A Randomized Study of Pant Type Absorbing Urinary Incontinence Products With Cross-over Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Diary reported number of urinary leakages
研究概览
简要总结
Pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population
详细描述
The clinical clinical investigation is prospective, cross-over, interventional, multicentre and pre-market. The investigation aims to demonstrate the performance and safety of a new absorbing hygiene product (medical device) when used as intended in subjects affected with light to medium urinary incontinence compared to a reference (control) product representing standard of care.
The study participants will be randomly assigned to one of 4 groups. Each group will receive a predefined pair of investigational and reference products (variants: either high waist or low waist) to be used in a predefined order (crossover design: investigational or reference product to be used first). Hence, each study subject will use two products (one investigational product and a corresponding reference product of the same variant) and act as its own control. The study subjects will use one product for 5 days and then switch to use the other product for 5 days.
The primary endpoint for the investigation is the comparison in leakage performance of the investigation product with the reference product. There are also secondary endpoints regarding safety and product satisfaction and product preference.
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
- None
盲法说明
Participants are randomized to start with either reference or investigational product. The type of product is masked for the participant but since there are slight differences between the products the masking cannot be ensured.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women between age 45 and
- •Be willing and able to provide informed consent.
- •Capability and willingness to follow the protocol.
- •Experience incontinence daily or at least two times a week.
- •Uses some sort of protection for the incontinence daily or at least two times a week.
- •Uses five or more pieces of protection per week.
- •Is currently using protective underwear; a pull-up (pant) product made for incontinence.
- •Is able to wear a pant product of size M.
- •Is currently using TENA Silhouette or Always Discreet Boutique product.
- •Should be affiliate to the social security system.
排除标准
- •Is pregnant or nursing.
- •Known allergies or intolerances to one or several components of the investigational products.
- •Be dependent on either alcohol or recreational drugs.
- •Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation.
- •Being under safeguard and protection of justice
- •Having cognitive impairments.
- •Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
研究组 & 干预措施
low waist arm (investigational product RH1 first)
Investigational product RH1 (low waist) will be used for 5 consecutive days at the start before switching to the control product (low waist) for 5 days after cross-over.
干预措施: RH1 (low waist) (Device)
low waist arm (investigational product RH1 first)
Investigational product RH1 (low waist) will be used for 5 consecutive days at the start before switching to the control product (low waist) for 5 days after cross-over.
干预措施: Reference variant 1 (low waist) (Device)
high waist arm (Investigational product RC2 first)
Investigational product RC2 (high waist) to be used for 5 consecutive days at the start before switching to the control product (high waist) for 5 days after cross-over.
干预措施: RC2 (high waist) (Device)
high waist arm (Investigational product RC2 first)
Investigational product RC2 (high waist) to be used for 5 consecutive days at the start before switching to the control product (high waist) for 5 days after cross-over.
干预措施: Reference variant 2 (high waist) (Device)
low waist arm (Control product first)
Control product (low waist) to be used for 5 consecutive days at the start before switching to the investigational product RH1 for 5 days after cross-over.
干预措施: RH1 (low waist) (Device)
high waist (Control product first)
Control product (high waist) to be used for 5 consecutive days at the start before switching to the investigational product RC2 for 5 days after cross-over.
干预措施: RC2 (high waist) (Device)
low waist arm (Control product first)
Control product (low waist) to be used for 5 consecutive days at the start before switching to the investigational product RH1 for 5 days after cross-over.
干预措施: Reference variant 1 (low waist) (Device)
high waist (Control product first)
Control product (high waist) to be used for 5 consecutive days at the start before switching to the investigational product RC2 for 5 days after cross-over.
干预措施: Reference variant 2 (high waist) (Device)
结局指标
主要结局
Diary reported number of urinary leakages
时间窗: Through study completion until Day 12 +/-2
The proportion of products experiencing urine leakage over the 5 day test period is compared between the investigational and reference product. A diary is used to collect this information for each used product.
次要结局
- Product preference questionnaire(Measured on day 12 +/-2)
- Product satisfaction questionnaire(Day 12 +/-2)
- Incidence of safety events(Through study completion until Day 12 +/-2)
- Product satisfaction questionnaire(Day 6 +/-1)