A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product

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.

Primary objective: To evaluate the leakage performance of the investigational products compared to reference products.

Secondary objective(s):

To evaluate safety through analysing product-related adverse events reported during the investigation.

To evaluate any changes in skin condition of the resident during the course of the investigation.

To evaluate caregiver and subject, satisfaction, perception of and experience in using the products related to comfort, softness, dryness, skin health and ease of product washing.

In the study, the products are used by individuals, residents, suffering from incontinence who are cared for in a care home, by one or more professional caregivers.

Multiple care homes within Lincolnshire in the United Kingdom. Lincolnshire Community Health Services National Health Services Trust acts as site and coordinates the care homes. Care homes will be randomised to either start with reference product or investigational product.

A total of 42 subjects is to be included.

For the residents there will be 5 visits:

Visit 1 Screening and recruitment. Visit 2 Period 1 start (Day 0). Visit 3 Transition period start (Day 10+3). Visit 4 Start of period 2 (3-5 days after visit 3). Visit 5 Study completion (Day 10+3 after visit 4).

Between visit 2 and 5 there will be a daily collection by the study team of labelled bags containing used products. These products will then be weighed, labels retrieved, and photos taken.

A descriptive analysis will be carried out for all variables and endpoints. For the analysis each tested product is classified according to presence of leakage (Yes/No). The proportion of products that do not leak is designated the success rate (SR). A non-inferiority one-sided paired t-test will be performed to analyse the primary endpoint.

For the safety endpoint, data on incidence and severity of adverse events related to products will be summarized.

The error rate is set to 2.5% for the primary endpoint and 5% for secondary endpoints.

Inclusion criteria

• 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.

Exclusion criteria

• 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.