Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
研究概览
简要总结
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. The aim of this study is to assess the feasibility of employing Catheterless Rezum post-operatively in patients with normal or strong bladder contractility. Upon a positive outcome of interim analysis, the effectiveness of Catheterless Rezum will be assessed at five sites for the multicenter phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Male subject of 40 - 80 years of age
- •Has provided informed consent
- •Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement
- •Able to complete self-administered questionnaires
- •Is a surgical candidate for Rezum
- •Has medical record documentation of Qmax < 15 ml/s
- •Has medical record documentation of prostate volume from 30-80 ml by transrectal ultrasound (TRUS)
- •Has a bladder contractility index score ≥ 100, calculated by detrusor pressure at Qmax (pDet@qmax) + (5xQmax).
- •Willing to undergo pressure-flow studies to calculate BCI prior to surgical intervention.
- •Has serum creatinine within the normal range.
- •Able to perform intermittent catheterization.
排除标准
- •Has a life expectancy < 2 years
- •Is currently enrolled in or plans to enroll in any concurrent drug or device study
- •Has an active infection (e.g., urinary tract infection or prostatitis)
- •Has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
- •Has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
- •Has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
- •Has a diagnosis of lichen sclerosis
- •Has a diagnosis of neurogenic bladder or other neurologic disorder that affects bladder function
- •Has a diagnosis of polyneuropathy (e.g., diabetic)
- •Has a history of lower urinary tract surgery
- •Has a diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
- •Has an inability to perform intermittent self-catheterization
- •Has been catheterized or has a post-void residual (PVR) of > 400 ml in the 14 days prior to the surgical procedure
- •Has a current diagnosis of bladder stones
结局指标
主要结局
Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
时间窗: Baseline, 36 months
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).
时间窗: Baseline, 36 months
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
次要结局
- Changes in urinary symptoms as measured by changes in IPSS.(Baseline, 36 months)
- Changes in urinary symptoms as measured by changes in Qmax at 36 months(Baseline, 36 months)