Leakage performance of Hybrid incontinence product
Research type
Research Study
Full title
A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product
IRAS ID
327359
Contact name
Janice Wiseman
Contact email
Sponsor organisation
Essity / BSN medical GmbH
ISRCTN Number
ISRCTN46745645
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
000000000000000, 000000000000
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
Summary of Research: This clinical investigation is designed to evaluate the clinical performance and safety of a new absorbing hygiene product medical device when used as intended in subjects affected with urinary/ faeces incontinence compared to a reference device representing standard of care in a care home setting. All residents will use their regular device for a 10-day baseline period followed by 13-15 days of investigational device use and the actual and perceived performance of the devices will be compared.
Summary of Results: Participant flow: Enrolled/Randomized: 44 subjects
Discontinued: 13 subjects
Completed: 31 subjectsAll participants were supposed to use both the reference and the investigational products during two successive time periods of 10 days each, connected by a transition period of 3-5 days.
Baseline demographic and clinical characteristics:
Subjects were male and female care home residents with an average age of 85 years. They had varying levels of care need and were suffering from regular urinary incontinence mitigated by using TENA Comfort or TENA Slip absorbing incontinence products.Care providers were trained for the study procedures by the PI, as far as this was possible, on an ongoing basis.
Outcome of the intervention:
The study aimed to investigate the leakage performance and safety of the investigational products (THD and THN) compared to current standard of care reference products. 31 residents contributed data for the primary outcome, 19 who were solely using TENA Comfort reference products, 10 who were solely using TENA Slip reference products and 2 subjects who were using both reference products. The primary outcome measure was the success rate (SR), defined as % of urine leakage (yes or no for each product) whereby no leakage was considered as success under treatment. About 1400 used products were evaluated for the primary outcome almost evenly split between investigational and reference products. In total around 300 urine leakages were recorded. SR for the reference products was 73%. SR for the investigational products was 78%. In the TENA Comfort subgroup, the SR was 67% and for TENA Slip subgroup, it was 84%. In the same subgroups the corresponding SR for the investigational product was 77% and 81%. The mean difference in SR between investigational and reference product is 5% and between investigational and TENA Comfort products 10%, and between study and TENA Slip products -3 %. The non-inferiority test for the pairwise difference was significant for the combined data set meaning that non-inferiority can be rejected. When looking at the subgroups for TENA Comfort and TENA Slip the non-inferiority test was significant for the TENA Comfort group but not for the TENA Slip group. This means that for TENA Comfort we can reject non-inferiority of the SR but not in the Slip group. Hence, we cannot conclude that the investigational product does not have an inferior SR compared to TENA Slip products. However, for the TENA Comfort group we saw a significant superiority test meaning that the investigational product appears superior to the TENA Comfort products regarding SR.A secondary outcome in the study was caregiver and resident satisfaction. Overall, the satisfaction of both reference and investigational products are high and there are no significant differences. However, several other aspects of the investigational product demonstrated a significantly better satisfaction score among caregivers and residents than the reference products.
Another secondary outcome was caregiver and resident agreement to statements about the investigational product. Most caregivers agreed with the statements regarding the investigational product. The resident thought the investigational product more comfortable than the reference product with a 2:1 ratio. Furthermore, 9 out of 10 caregivers would consider changing to the investigational product. A majority of residents would also consider changing to the investigational product.
A secondary outcome was caregiver and resident preference towards the investigational product versus the reference products.Caregivers significantly preferred the investigational product. Residents were more divided in their preference and there was no significant preference choice. However, when looking at the detailed preferences, caregivers and residents prefer the investigational product in many aspects.
The last secondary outcome was the skin health assessment. At the end of the study 3 residents showed mild irritation compared to 25 residents that showed no sign of skin irritation. The irritation was described as persistent redness and was mostly confined to back of the thigh. Overall, the changes in skin condition of the residents during the investigation were minor.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0284
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion