18 and older, any sex, with Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Urine Volume Quantification and Impedance MeasurementsPrimary· 11 weeks
Descriptive statistics were used to summarize any individual differences between the predicted urine volume from the Change Indicator and the true urine volume (by measuring absorbent product weight). A measure of mean difference for the predicted volume minus true volume is assessed. A combination of these values were used to assess the mathematical algorithms for the TENA SmartCare Change Indicator.
Group
Value
95% CI
Investigational Device
46
± 213
Adverse events — posted to ClinicalTrials.gov
Time frame: 11 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT06092099 — Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.
· NA
· completed
NCT05247047 — The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities
· NA
· completed
NCT04846270 — Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Change
· NA
· completed
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Essity Hygiene and Health AB
Last refreshed: 2 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04071301.