Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- change in prostate volume
研究概览
简要总结
This study aims to assess the effectiveness and morbidity of water vapor thermal therapy (Rezūm therapy) for benign prostatic hyperplasia (BPH). Data will be collected and analyzed from patients treated by Rezūm and followed up for 4 years prior to evaluating clinical outcomes.
详细描述
The investigators will conduct a retrospective study evaluating patients treated with water vapor thermal therapy (Rezūm therapy) for BPH and followed up for4 years. The primary objectives are to assess the long-term effectiveness and morbidity rates associated with the procedure. Data collected will include urinary symptom scores, sexual function, and any treatment-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years
排除标准
- •previous prostatic intervention
- •concurrent urological morbidity like urethral stricture
- •neurological disease like parkinson's disease
研究组 & 干预措施
patient treated by rezum procedure
patients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study
干预措施: water vapor thermal therapy (Rezum) for prostate (Procedure)
结局指标
主要结局
change in prostate volume
时间窗: 4 years
Prostate volume will be measured via transrectal ultrasound.
hange in International Prostate Symptom Score (IPSS)
时间窗: 4 years
IPSS is a questionnaire evaluating urinary symptoms. Scores ranging from 0 to 7 indicate mild symptoms, from 8 to 19 moderate symptoms, and from 20 to 35 severe symptoms.
international index of erectile function (IIEF)
时间窗: 4 years
IIEF is a questionnaire evaluating sexual function. Scores ranging from 5 to 7 indicate severe symptoms, 8 to 11 moderate symptoms, 12 to 16 mild to moderate symptoms, 17 to 21 mild symptoms, and 22 to 25 no erectile dysfunction
Change in Post-Void Residual Urine
时间窗: 4 years
Residual urine volume measured after urination using pelvic ultrasound.
次要结局
- Retreatment Rate Following Rezūm Therapy(4 years)
- complication rate(4 years)
研究者
Mahmoud Mohammed Elsaid Ali Elshahawy
Principal Investigator, Faculty of medicine
Helwan University