Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Lahey Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To determine whether the design of the Uro-Ease Catheter device allows for easier, more comfortable clean intermittent self-catheterization (CIC) while maintaining safe bladder drainage. Using Visual Analog Scales and Timed procedure logs
研究概览
简要总结
To evaluate the ease of use and comfort of a new urinary catheter, the Uro-Ease, as used in the Clean Intermittent Catheterization (CIC)process.
详细描述
Urinary retention can occur among men with Benign Prostatic Hypertrophy(BPH) or Neurologic co-morbidities.
Many of these men are treated with Clean Intermittent Catheterization(CIC. For some, this can be a time consuming and often painful process due to difficulty with catheter insertion and manipulation, which may result in urethral injury or non-compliance.
The blunt nose of a standard catheter can meet significant resistance at the external sphincter or within the prostate urethra. Spirus Medical has developed a urinary catheter, Uro-Ease, with a rounded helical thread formed on the surface of its distal end for use in CIC.
This study is to determine whether the design of the Uro-Ease catheter allows for easier Clean Intermittent self-Catheterization(CIC) while maintaining safe bladder drainage.
This is a prospective randomized study with two phases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients
- •Urinary retention defined as >150cc retained in bladder on post void residual
排除标准
- •Female patients
- •Known urethral stricture
- •Active symptomatic Urinary Tract Infection
- •History of pelvic fracture or urethral disruption
- •History of previous urethroplasty(urethral reconstructive surgery)
- •Known Latex allergy
- •Unable to physically perform CIC
- •Unable to provide follow up
- •Unable to give consent
- •Currently taking chronic narcotic pain medication
结局指标
主要结局
To determine whether the design of the Uro-Ease Catheter device allows for easier, more comfortable clean intermittent self-catheterization (CIC) while maintaining safe bladder drainage. Using Visual Analog Scales and Timed procedure logs
时间窗: 2 weeks
次要结局
未报告次要终点