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

NCT06177821 | Recruiting

• 1 other identifier: REZUM
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Hyperplasia of the Medial Lobe

Keywords

median lobe enlargement; lower urinary tract symptoms; International Prostate Symptoms Score

Outcome Measures

Primary Outcomes (46)

• 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 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

  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

  1. 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 2. 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 3. 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

Study Arms (2)

Group A, 5 seconds

EXPERIMENTAL

Patients with benign prostatic hyperplasia featuring a small median lobe enlargement will be allocated to the 5-second Rezum therapy group.

Device: Rezum®

Group B, 9 seconds

EXPERIMENTAL

Patients with benign prostatic hyperplasia featuring a big prominent median lobe enlargement will be allocated to the 9-second Rezum therapy group.

Device: Rezum®

Interventions

Rezum® DEVICE

Rezum® Water vaporization device

Group A, 5 seconds; Group B, 9 seconds

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 20, 2023
• Study Start: June 3, 2024
• Primary Completion: June 17, 2024
• Study Completion: December 30, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)