GreenLight XPS Laser System for the Treatment of Benign Prostatic Hyperplasia: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 956
- 试验地点
- 6
- 主要终点
- International Prostate Symptom Score (IPSS)
研究概览
简要总结
The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.
详细描述
This is a retrospective chart review conducted at six centers in the United States and Canada. This review will evaluate the safety and efficacy of GreenLight XPS in subjects who received treatment on or after 01-Aug-2010.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.
排除标准
- •Subject has had prior radiation.
- •Subject has a diagnosis of neurogenic bladder confirmed by urodynamic studies (BOO, detrusor overactivity (DO), impaired detrusor contractor (IDC))
- •Subject has a neurologic disorder that would impact bladder function (MS, Parkinson, Spinal Cord Injury) (note: Stroke patients not excluded)
- •Subject has an artificial urinary sphincter
结局指标
主要结局
International Prostate Symptom Score (IPSS)
时间窗: 6 months post-procedure
Evaluate the proportion of subjects who have mild or no BPH symptoms at six months post-procedure; e.g. an IPSS of eight or less at 6-month follow-up. An IPSS of eight or less indicates the subject is asymptomatic or has mild symptoms, a score of 9-21 indicates the subject has moderate symptoms, and a score of \>21 indicates the subject has severe symptoms. IPSS scores can range from 0-35.
Occurrence of Adverse Events Related to the Study Treatment.
时间窗: 365 Days
Treatment-related adverse events include: * Event related to the study device or procedure * Intra-operative adverse event related to the study device or procedure * Serious adverse events related to the study device or procedure The number of events as well as the number and percentage of subjects with the event will be calculated.
次要结局
- Type of Hospital Stay(Data will be collected during the time of their hospital stay from admission through discharge)
- Assess Changes in Objective Measures of Urologic Function.(From baseline through six months post-procedure.)
- Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence(90 days, 180 days)
- Length of Hospital Stay(The number of days from admission through discharge from the medical facility will be measured.)
- Number of Participants Stratified by Number of Fibers Used During Procedure(Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.)
- Changes in Objective Measures of Urologic Function(Baseline through six months post-procedure.)
- Assess Changes in Quality of Life Related to BPH Symptoms.(Baseline through six months post-procedure)
- Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure(Up to 90 days post-procedure.)
- Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients.(Procedure through five years post-procedure.)
- Assess Changes in Objective Measures of Urologic Function(Baseline through six months post-procedure)
- Characteristics of the Study Procedure(Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.)
- Characteristics of the Study Procedure and Immediate Outcomes(Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.)