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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Prostatic Hyperplasia of the Medial Lobe

Intervention / Treatment
-----------------
* Device: Rezum®


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
median lobe enlargement, lower urinary tract symptoms, International Prostate Symptoms Score