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Starting soon Not applicable

Predictors of Trifecta Achievement After HoLEP

NCT07429994 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-30
Last updated
2026-02-24

Condition(s) studied

HoLEPTrifecta AchievementUrinary Incontinence Following Surgical ProcedureClavien Dindo Surgical Complication ScaleLower Urinary Tract Symptoms (LUTS)Benign Prostatic Enlargement (BPE)Bladder Outlet Obstruction

Investigational drug(s) / intervention(s)

Transurethral Holmium Laser Enuclation of the Prostate

Transurethral Holmium Laser Enuclation of the Prostate: HoLEP, En-bloc or tri-lobar technique.

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.

Eligibility

Sex
MALE
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * All male patients aged ≥ 40 years who are candidates for surgical treatment for BPO. * Ability to provide informed consent, when required. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Trifecta achievement three months after HoLEP — From enrollment to the three months after the intervention for each participant.
    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

Trial sites (1)

FacilityCityRegionStatus
Ondokuz Mayis University, Samsun Samsun Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07429994 on ClinicalTrials.gov ↗ ← All trials in Turkey