NCT02129738已完成不适用
Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 7
- 主要终点
- Proportion of catheters with bacterial contamination (Y/N)
研究概览
简要总结
The purpose of this study is to investigate and document real life safety and satisfaction of re-use of urethral catheters for intermittent self catheterization. The study will collect re-used catheters from included patients and compare those to a control group with regard to bacterial contamination and mechanical properties. A four week prospective evaluation will follow where the patients will be given catheters intended for single-use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Provision of informed consent
- •Female and/or male aged 18 years and over
- •Intermittent self-catheterization as primary bladder management method, defined as a normal catheterization frequency of at least 4 times daily
- •Reuse of the same silicon, rubber (latex) or plastic (e.g. vinyl, PVC) catheter
- •Accustomed intermittent catheterization user, defined as intermittent catheterization use for at least 3 months
- •Able to use catheters of size:
- •40 cm, CH12 or CH14; 16'', FR12 or FR14; 15 cm, CH10 or CH12; 6'', FR10 or FR12;
排除标准
- •Antibiotic treatment within 4 weeks prior study inclusion
- •Drug or alcohol abuse or other disease of addiction
- •Immunocompromising diseases or medications
- •Known urological/renal anatomical abnormalities with potential impact on subject´s compliance as judged by the investigator
- •Diagnosis of severe fecal incontinence that may compromise study participation as judged by the investigator
- •Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
- •Previous enrollment in the present study
- •Simultaneous participation in another clinical study that may interfere with the present study, as judged by the investigator
- •Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
研究组 & 干预措施
LoFric
Experimental
LoFric catheters
干预措施: LoFric catheters (Device)
结局指标
主要结局
Proportion of catheters with bacterial contamination (Y/N)
时间窗: At Baseline (Visit 1)
Proportion of catheters with bacterial contamination verified by culturing/incubation and visual inspection by Scanning Electron Microscope (SEM).
次要结局
- Bacterial quantification by incubation.(At Baseline (Visit 1))
- Pathogen identification by incubation.(At Baseline (Visit 1))
- Material properties and bacteria/particle/tissue visualization by SEM.(At Baseline (Visit 1))
- Presence of reuse found in medical records, patient reported questionnaires and patient interviews.(At Baseline (Visit 1) and at 4 weeks (Visit 2))
- Bacterial level in urine sample(At Baseline and 4 weeks)
研究者
研究点 (7)
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