NCT04703413终止不适用
User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.
研究概览
简要总结
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
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
- •For inclusion in the study, subjects must fulfil all of the following criteria:
- •Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form
- •Aged 18 years and over, both gender
- •Bladder dysfunction, all diagnosis practicing IC at least 2 times daily
- •Using catheters in the sizes available in the investigation (15 cm, CH 12 or 40 cm CH 12/14, Nelaton tip)
- •Experienced users of IC defined as a minimum of 4 weeks on therapy prior investigation start
- •Adults able to read, write and understand information given to them regarding the investigation
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study:
- •Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
- •Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
- •Involvement in the planning and conduct of the investigation (applies to both Wellspect/site staff).
- •Previous enrolment in the present investigation.
- •Simultaneous participation in another clinical investigation that may impact the primary endpoint.
- •Expected or severe non-compliance to the CIP as judged by the investigator and/or Wellspect.
结局指标
主要结局
Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.
时间窗: 30 days
The subject's assessment of satisfaction using a five-level scale in a pPRO (Wellspect Follow-up questionnaire): How satisfied have you been with the catheterization (insertion/withdrawal) when using the investigational device? 1. = completely unsatisfied 2. = unsatisfied 3. = neutral 4. = satisfied 5. = completely satisfied
次要结局
- Reason for dissatisfaction (if any) when practicing IC with study device.(30 days)
- Catheter usability (incl. ease of use) when practicing IC with investigational device.(30 days)
- QoL when practicing IC with investigational device.(30 days)
- Experience of any problems before, during and after catheterization with investigational device.(30 days)
研究者
研究点 (6)
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