Evaluation of Urine Leakage of New Absorbing Incontinence Products in a Home Care Environment
A Randomized Crossover Study to Evaluate Urine Leakage of Pant Type Absorbing Incontinence Products of Two Absorption Levels in a Home Care Environment
1 other identifier
interventional
84
1 country
1
Brief Summary
The aim of this interventional but non-invasive, clinical investigation is to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity. The primary objective is to demonstrate for each of the new products that they provide protection to leakages similar to their corresponding standard of care devices already used on the market. The target population for this clinical investigation are community living individuals suffering from moderate to severe incontinence, who may receive care by a care giving relative, by one or more caregivers and are current users of TENA Pants of the respective absorption level.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 2, 2022
CompletedStudy Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2023
CompletedFebruary 21, 2023
February 1, 2023
2 months
June 15, 2022
February 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Reported number of urinary leakages
The proportion of products experiencing urine leakage over the 10 day test period is compared between the investigational and reference product. Labels are used to collect this information for each used product
20 days
Secondary Outcomes (3)
Incidence of safety events
20 days
Product Satisfaction questionnaire
20 days
Skin health questionnaire
20 days
Study Arms (4)
SN2
EXPERIMENTALnew absorbing hygiene product with absorption level Normal.
SP3
EXPERIMENTALnew absorbing hygiene product with absorption level Plus.
TENA Proskin Pants Normal
OTHERReference product currently used by the participant (control for SN2).
TENA Pants Original Plus
OTHERReference product currently used by the participant (control for SP3).
Interventions
Eligibility Criteria
You may qualify if:
- criteria to be eligible for this clinical investigation:
- Subject is diagnosed with moderate to severe urinary incontinence managed only with TENA Pants absorbent hygiene products of size Medium or Large with the same absorption level that is used in the study since at least 4 weeks.
- Subject is living at home and should have a care giving relative supported by a professional caregiver giver to manage daily activities and incontinence related tasks.
- Subject is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the subject.
- Care giving relative is willing and able to provide informed consent to participate in the clinical investigation.
- If incontinence is managed by pharmaceuticals, the dose regime is stable.
- Subject and care giving relative (if any) are over 18 years of age.
- Post-menopausal women or no longer of child-bearing potential
You may not qualify if:
- Subject is cared for in a professional establishment or is institutionalized.
- Subject has severe incontinence product related skin problems corresponding to scores equal to or higher than 4 in the skin health assessment, as judged by the investigator.
- Subject suffers from regular faecal incontinence more than once a week.
- Subject has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
- Subject or care giving relative is incapable or unwilling to collect used products and fill out the bag label required for the clinical investigation.
- Participation in another investigational study of a drug, biologic, or medical device within 30 days prior to entering the clinical investigation or planned during the clinical investigation as well as prior participation in this investigation
- Subject is pregnant or nursing or of childbearing potential.
- Investigator suspects that subject or care giving relative has an alcohol or drug addiction.
- Subject and/or caregiving relative is closely affiliated with or in hierarchical dependency of the Sponsor, PI, or CRO involved in this study
- Subject's incontinence is currently managed by more than 1 type of AHP's
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Essity Hygiene and Health ABlead
- Smerud Medical Research Germany Ltdcollaborator
Study Sites (1)
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, D- 67346, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kilian Pankert, MD
Diakonissen-Stiftungs-Krankenhaus Speyer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2022
First Posted
August 2, 2022
Study Start
October 3, 2022
Primary Completion
December 7, 2022
Study Completion
February 3, 2023
Last Updated
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share