The India Prostatic Tissue Lift Extend Observation Study: Prospective, observational, multicentre study to evaluate the outcomes in patients undergoing UroLift for lower urinary tract symptoms in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 145
- 试验地点
- 9
- 主要终点
- Mean change in IPSS score at 3 months from the baseline
研究概览
简要总结
This is a non-interventional, prospective, observational, multicentre study to evaluate the outcomes in patients undergoing UroLift procedure for lower urinary tract symptoms in India. The study aims to gain insights into outcomes of UroLift in clinical settings in India for treatment of patients with urinary outflow obstruction secondary to benign prostatic hyperplasia. The study also aims to enhance awareness about minimally invasive techniques like UroLift and address concerns surrounding BPH treatment’s impact on sexual function. The patients will be followed up for a period of 3 months. The primary objective is to estimate the mean change in International Prostate Symptom Score (IPSS) at 3 months from the baseline.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •1 Patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and undergoing UroLift procedure as determined by their urologist.
- •2 Males with age ≥ 50 years 3 International Prostate Symptom Score (IPSS) ≥ 13 4 Prostate volume ≤ 100 cc per imaging 5 Patients/LAR willing to sign written Informed Consent Form.
排除标准
- •1 Active urinary tract infection at time of treatment 2 Unable or unwilling to complete all required questionnaires and follow up assessments 3 Unable or unwilling to sign informed consent form.
结局指标
主要结局
Mean change in IPSS score at 3 months from the baseline
时间窗: 3 month
次要结局
- 1 Mean percentage change in IPSS score at 3 months from the baseline(2 Mean change in quality-of-life (QoL) due to urinary symptoms as measured by IPSS at 3 months from the baseline)
研究者
Dr Rohit Joshi
Aarna Super Speciality Hospital