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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Gender
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Gender
时间窗: prior to procedure
patient's records
height
时间窗: prior to procedure
meters
Surgical history
时间窗: prior to procedure
patient's records
Date of consent
时间窗: prior to procedure
patient's records
age
时间窗: prior to procedure
patient's records
Medical history
时间窗: prior to procedure
patient's records
weight
时间窗: prior to procedure
kilograms
medications used at the time of pre-consent
时间窗: prior to procedure
patient's records
drug allergies
时间窗: prior to procedure
patient's records
Protein
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, mg/dl
occult blood
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, Negative or positive
Eastern Cooperative Oncology Group
时间窗: prior to procedure
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
complications
时间窗: prior to procedure
patient's records
prostate specific antigen
时间窗: prior to procedure, 3 month after surgery
patient's records, ng/ml
creatinine
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dL
Hemoglobin
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, g/dl
pH
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis
Bacteria
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, Quantity
Chloride
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mEq/L
uric acid
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dl
Platelet
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, 10\^3/μL
Prostate specific antigen
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, ng/ml
Uroflowmetry
时间窗: prior to procedure, 3 month after surgery
patient's records, ml/sec
Brief Pain Inventory
时间窗: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Postvoiding Residual
时间窗: prior to procedure, 3 month after surgery
uroflowmetry
Post-surgery complications
时间窗: 1-2 weeks after injection, 3 month after surgery
patient's records
red blood cell
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, Quantity
Sodium
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mEq/L
McGill Pain Questionnaire
时间窗: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
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.
white blood cell : Urinalysis
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, Quantity
glucose
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Urinalysis, mg/dl
calcium
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dL
White blood cell : Blood tests
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, quantity
Prostate Ultrasound
时间窗: prior to procedure, 3 month after surgery
patient's records
International Index of Erectile Function
时间窗: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
The IIEF-5 Questionnaire (SHIM)Score for Erectile Dysfunction1-7: Severe8-11: Moderate12-16: Mild-moderate17-21: Mild22-25: No Erectile Dysfunction Survey.
transrectal sonography of the prostate
时间窗: prior to procedure, 3 month after surgery
Ultrasound examination
transrectal ultrasound
时间窗: prior to procedure
Ultrasound examination
Phosphorus
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dL
C-reactive protein
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dl
blood urea nitrogen
时间窗: prior to procedure, 1-2 weeks after injection, 3 month after surgery
Blood tests, mg/dl
International Prostate Symptom Score
时间窗: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Incontinence Severity Index
时间窗: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
Slight (1-2) Moderate (3-6) Severe (8-9) Very severe (12)
Male Sexual Health for assessing ejaculatory dysfunction
时间窗: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
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
Patient Global Impression of Improvement
时间窗: 1-2 weeks after injection, 3 month after surgery
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
Overactive Bladder Symptom Score
时间窗: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
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
Treatment Satisfaction-Visual Analogue Scale
时间窗: 1-2 weeks after injection, 3 month after surgery
0\. No, not at all satisfied. 10. Yes, completely satisfied.
次要结局
未报告次要终点
研究者
Sung Yong Cho
M.D., Ph.D.
Seoul National University Hospital
