A Multicenter, Double-blind, Crossover Design, Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 8
- 主要终点
- Catheter patency following treatment
研究概览
简要总结
NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others.
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs, and better patient quality of life.
The study population will include male and female spinal cord injury (SCI) and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation and/or blockage.
Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution. Each treatment regimen will consist of a total of 8 treatments, with a washout period between treatment regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation
- •Screening within 30 days of first treatment
排除标准
- •Systemic antibiotics within 7 days of first treatment
- •Investigational drug or device within 30 days of enrollment
- •Current infection that requires treatment with systemic antibiotics
- •Recent history of significant autonomic dysreflexia (requiring intervention or treatment)
研究组 & 干预措施
NVC-422
干预措施: NVC-422, 0.2% (Drug)
Saline
干预措施: Sterile normal saline, 0.9% (Drug)
结局指标
主要结局
Catheter patency following treatment
时间窗: 26 days
Cross sectional area (percent of open area that is not encrusted) will be determined at pre-selected loci on the catheter
次要结局
- Incidence of catheter blockage requiring early removal(26 days)
- Assessment of encrustation of catheter(26 days)
- Assessment of biofilm of catheter(26 days)