Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization - A Prospective, Blinded, Randomized, Cross-over, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 16
- 主要终点
- Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales
研究概览
简要总结
This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent.
- •Males, aged 18 years and over.
- •Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
- •Practice CIC at least 2 times daily.
- •Using catheters in the size CH 12 or CH 14, Nelaton tip, and able to use catheter length of 40 cm.
- •Experienced users of CIC defined as a minimum of three months on therapy.
- •Adults able to read, write and understand information given to them regarding the study.
排除标准
- •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 study (applies to both WHC staff and staff at the study site).
- •Previous enrolment or randomisation of treatment in the present study.
- •Simultaneous participation in another clinical study that may impact the primary endpoint.
- •Severe non-compliance to protocol as judged by the investigator
研究组 & 干预措施
Treatment Period One
LoFric, hydrophilic urinary catheter for single use. The study device is based on commercially available hydrophilic urinary catheters for intermittent catheterization, but with a different coating process than the comparator. Treatment Period One will last 1 week.
干预措施: Treatment Period One (Device)
Treatment Period Two
CE-marked LoFric®, hydrophilic urinary catheter for single use. The comparator product is today commercially available and produced by WHC. Treatment Period Two will last 1 week.
干预措施: Treatment Period Two (Device)
结局指标
主要结局
Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales
时间窗: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two
The primary objective of this study is to compare the subjects' tolerability of practising CIC by using two urinary catheters produced with different coating processes by means of subjective assessment scales.
次要结局
- Perception of the catheter's slipperiness, smoothness, flexibility, usability, and resistance, when practicing intermittent self-catheterization with urinary catheters; test vs. control catheter(2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period)
- Tolerability with regards to perceived pain, when using two different urinary catheters; test vs control catheter.(2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period)
- Tolerability with regards to presence of bleeding, when using two different urinary catheters; test vs control catheter(2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period)
- Tolerability with regards to perceived "other discomfort", when using two different urinary catheters; test vs. control catheter(2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period)
- To evaluate subject satisfaction with catheter; test vs. control catheter.(2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period)
- Total number of DD/AE/SAE/ADE/SADE/ USADE.(2 weeks in total.)