ProstaCare Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 6
- 主要终点
- Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the ProstaCare System in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •45 years of age or older with a diagnosis of BPH,
- •International Prostate Symptom Score (IPSS) of 12 or greater,
- •Prostate volume between 25 cm3 and 55 cm3,
- •Uroflow with peak flow rate (Qmax) no greater than 13 ml/sec with a corresponding voided volume of at least 100 ml and a post void residual (PVR) of 250 ml or less.
- •Prostate length, width and height must be at least 3.2 cm, 3.5 cm and 2.5 cm, respectively
排除标准
- •Obstruction due to an enlarged middle lobe, central gland or significant transverse asymmetry,
- •Subjects on 5 alpha reductase inhibitors (5-ARI) (inclusion only if washed out prior to treatment),
- •Subjects on alpha blockers (inclusion only if washed-out before treatment),
- •Active urinary tract infection at time of treatment,
- •Interest in maintaining fertility,
- •Past history of urologic surgery or minimally invasive treatment for BPH,
- •History of or current medical conditions contraindicating elective urological procedures.
结局指标
主要结局
Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit
时间窗: 3 months after treatment
The primary effectiveness objective was to demonstrate that mean IPSS improvement (Δ IPSS) following treatment with the prostaFix System exceeded 6.5 points with 95% confidence 3 months after treatment. The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess baseline and post treatment BPH symptoms. It is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the subject to choose one out of six answers indicating increasing severity of that particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic): Mild (symptom score less than or equal to 7), Moderate (symptom score range 8-19) and Severe (symptom score range 20-35). Improvement in BPH symptoms is seen as a decrease in IPSS.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: 3 months after treatment
The primary safety objective of this study was to estimate the proportion of subjects affected by serious adverse events (SAEs) associated with the use of the device. This objective was addressed through recording all adverse events (AEs) observed or reported during the course of the study.
次要结局
- Mean Change in QOL From Baseline(Baseline and 12 months from treatment)
- Mean Change in Post Void Residual (PVR) From Baseline(Baseline and 12 months from treatment)
- Mean Change in Peak Flow Rate (Qmax) From Baseline(Baseline and 12 months from treatment)
- Mean Change in MSHQ-EjD From Baseline(Baseline and 12 months from treatment)
- MRI Necrosis Volume(3 months after treatment)
- Change in IIEF Score From Baseline(Baseline and 3 months after treatment)
- Mean Change in IIEF From Baseline(Baseline and 12 months from treatment)
- Mean Change in MSHQ-EjD Score From Baseline(Baseline and 3 months after treatment)
- Mean Change in IPSS From Baseline(Baseline and 12 months from treatment)