MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Rate of Rezūm therapy failure
研究概览
简要总结
Rezūm is a minimally invasive procedure that uses water vapor (steam) to treat urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia, BPH). It has been used in clinical practice since receiving FDA approval in 2015 and is recommended as a treatment option for men with moderate-to-severe urinary symptoms, including those who wish to preserve ejaculatory function. Clinical trials have shown that Rezūm improves urinary symptoms and flow rates, with benefits that last for at least five years, a low reoperation rate, and a low risk of sexual side effects.
Despite this evidence, several important questions remain. It is not well understood which patients are more likely to experience temporary urinary retention after the procedure, need repeat treatment, or develop ejaculatory changes. Standardized criteria for defining overall treatment success are also lacking.
The MISTER study is a multicenter registry designed to evaluate real-world outcomes of Rezūm therapy in patients treated in the Russian Federation. Using data from a large patient cohort, the study aims to identify factors associated with urinary retention after catheter removal, the need for repeat treatment or return to medication, and changes in ejaculatory function. The study will also develop and test combined criteria for defining treatment success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Lower urinary tract symptoms (IPSS ≥8 points; QoL ≥3 points) due to BPH
- •Prostate volume of 30-150 cm³
- •Qmax ≤15 mL/s; post-void residual urine volume <300 mL
- •Non-Inclusion Criteria
- •Prostate cancer
- •Acute infections of the urinary tract, prostate, or scrotal organs
- •Neurogenic lower urinary tract dysfunction
- •Bladder stone(s)
- •Urethral stricture
- •Prior prostate surgery
排除标准
- •Patient refusal to allow use of medical data for scientific analysis
- •Missing or lost data required for analysis
结局指标
主要结局
Rate of Rezūm therapy failure
时间窗: 12 months
Rate of Rezūm therapy failure within 12 months after the intervention, defined as the occurrence of at least one of the following events: * Resumption or continuation of medical therapy for LUTS/BPH * Repeat surgical intervention for BPH * Failure to restore voiding
次要结局
- Post-void residual urine volume(14 days)
- International Prostate Symptom Score (IPSS)(3, 6, and 12 months)
- Qmax(3, 6, and 12 months)
- Prostate volume(3, 6, and 12 months)
- PSA level(3, 6, and 12 months)
- International Index of Erectile Function (IIEF-5)(3, 6, and 12 months)
- Rate of de novo retrograde ejaculation(3, 6, and 12 months)
研究者
Vladislav Petov
Assosiate Professor, urologist
Sechenov University