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Predictors of Trifecta Achievement After HoLEP

NCT07429994 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2026-02-24

No results posted yet for this study

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

Interventions

PROCEDURE

Transurethral Holmium Laser Enuclation of the Prostate

HoLEP, En-bloc or tri-lobar technique.

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Principal Investigators

  • Murat Gulsen, MD · Ondokuz Mayıs University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2028-04-26
Completion
2028-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429994 on ClinicalTrials.gov