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NCT Number: NCT07204002

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

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 70-80%.

There are various surgical procedures available for the treatment of BPH. In this study, we are investigating three surgical procedures which, based on the current data, appear to be relatively equivalent; however, additional data are still needed to substantiate this.

The aim of this study is to compare the three surgical methods REZUM vs. HoLEP vs. TUR-P for endoscopic transurethral subvesical de-obstruction with regard to both subjective and objective voiding function, as well as improvements in quality of life and sexual function.

The goal of the study is to work out the possible advantages and disadvantages for future patient counseling, thereby defining more precisely the role of these surgical procedures within the armamentarium of urology. This is a single-center, randomized, prospective interventional study.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Treatment BPH

Procedure

We compare 3 different types of BPH surgery - HoLEP vs. TURP vs. REZUM

Primary outcomes

  1. Non-inferiority of the surgical techniques in symptom improvement, determined by the change (delta) in the International Prostate Symptom Score (IPSS) at 1 month compared to baseline IPSS.

    Time frame: 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Conrad Leitsmann, PD Dr.

CONTACT

[email protected]

+43 316 385 81474

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Österreichische Gesellschaft für Urologie

Registry information

Acronym: Vektor

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Oct 2, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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