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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorMedical University of Graz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Patients with confirmed benign prostatic syndrome for whom surgical therapy is indicated

Prostate volume between 30 and 80 ml

Disqualifiers

Emergency surgeries

Known prostate carcinoma

Elevated post-void residual urine > 300 ml

Neurogenic bladder emptying disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment BPH

    Procedure/Surgery

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

Treatment groups

198 Participants
are divided into 3 treatment groups
Group A: TURPActive comparator 1 intervention
Group B: HOLEPActive comparator 1 intervention
Group C: REZUMActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Graz

Lead sponsor

Österreichische Gesellschaft für Urologie

Collaborator

This trial is not recruiting at the moment. You can still explore other options: