Status:
COMPLETED
A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product
Lead Sponsor:
Essity Hygiene and Health AB
Collaborating Sponsors:
Lincolnshire Community Health Services NHS Trust
Conditions:
Urinary Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 investi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06091111
Start Date
November 6 2023
End Date
June 30 2024
Last Update
September 19 2024
Active Locations (1)
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1
Lincolnshire Community Health Services NHS Trust
Lincoln, United Kingdom, LN5 7JH