Rezum for 30-80ml Patients With Moderate-severe LUTS to Study Surgical Principles for Median Lobe Enlargement

Seoul National University Hospital44 enrolled

Overview

This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure configuration for the median lobe treatment being safer and standardizer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Hyperplasia of the Medial Lobe

Interventions

Rezum®DEVICE

Rezum® Water vaporization device

Eligibility

Sex: MALEMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 50 to 85 years who have been diagnosed with benign prostatic hyperplasia at Seoul National University Hospital and are scheduled to undergo endoscopic surgery. * benign prostatic hyperplasia ≥ 30 and \< 80 ml * Patients who have given written informed consent to participate in the study according to their age * A urinary symptom score (International ProstateSymptom Score \[IPSS\] moderated (8-19 points) to severe (20-35 points) * Measured Postvoiding Residual (PVR) \<250 mL Exclusion Criteria: * History of prostate or bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum * Active infection, treatment for chronic prostatitis * Diagnosis of urethral stricture, meatal stenosis or bladder neck contracture, damaged external urinary sphincter, stress urinary incontinence, post-void residual \>300 mL or urinary retention, or prior prostate surgery * Men taking anticoagulants or on bladder anticholinergics or with severe cardiovascular disease * PSA greater than 4.0 ng/ml (unless prostate cancer was ruled out by biopsy) * Allergy to device materials, immune suppressants or corticosteroids use, and serious medical or mental illness.

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

age

patient's records

Time frame: prior to procedure

Gender

patient's records

Time frame: prior to procedure

height

meters

Time frame: prior to procedure

weight

kilograms

Time frame: prior to procedure

Medical history

patient's records

Time frame: prior to procedure

Surgical history

patient's records

Time frame: prior to procedure

Date of consent

patient's records

Time frame: prior to procedure

Eastern Cooperative Oncology Group

0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead

Time frame: prior to procedure

complications

patient's records

Data from ClinicalTrials.gov

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Time frame: prior to procedure

medications used at the time of pre-consent

patient's records

Time frame: prior to procedure

drug allergies

patient's records

Time frame: prior to procedure

prostate specific antigen

patient's records, ng/ml

Time frame: prior to procedure, 3 month after surgery

Protein

Urinalysis, mg/dl