Predictors of Trifecta Achievement After HoLEP

NCT07429994 | Not Yet Recruiting DMC

• 1 other identifier: MIUS.2026.001
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment option for men experiencing bothersome lower urinary tract symptoms due to an enlarged prostate. Researchers predict that specific participant or operator-dependent conditions before or during HoLEP may influence the trifecta outcome, based on similar studies. Therefore, the aim of this study is to understand what these conditions are. Trifecta success indicates a high-quality surgery based on three essential criteria: the treatment's effectiveness, ease of recovery, and the absence of serious side effects. In this study, trifecta is defined as relief from bothersome symptoms validated by international symptom score questionnaires, no urinary incontinence, and no serious events occurring within three months after HoLEP.

Conditions

HoLEP; Trifecta Achievement; Urinary Incontinence Following Surgical Procedure; Clavien Dindo Surgical Complication Scale; Lower Urinary Tract Symptoms (LUTS); Benign Prostatic Enlargement (BPE); Bladder Outlet Obstruction

Keywords

HoLEP Trifecta; HoLEP Symptomatic Relief; HoLEP Predictive Factors

Outcome Measures

Primary Outcomes (1)

• Trifecta achievement three months after HoLEP

  Achievement of all three of the following criteria, three months after HoLEP: 1. At least a 30% reduction in International Prostate Symptom Score (IPSS) 2. Absence of major complications (no Clavien-Dindo grade \> II), 3. No urinary incontinence

  From enrollment to the three months after the intervention for each participant.

Secondary Outcomes (2)

• Length of Hospital Stay After the Intervention

  Perioperative/Periprocedural

• Change in peak urinary flow rate (Qmax)

  Starting one month after the intervention and continuing for one year after the intervention, with multiple measurements.

Other Outcomes (2)

• Bladder Voiding Efficiency (BVE)

  From enrollment to the three months after the intervention.

• Enucleation-Volume Ratio

  Perioperative/Periprocedural

Study Arms (1)

HoLEP

EXPERIMENTAL

Only arm is the participants who are eligible to undergo HoLEP. Single arm, determination of predictors of the trifecta.

Procedure: Transurethral Holmium Laser Enuclation of the Prostate

Interventions

Transurethral Holmium Laser Enuclation of the Prostate PROCEDURE

HoLEP, En-bloc or tri-lobar technique.

HoLEP

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All male patients aged ≥ 40 years who are candidates for surgical treatment for BPO.
• Ability to provide informed consent, when required.

You may not qualify if:

• Clinically proven active condition(s) that require another intervention other than BPO surgery, such as lower urinary tract malignancy, urethral stricture, or neurogenic lower urinary tract symptoms.
• History of previous surgery for BPO, urethral stricture, or prostate cancer.
• Incomplete baseline or procedural data.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University, Samsun

Samsun, Turkey (Türkiye)

Location

Related Publications (3)

• Grosso AA, Amparore D, Di Maida F, de Cillis S, Cocci A, Di Dio M, Russo GI, Cimino S, Quara A, Salvi M, Fiori C, Mari A, Porpiglia F, Minervini A, Tuccio A. Comparison of perioperative and short-terms outcomes of en-bloc Holmium laser enucleation of the prostate (HoLEP) and robot-assisted simple prostatectomy: a propensity-score matching analysis. Prostate Cancer Prostatic Dis. 2024 Sep;27(3):478-484. doi: 10.1038/s41391-023-00743-6. Epub 2023 Oct 19.

  PMID: 37857831 BACKGROUND

• Bove AM, Brassetti A, Ochoa M, Anceschi U, D'Annunzio S, Ferriero M, Tuderti G, Misuraca L, Mastroianni R, Cartolano S, Torregiani G, Lombardo R, De Nunzio C, Simone G. Robotic simple prostatectomy vs HOLEP, a 'multi single-center' experiences comparison. Cent European J Urol. 2023;76(2):128-134. doi: 10.5173/ceju.2023.204. Epub 2023 Apr 17.

  PMID: 37483855 BACKGROUND

• Grosso AA, Di Maida F, Nardoni S, Salvi M, Giudici S, Lambertini L, Cadenar A, Tellini R, Cocci A, Mari A, Minervini A, Tuccio A. Patterns and Predictors of Optimal Surgical and Functional Outcomes after Holmium Laser Enucleation of the Prostate (HoLEP): Introducing the Concept of "Trifecta". World J Mens Health. 2023 Jul;41(3):603-611. doi: 10.5534/wjmh.220042. Epub 2023 Jan 1.

  PMID: 36593708 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases

Study Officials

• Murat Gulsen, MD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Gulsen Assistant Professor, MD

CONTACT

+905062357421; mglotr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Observational prognostic/predictive study.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 24, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): April 26, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)