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

NCT07204002 | Not Yet Recruiting Phase 4

• 1 other identifier: EK Nr: 1208/2024
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

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.

  1 month

Study Arms (3)

TURP

ACTIVE COMPARATOR

Procedure: Treatment BPH

HOLEP

ACTIVE COMPARATOR

Procedure: Treatment BPH

REZUM

ACTIVE COMPARATOR

Procedure: Treatment BPH

Interventions

Treatment BPH PROCEDURE

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

HOLEP; REZUM; TURP

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Österreichische Gesellschaft für Urologie: collaborator

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Conrad Leitsmann, PD Dr.

CONTACT

+43 316 385 81474; conrad.leitsmann@medunigraz.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2030
• Last Updated: November 19, 2025

Record last verified: 2025-09