Back to resultsEvaluation of Urine Leakage of New Absorbing Incontinence Products in a Home Care Environment
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SN2
SP3
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
- Surgery or hospitalization less than 4 weeks prior to study inclusion or planned surgery hospitalization during study conduct.
Sites / Locations
- Diakonissen-Stiftungs-Krankenhaus Speyer
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Other
Arm Label
SN2
SP3
TENA Proskin Pants Normal
TENA Pants Original Plus
Arm Description
new absorbing hygiene product with absorption level Normal.
new absorbing hygiene product with absorption level Plus.
Reference product currently used by the participant (control for SN2).
Reference product currently used by the participant (control for SP3).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of safety events
The number and severity of reported safety events are collected and compared for the intervention and reference products
Product Satisfaction questionnaire
To evaluate caregiver perception of and experience in using the products. Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Skin health questionnaire
To evaluate subject's skin health for the investigational product as compared to the reference product as part of the questionnaire
Full Information
NCT ID
NCT05484388
First Posted
June 15, 2022
Last Updated
February 20, 2023
Sponsor
Essity Hygiene and Health AB
Collaborators
Smerud Medical Research Germany Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05484388
Brief Title
Evaluation of Urine Leakage of New Absorbing Incontinence Products in a Home Care Environment
Official Title
A Randomized Crossover Study to Evaluate Urine Leakage of Pant Type Absorbing Incontinence Products of Two Absorption Levels in a Home Care Environment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
December 7, 2022 (Actual)
Study Completion Date
February 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Essity Hygiene and Health AB
Collaborators
Smerud Medical Research Germany Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The clinical investigation will be conducted to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity. The performance of the new design will be compared to that of the currently marketed TENA Pants, deemed state of the art.
To ensure that the personal preference of the study subjects are met, only current users of the marketed TENA pants will be recruited. To meet the objectives, the investigation is designed to be prospective, randomized, cross-over and interventional but not invasive with two different groups each testing one investigational-reference device pair matched to the currently used product at the time of inclusion. The study subjects will act as their own control, using one device for 10 (+ max. 3) days and then switching to the other device for additional 10 (+ max. 3) days. As for most users the avoidance of urinary leakages is the primary concern, this will be the primary outcome of the clinical investigation for each of the device pairs tested.
The used products will be collected, weighed and photographed. A subject/caregiver questionnaire will collect data on subject satisfaction and preferences. A skin health assessment will also be performed to evaluate any change in subject skin health before, during and at the end of the study.
Since the devices perform well in their intended use, leakage rate of each individual device is low, so a large number of devices needs to be tested per absorption level in order to obtain a robust assessment. Since the underlying incontinence condition is not affected by participation in the investigation, a sequential measurement series should be sufficient to meet the study objectives.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a prospective, randomized 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 as follows:
Prospective.
Randomized cross-over.
Interventional but non-invasive.
Decentralized in a home-care environment.
A pairwise comparative study.
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SN2
Arm Type
Experimental
Arm Description
new absorbing hygiene product with absorption level Normal.
Arm Title
SP3
Arm Type
Experimental
Arm Description
new absorbing hygiene product with absorption level Plus.
Arm Title
TENA Proskin Pants Normal
Arm Type
Other
Arm Description
Reference product currently used by the participant (control for SN2).
Arm Title
TENA Pants Original Plus
Arm Type
Other
Arm Description
Reference product currently used by the participant (control for SP3).
Intervention Type
Device
Intervention Name(s)
SN2
Intervention Description
Investigational device absorption level Normal
Intervention Type
Device
Intervention Name(s)
SP3
Intervention Description
Investigational device absorption level Plus
Primary Outcome Measure Information:
Title
Reported number of urinary leakages
Description
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
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Incidence of safety events
Description
The number and severity of reported safety events are collected and compared for the intervention and reference products
Time Frame
20 days
Title
Product Satisfaction questionnaire
Description
To evaluate caregiver perception of and experience in using the products. Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Time Frame
20 days
Title
Skin health questionnaire
Description
To evaluate subject's skin health for the investigational product as compared to the reference product as part of the questionnaire
Time Frame
20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Surgery or hospitalization less than 4 weeks prior to study inclusion or planned surgery hospitalization during study conduct.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kilian Pankert, MD
Organizational Affiliation
Diakonissen-Stiftungs-Krankenhaus Speyer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakonissen-Stiftungs-Krankenhaus Speyer
City
Speyer
ZIP/Postal Code
D- 67346
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Urine Leakage of New Absorbing Incontinence Products in a Home Care Environment
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