Continence Across Continents to Upend Stigma and Dependency (CACTUS-D)

Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence

Fonds de la Recherche en Santé du Québec, Medical Research Council, Canadian Institutes of Health Research (CIHR), Institut national de prevention et d'education pour la sante

To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.

This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on: Improved urinary symptoms and quality of life Reduction in falls Reduction in stigma A cost-effectiveness component will also be included

Urinary incontinence, Falls, Quality of life, Stigma, Community-dwelling older women, Continence promotion

A single 1-hour continence promotion group education workshop, facilitated by the research coordinator, aimed at changing knowledge and beliefs about urinary incontinence and different treatment options. An evidence-based self-management tool will be distributed at the end of the workshop.

A single 1-hour group education workshop on other health topics of concern to older women such as memory, hearing, insomnia

Cost/QALY. Direct costs will include costs related to the intervention as well as health care resource use due to incontinence-associated falls and health care seeking for incontinence will be measured. Indirect costs will be measured such as the time lost from work for a child or spouse to accompany the participant to receive medical treatment for incontinence or falls. The change in utility from the baseline incontinent condition to improved incontinence with increased social participation and decreased stigma on quality of life will be calculated from SF6D utilities derived from the SF-12 questionnaire at baseline and 1-year follow-up. A disease-specific measure, the IQOL is currently undergoing mapping onto the SF-6D to see if it will provide a more responsive indication of improved quality of life than the generic SF-12 measure.

Inclusion Criteria: Women 65 years and older Urinary incontinence at least once weekly Exclusion Criteria: Living in residential or long-term care Received treatment for incontinence within the past year Dementia or other neurological conditions that preclude the ability to provide -Informed consent

Agnew R, van den Heuvel E, Tannenbaum C. Efficiency of using community organisations as catalysts for recruitment to continence promotion trials. Clin Trials. 2013 Feb;10(1):151-9. doi: 10.1177/1740774512460144. Epub 2012 Oct 5.

Tannenbaum C, Agnew R, Benedetti A, Thomas D, van den Heuvel E. Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial. BMJ Open. 2013 Dec 10;3(12):e004135. doi: 10.1136/bmjopen-2013-004135.

Tannenbaum C, van den Heuvel E, Fritel X, Southall K, Jutai J, Rajabali S, Wagg A. Continence Across Continents To Upend Stigma and Dependency (CACTUS-D): study protocol for a cluster randomized controlled trial. Trials. 2015 Dec 10;16:565. doi: 10.1186/s13063-015-1099-x.