Trial reportTrials2023
A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents.
Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05247047 (A Post-market Cluster Randomized Controlled Trial of the Effect of the TENA SmartCare Change Indicator on Continence Care Efficiency and Skin Health in Long Term Care Facilities), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Post-market Cluster Randomized Controlled Trial of the Effect of the TENA SmartCare Change Indicator on Continence Care Efficiency and Skin Health in Long Term Care Facilities
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Skin cleansers and leave-on product interventions for preventing incontinence-associated dermatitis in adults.The Cochrane database of systematic reviews · 2025Pooled it
- A post-market, cluster randomised controlled trial of the effect of the TENA SmartCare Change Indicator on continence care efficiency and skin health in nursing homes.Age and ageing · 2025Trial
- Review
- Urinary and Double Incontinence in Cognitively Impaired Patients: Impacts on Those Affected and Their Professional Caregivers.Journal of clinical medicine · 2023Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUrinary continence care for residents of nursing homes who are unable to communicate their toileting needs usually involves care aides manually checking continence products (pads) to determine the level of urine saturation prior to changing. The TENA SmartCare Change Indicator is a medical device which estimates urine saturation and notifies caregivers of the optimal time for pad changes. This study will seek to examine the effect of the TENA SmartCare Change Indicator on urinary continence care efficiency and skin health, in comparison to usual care.
methodsThis cluster randomized controlled trial (NCT05247047) involving older nursing home residents with urinary incontinence unable to consistently indicate their toileting needs, and their care aides, will compare technology-based and usual continence care over a period of 8 weeks. Co-primary endpoints of superiority in continence care efficiency and non-inferiority in the maintenance of skin health will be assessed. Secondary outcomes will examine the resident quality of life, sleep quality, responsive behaviours, changes in pad use and leakage episodes outside the pad. Change in care aide work engagement, job satisfaction and rushed tasks will be assessed. Benefits and challenges with the use of the device for continence care will be identified from the perspectives of the care staff. DISCUSSION: Urinary continence assessment and care in nursing homes is reported as suboptimal and threatening to dignity. Data on the utility and effect of technological solutions for improving urinary continence care are few and conflicting. If shown effective, this technological solution has the potential to improve the care for older residents and improve the working lives of caregiving staff who look after this most vulnerable section of the population.
trial registrationClinicalTrials.gov NCT05247047. Registration date is Feb 18, 2022.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.