A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in absorbing product leakage rate
研究概览
简要总结
The study is prospective, sequential, single group, and interventional but not invasive. The primary objective is to evaluate the leakage performance of the investigational medical devices (absorbing hygiene products, AHPs) compared to reference AHPs currently being used by the subjects. The study is cross-over and subjects will act as their own control, using their regular device during a 10-day period and comparing this to use of investigational device for 10 days with an initial 3-5 day transition period. In total the subjects participate in the study for about 30 days. The sequence of device use is randomized. The target population are subjects who are suffering from urinary incontinence and are current users of AHPs to manage the incontinence. Subjects are care dependent and being cared for in a care home. The study is conducted at multiple care homes in the United Kingdom. The investigational device is a new type of AHP developed to be more sustainable with a disposable insert placed into a reusable pant. The leakage performance will be tracked by collecting used AHPs and assess the occurrence of leakages and urine content. The number of leakages during the intervention period will be compared to that of the reference period. As secondary outcomes safety, changes in skin condition and caregiver and subject product satisfaction is assessed. In total 42 subjects are planned for the study.
详细描述
This is a pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population.
The clinical investigation is designed according to the ISO 14155:2020 to be prospective, interventional but non-invasive, at multiple care homes and randomised.
There is one group using two different reference products (TENA Comfort or TENA Slip) Cross-over with randomised sequential product use. Use of reference product (TENA comfort or TENA Slip) and investigational product (THD and THN) use.
Residents uses regular (reference) product for 10 days and then switch to the investigational product and use it for 10 days. There will be a 3-5-day transition period when the investigational product is introduced and then follows the 10-day evaluation period.
The investigational and the reference products for this study are absorbing hygiene products (class I medical devices) used as urine incontinence aids. Investigational devices (products) are new specifications THD and THN. THD and THN are hybrid products, consisting of a single use insert and a reusable pant, developed to be more sustainable than the current products in the market. Reference products are current all-in-one and/or two-piece product on the market TENA Slip/Comfort with super, plus and maxi absorption level and sizes M and L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
As the study device is obviously different to the currently used device, and all subjects will use the same treatment.
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
- •Have urinary incontinence managed with size M or L (96 -116 cm hip range) TENA Slip and/or TENA Comfort with absorption level plus, super or maxi.
- •Be willing and able to provide informed consent and to participate in the clinical investigation.
- •Be a permanent (intended length of stay longer than 3 months) resident of the care home.
- •Have a stable dose regime if the incontinence is managed by pharmaceuticals.
- •Be over 18 years of age.
- •Not be of child-bearing potential.
排除标准
- •Being cared for at home or outside of professional care environment.
- •Goes to the toilet to urinate regularly.
- •Have severe incontinence product related skin problems, as judged by the investigator.
- •Have any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- •Suffering from fecal incontinence with a severity that makes participation in the clinical investigation inappropriate, as judged by investigator.
- •Suffer from severe dementia that makes participation in the clinical investigation inappropriate, as judged by investigator.
- •Having any other condition or recent surgery that may make participation in the clinical investigation inappropriate, as judged by investigator.
- •Frequently removes the incontinence product by themselves.
- •Have participated in an investigational study of a drug, biologic, or medical device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
- •Having an alcohol or drug addiction.
研究组 & 干预措施
Intervention arm
Subjects is randomized to start with either a period of reference product use followed by a cross over to using the study device or the opposite sequence, starting with the study device and then cross over to using the reference device.
干预措施: THD, THN (Device)
结局指标
主要结局
Change in absorbing product leakage rate
时间窗: 20 days
For each resident a success rate (SR, number of products that do not have a urine leakage outside of the product) is calculated and compared between the baseline (standard of care) and the intervention (study device).
次要结局
- Safety data(20 days)
- Caregiver and resident scoring perception of the investigational product compared to the reference product.(20 days)
- Skin health assessment scoring.(20 days)