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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2030-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TRP Versus Photo Selective Vaporization for Obstructive Benign Prostatic Hyperplasia Management

NCT01043588

Benign Prostatic Hyperplasia

COMPLETED NA

Middle Lobe Only Laser Vaporization or Total Prostate Vaporization of the Prostate, Prospective Cohort Study

NCT04529369

Benign Prostatic Hyperplasia

NOT_YET_RECRUITING NA

Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP

NCT04398420

Benign Prostatic Hypertrophy

TERMINATED NA

High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH

NCT03264482

Benign Prostatic Hyperplasia

COMPLETED NA

Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate

NCT06649357

Prostate Hyperplasia Surgery Endoscopic Anatomical Enucleation of the Prostate (EEAP)

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TURP

Group Type ACTIVE_COMPARATOR

Treatment BPH

Intervention Type PROCEDURE

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

HOLEP

Group Type ACTIVE_COMPARATOR

Treatment BPH

Intervention Type PROCEDURE

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

REZUM

Group Type ACTIVE_COMPARATOR

Treatment BPH

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Treatment BPH

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No