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 (Vektor)

Medical University of Graz

Status and phase: Not yet enrolling; Phase 4

Conditions: Rezum; TURP(Transurethral Resection of Prostate); HoLEP; BPH (Benign Prostatic Hyperplasia)

Treatments: Procedure: Treatment BPH

Study type: Interventional

Funder types: Other

Identifiers

NCT07204002

EK Nr: 1208/2024

Details and patient eligibility

About

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.

Enrollment: 198 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 3 patient groups

TURP

Active Comparator group

Treatment:

Procedure: Treatment BPH

HOLEP

Active Comparator group

Treatment:

Procedure: Treatment BPH

REZUM

Active Comparator group

Treatment:

Procedure: Treatment BPH