N/A
Completed N=15
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
Source: ClinicalTrials.gov NCT04071301 ↗Enrolled (actual)
15
Serious AEs
13.3%
Results posted
Jun 2021
Primary outcomePrimary: Urine Volume Quantification and Impedance Measurements — 46 ml
Summary
This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Volume Quantification and Impedance Measurements |
46 | — |
Eligibility Criteria
Inclusion Criteria
- The subject is willing and able to provide informed consent and to participate in the clinical investigation.
- The subject is ≥18 years of age.
- The subject is diagnosed with urinary incontinence.
- The subject is being cared for at Tre Stiftelser.
Exclusion Criteria
- The subject has ≥ 4 fecal "incidences" per week.
- The subject has severe absorbent product related skin problems, as judged by the investigator.
- The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
- The subject has ≥ 2 intermittent urinary catheters per day.
- The subject has a pacemaker or an implantable cardioverter-defibrillator.
- The subject removes the incontinence product.
- The subject demonstrates responsive behavior towards sensors.
- The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
- The subject is not cared for at Tre Stiftelser.
- The subject is pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT04071301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.