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

Feasibility of Water Vaporization (Rezum®) for Patients With ≥ 30 and < 80 ml With Moderate-severe LUTS to Establish the Surgical Principles for Prominent or Non-prominent Median Lobe Enlargement: A Single-center, Prospective, Pilot Study

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 Overview

• Status: Recruiting
• Conditions: Prostatic Hyperplasia of the Medial Lobe
• Intervention / Treatment: Device: Rezum®

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sung Yong Cho, M.D.,Ph.D.; Phone Number: +82-2-870-2394; Email: kmoretry@daum.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A, 5 seconds; Patients with benign prostatic hyperplasia featuring a small median lobe enlargement will be allocated to the 5-second Rezum therapy group.	Device: Rezum®; Rezum® Water vaporization device
Experimental: Group B, 9 seconds; Patients with benign prostatic hyperplasia featuring a big prominent median lobe enlargement will be allocated to the 9-second Rezum therapy group.	Device: Rezum®; Rezum® Water vaporization device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age	patient's records	prior to procedure
Gender	patient's records	prior to procedure
height	meters	prior to procedure
weight	kilograms	prior to procedure
Medical history	patient's records	prior to procedure
Surgical history	patient's records	prior to procedure
Date of consent	patient's records	prior to procedure
Eastern Cooperative Oncology Group	0 Fully active, able to carry on all pre-disease performance without restriction; 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; Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; Dead	prior to procedure
complications	patient's records	prior to procedure
medications used at the time of pre-consent	patient's records	prior to procedure
drug allergies	patient's records	prior to procedure
prostate specific antigen	patient's records, ng/ml	prior to procedure, 3 month after surgery
Protein	Urinalysis, mg/dl	prior to procedure, 1-2 weeks after injection, 3 month after surgery
pH	Urinalysis	prior to procedure, 1-2 weeks after injection, 3 month after surgery
occult blood	Urinalysis, Negative or positive	prior to procedure, 1-2 weeks after injection, 3 month after surgery
white blood cell : Urinalysis	Urinalysis, Quantity	prior to procedure, 1-2 weeks after injection, 3 month after surgery
glucose	Urinalysis, mg/dl	prior to procedure, 1-2 weeks after injection, 3 month after surgery
red blood cell	Urinalysis, Quantity	prior to procedure, 1-2 weeks after injection, 3 month after surgery
Bacteria	Urinalysis, Quantity	prior to procedure, 1-2 weeks after injection, 3 month after surgery
Sodium	Blood tests, mEq/L	prior to procedure, 1-2 weeks after injection, 3 month after surgery
Chloride	Blood tests, mEq/L	prior to procedure, 1-2 weeks after injection, 3 month after surgery
calcium	Blood tests, mg/dL	prior to procedure, 1-2 weeks after injection, 3 month after surgery
Phosphorus	Blood tests, mg/dL	prior to procedure, 1-2 weeks after injection, 3 month after surgery
uric acid	Blood tests, mg/dl	prior to procedure, 1-2 weeks after injection, 3 month after surgery
blood urea nitrogen	Blood tests, mg/dl	prior to procedure, 1-2 weeks after injection, 3 month after surgery
creatinine	Blood tests, mg/dL	prior to procedure, 1-2 weeks after injection, 3 month after surgery
C-reactive protein	Blood tests, mg/dl	prior to procedure, 1-2 weeks after injection, 3 month after surgery
White blood cell : Blood tests	Blood tests, quantity	prior to procedure, 1-2 weeks after injection, 3 month after surgery
Hemoglobin	Blood tests, g/dl	prior to procedure, 1-2 weeks after injection, 3 month after surgery
Platelet	Blood tests, 10^3/μL	prior to procedure, 1-2 weeks after injection, 3 month after surgery
Prostate specific antigen	Blood tests, ng/ml	prior to procedure, 1-2 weeks after injection, 3 month after surgery
Prostate Ultrasound	patient's records	prior to procedure, 3 month after surgery
Uroflowmetry	patient's records, ml/sec	prior to procedure, 3 month after surgery
International Prostate Symptom Score	0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms	prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Incontinence Severity Index	Slight (1-2) Moderate (3-6) Severe (8-9) Very severe (12)	prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Overactive Bladder Symptom Score	1. How many times do you typically urinate from waking in the morning until sleeping at night? 7 or less 8 to 14 15 or more 2. How many times do you typically wake up to urinate from sleeping at night until waking in the morning? 0 1 2 3 or more 3. How often do you have a sudden desire to urinate, which is difficult to defer? Not at All less than once a week once a week or more about once a day 2 to 4 times per day 5 times a day or more 4. How often do you leak urine, because you cannot defer the sudden desire to urinate? Not at All less than once a week once a week or more about once a day 2 to 4 times per day 5 times a day or more	prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Male Sexual Health for assessing ejaculatory dysfunction	In the last month, without using drugs like Viagra, how often have you been able to get an erection when you wanted to? 5 All of the time 4 Most of the time 3 About half of the time 2 Less than half of the time 1 None of the time 0 Used Viagra or similar drug with every sexual encounter; In the last month, if you were able to get an erection without using drugs like Viagra, how often were you able to stay hard as long as you wanted to? 5 All of the time 4 Most of the time 3 About half of the time 2 Less than half of the time 1 None of the time 0 Used Viagra or similar drug with every sexual encounter; In the last month, if you were able to get an erection, without using drugs like Viagra, how would you rate the hardness of your erection? 5 Completely hard 4 Almost completely hard 3 Mostly hard, but can be slightly bent 2 A little hard, but bends easily 1 Not at all hard 0 Used Viagra or similar drug with every sexual encounter	prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
International Index of Erectile Function	The IIEF-5 Questionnaire (SHIM)Score for Erectile Dysfunction1-7: Severe8-11: Moderate12-16: Mild-moderate17-21: Mild22-25: No Erectile Dysfunction Survey.	prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
McGill Pain Questionnaire	The interpretation of the questionnaire is pretty basic: the higher the score, the higher the pain level. The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain.	prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Brief Pain Inventory	Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.	prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Treatment Satisfaction-Visual Analogue Scale	0. No, not at all satisfied. 10. Yes, completely satisfied.	1-2 weeks after injection, 3 month after surgery
Patient Global Impression of Improvement	Very much better 1 Much better 2 A little better 3 No change 4 A little worse 5 Much worse 6 Very much worse 7	1-2 weeks after injection, 3 month after surgery
transrectal sonography of the prostate	Ultrasound examination	prior to procedure, 3 month after surgery
transrectal ultrasound	Ultrasound examination	prior to procedure
Postvoiding Residual	uroflowmetry	prior to procedure, 3 month after surgery
Post-surgery complications	patient's records	1-2 weeks after injection, 3 month after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 3, 2024
• Primary Completion (Estimated): June 17, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lower urinary tract symptoms; median lobe enlargement; International Prostate Symptoms Score
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Pathological Conditions, Anatomical; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Hypertrophy
• Other Study ID Numbers: REZUM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets used during the current study are available from the corresponding author on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No