Status:

NOT_YET_RECRUITING

Comparison of Convective Water Vapor Ablation (Convective Water Vapor Energy, WAVE™) With the Rezum™ System Versus Holmium Laser Enucleation of the Prostate (HoLEP) Versus Bipolar Transurethral Resection of the Prostate (TUR-P) in Patients With Benign Prostatic Syndrome (BPS) - A Randomized Study

Lead Sponsor:

Medical University of Graz

Collaborating Sponsors:

Österreichische Gesellschaft für Urologie

Conditions:

BPH (Benign Prostatic Hyperplasia)

HoLEP

Eligibility:

MALE

18+ years

Phase:

PHASE4

Brief Summary

Benign prostatic enlargement (BPH/BPS) is one of the most common benign diseases in adult men. About 50% of men are affected by the age of 50, and between the ages of 70 and 80 the prevalence rises to...

Eligibility Criteria

Inclusion

  • Age \> 18 years
  • Patients with confirmed benign prostatic syndrome for whom surgical therapy is indicated
  • Prostate volume between 30 and 80 ml

Exclusion

  • Lack of capacity to give informed consent
  • Emergency surgeries
  • Known prostate carcinoma
  • Elevated post-void residual urine \> 300 ml
  • Neurogenic bladder emptying disorder
  • Urethral pathologies
  • High-intensity anticoagulation
  • Dual antiplatelet therapy
  • History of pelvic radiation
  • Chronic pelvic pain syndrome

Key Trial Info

Start Date :

November 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 15 2030

Estimated Enrollment :

198 Patients enrolled

Trial Details

Trial ID

NCT07204002

Start Date

November 15 2025

End Date

October 15 2030

Last Update

November 19 2025

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