence rate
timeFrame: through study completion, an average of 6 months
measure: Urethral stricture rate
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, School of Medicine, Department of Urology
state: Pendik
Study officials:
affiliation: Marmara University, School of Medicine, Department of Urology
name: Tarık EMre Sener, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
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