A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Preference of the Two Urostomy Products
研究概览
简要总结
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
详细描述
The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Be at least 18 years old,
- •Be able to complete a written consent form
- •Be able to fill in the Case Report Form
- •Have a urostomy with a diameter of 33 mm. or less.
- •Have had the urostomy for 3 months or more.
- •Use a 2-piece convex (or convex light) normally.
- •Be able to use SenSura URO 2-piece product
- •Be able to use ConvaTec, 2-piece product
- •Be able to handle the product themselves (application, removal and emptying),
排除标准
- •In order to be enrolled in the clinical investigation, the subjects must not:
- •Need to use an ostomy belt
- •Be currently suffering from any dermatological problems, needing special treatment, on the peristomal skin
- •Being treated with chemo- or radiation therapy,
- •Be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or
- •Be pregnant or breast-feeding.
研究组 & 干预措施
SenSura
SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
干预措施: SenSura Uro 2-piece (Device)
Convatec
Convatec Uro 2-piece Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
干预措施: Convatec Uro 2-piece (Device)
结局指标
主要结局
Preference of the Two Urostomy Products
时间窗: 6 weeks
Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product. The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.
次要结局
未报告次要终点