A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- The primary safety endpoint is the freedom from treatment-related adverse SAEs.
研究概览
简要总结
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
排除标准
- •Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
- •Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
- •Confirmed or suspected malignancy of prostate or bladder.
- •Active urinary tract infection (UTI)
- •Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
研究组 & 干预措施
Study Arm
This is the data collection study arm. There is no other arm in the study.
干预措施: Data collection (Other)
结局指标
主要结局
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
时间窗: Baseline to 12 months
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
The primary efficacy endpoint is the average IPSS change from baseline to 12 months.
时间窗: Baseline to 12 months
The primary efficacy endpoint is the average IPSS change from baseline to 12 months. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
次要结局
- Change in Qmax (mL per second) over time(From baseline to through study completion, an average of 2 years.)
- Frequency and severity of treatment-related AEs(From baseline to through study completion, an average of 2 years.)
- Freedom from repeat intervention (time-to-event)(From baseline to through study completion, an average of 2 years.)
- Change in IPSS over time(From baseline to through study completion, an average of 2 years.)
- Change in PVR over time(From baseline to through study completion, an average of 2 years.)