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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment BPH.
- Who it may be relevant to
- Registry conditions: BPH (Benign Prostatic Hyperplasia), HoLEP, Rezum, TURP(Transurethral Resection of Prostate). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Treatment BPH
We compare 3 different types of BPH surgery - HoLEP vs. TURP vs. REZUM
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07204002 · EK Nr: 1208/2024