Outcomes of Minimally Invasive Surgical Treatments (MIST) for Benign Prostatic Hyperplasia (BPH): A Single-Institution Prospective Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Symptom Scores
研究概览
简要总结
The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile.
详细描述
This prospective study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients who are to undergo Rezum or iTind procedure for BPH/LUTS between March 2024 and March 2025 are to be included in the study. Patient meeting inclusion criteria and exclusion criteria will be recruited to participate in this study.
Inclusion criteria: patients > 18 years of age, undergoing Rezum or iTind treatment Exclusion criteria: ASA III or higher, active UTI within past week, age < 18 years of age, no informed consent Follow-up/data measurements will occur pre-procedure, immediately post procedure, 1 week, 6 weeks, and 3 months following procedure. At time of consultation pre-procedure, baseline symptom scores, uroflow parameters will be obtained. VAS pain score is to be obtained during procedure, immediately post procedure, and at time of catheter or device removal 1 week post procedure. Uroflow parameters and symptoms scores will be again measured at 6 weeks and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •patients > 18 years of age undergoing Rezum or iTind treatment
排除标准
- •ASA 3 or higher, active UTI within past week, age < 18 years of age, no informed consent
结局指标
主要结局
Symptom Scores
时间窗: 1, 3, 6 months post-procedure
Using the IPSS (International Prostate Symptom Score) questionnaires to measure improvement in symptom scores
Uroflow
时间窗: 1, 3, 6 months post-procedure
Measuring uroflow parameters such as Qmax pre and post procedure
次要结局
- Pain Scale(1, 3, 6 months post-procedure)
研究者
Premal Patel, MD
Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education
University of Manitoba