User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 3
- 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.
研究组 & 干预措施
LoFric® OrigoTM or LoFric® SenseTM
Hydrophilic male (LoFric Origo) and female (LoFric Sense) urinary catheters for single use. Target subject population are subjects suffering from bladder voiding dysfunction and are experienced in intermittent catheterization (IC).
干预措施: LoFric® OrigoTM and LoFric® SenseTM (Device)
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)