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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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07204002
Acronym
Vektor
Enrollment
198
Registered
2025-10-02
Start date
2025-11-15
Completion date
2030-10-15
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH (Benign Prostatic Hyperplasia), HoLEP, Rezum, TURP(Transurethral Resection of Prostate)

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 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.

Interventions

PROCEDURETreatment BPH

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

Sponsors

Österreichische Gesellschaft für Urologie
CollaboratorUNKNOWN
Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.1 month

Contacts

Primary ContactConrad Leitsmann, PD Dr.
conrad.leitsmann@medunigraz.at+43 316 385 81474

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026