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临床试验/NCT06177821
NCT06177821招募中不适用

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

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 44 人开始时间: 2024年6月3日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung Yong Cho

M.D., Ph.D.

Seoul National University Hospital

研究点 (2)

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