NCT02643849已完成不适用
Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments
SRS Medical12 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2016年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 12
- 主要终点
- Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days
研究概览
简要总结
The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.
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
- •Age > 45 years;
- •In urinary retention and catheterized (indwelling or intermittent) for less than 180 days;
- •Documented diagnostic history (within 180 days of study) of detrusor contractility (>= 15 cmH2O) confirmed via pressure-flow test;
- •Negative Urinalysis on Visit 1;
- •Not a candidate for pharmacologic, minimally invasive or surgical treatment of the prostate;
- •Charlson Weighted Index of Comorbidity Score >= 1;
- •Willing and able to sign the Informed Consent Form;
- •Willing and able to complete the follow-up protocol requirements;
- •Experiencing catheter-induced discomfort.
排除标准
- •Current use of a urinary catheter daily for greater than 180 consecutive days immediately preceding entering into the study;
- •Positive Urinalysis on Visit 1;
- •Current or recent (within the last 6 months) urinary tract disease including urethral stricture, bladder stones, and other significant urological conditions or surgery;
- •Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affect the function of the lower urinary tract;
- •History of conditions associated with neurogenic bladder, including spinal cord injury, multiple sclerosis, or Parkinson's disease;
- •Use of anticholinergic medication;
- •Gross hematuria when catheter is removed on Visit 1;
- •Known or suspected prostate cancer;
- •Prior pelvic irradiation therapy;
- •Prostatic urethral length < 4 cm or > 9 cm (combined length from the top proximal side of the bladder neck to the bottom distal side of the external sphincter);
- •Intravesical enlargement of the median lobe of the prostate.
结局指标
主要结局
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days
时间窗: 90 days
To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.
次要结局
- Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days(30 days)
研究者
研究点 (12)
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