HoLEP: Learning Curve Analysis and Comparison With TURP

NCT06849089 | Completed

• 1 other identifier: MAR.UAD.0020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia, Benign; Prostatic Obstruction

Keywords

prostate; prostatectomy; laser

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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.

  through study completion, an average of 6 months

Secondary Outcomes (3)

• Complication rate

  through study completion, an average of 6 months

• Incontinence rate

  through study completion, an average of 6 months

• Urethral stricture rate

  through study completion, an average of 6 months

Study Arms (3)

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)

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

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

Interventions

Transurethral resection of prostate (TURP) PROCEDURE

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 1 - TURP patients

Holmium laser enucleation of prostate PROCEDURE

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 2 - Initial HoLEP patients; Group 3 - Subsequent HoLEP patients

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, School of Medicine, Department of Urology

Istanbul, Pendik, 34890, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 17922787 BACKGROUND

• Chughtai 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.

  PMID: 27147135 BACKGROUND

• Dahm 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.

  PMID: 27717522 BACKGROUND

• Plochocki 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.

  PMID: 35428429 BACKGROUND

• Cornu 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.

  PMID: 36964042 BACKGROUND

• Franco 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.

  PMID: 34820997 BACKGROUND

• He 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.

  PMID: 38027158 BACKGROUND

• Magistro 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.

  PMID: 33891930 BACKGROUND

• Mavuduru 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.

  PMID: 19321996 BACKGROUND

• Chavali 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.

  PMID: 38904168 BACKGROUND

• Wenk 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.

  PMID: 39046537 BACKGROUND

• Martinez-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.

  PMID: 37575804 BACKGROUND

• Baron 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.

  PMID: 27614386 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Tarık EMre Sener, Assoc. Prof.

  Marmara University, School of Medicine, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 27, 2025
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 30, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)