Fact CheckerSign in

NCT07204002Not yet recruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 19 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
198 (estimated)
First submitted
24 Sept 2025
Start date
Nov 2025
Primary completion date
Oct 2026
Lead sponsor
Medical University of Graz
NCT number
NCT07204002

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 198
  • From Nov 2025 to the primary completion date, Oct 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Dual antiplatelet therapy

Other illness

  • Neurogenic bladder emptying disorder
  • History of pelvic radiation
  • Chronic pelvic pain syndrome

Other

  • Lack of capacity to give informed consent
  • Emergency surgeries
  • Known prostate carcinoma
  • Elevated post-void residual urine \> 300 ml
  • Urethral pathologies
  • High-intensity anticoagulation

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.