One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- q max
研究概览
简要总结
Objective: Rezūm vapor ablation is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezūm is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, it is unclear how effective Rezūm is for men in urinary retention. The investigators sought to determine whether Rezūm is effective in the treatment of catheter-dependent urinary retention secondary to BPH.
详细描述
The data of participants who underwent Rezūm operation with the diagnosis of BPH between 2021 and 2023 were evaluated retrospectively. The investigators evaluated procedure details and evaluated pre- and post-Rezūm (including International Prostate Symptom Score (IPSS), IPSS quality of life (IPSS-QOL), prostate volumes, maximum flow (Qmax), post-void residual urine volume, IEEF-5, ejaculation dysfunction). The investigators examined variables at 6 and 12 months).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Benign prostatic hyperplasia
排除标准
- •Prostate cancer
- •Parkinson's disease,
- •Neurogenic bladder
- •Overactive bladder
- •Bladder calculus,
- •Bladder Tumor
- •Urinary infection
- •Alzheimer's disease
结局指标
主要结局
q max
时间窗: 1 years
ml/sn
quality of life index
时间窗: 1 years
Scoring from 1-4, An increase in the quality of life means an increase in the score, or a decrease in the quality of life means a decrease in the score.
International Prostate Symptom Score,
时间窗: 1 years
Scoring from 1-35, An increase in symptoms means an increase in the score, or a decrease in symptoms means a low score.
次要结局
未报告次要终点
研究者
Basri Cakiroglu
Ass. Prof.
Hisar Intercontinental Hospital