At a glance
ClinicalIndex Comparison RecordN/ACompleted· 35 enrolled
Drug / intervention
TENA SmartCare Change Indicatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Single-arm, Post-market Clinical Investigation to Verify the Ability of TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products in a Home Environment.
In Brief
A clinical study evaluating TENA SmartCare Change Indicator for Urinary Incontinence. Completed, enrolled 35 participants across 1 site.
Detailed Summary
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence
CountriesPoland
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedApr 2021
Primary CompletionOct 2021
TodayJul 2026
First PostedApr 15, 2021
Enrollment StartApr 14, 2021
Primary CompletionOct 28, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.2 years ago
Interventions
TENA SmartCare Change Indicatordevice
Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.