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Continence Across Continents to Upend Stigma and Dependency

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01858493
Acronym
CACTUS-D
Enrollment
910
Registered
2013-05-21
Start date
2013-05-31
Completion date
2017-07-31
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falls, Accidental, Quality of Life, Stigma, Urinary Incontinence

Keywords

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

Brief summary

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.

Detailed description

This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on: 1. Improved urinary symptoms and quality of life 2. Reduction in falls 3. Reduction in stigma A cost-effectiveness component will also be included

Interventions

BEHAVIORALContinence promotion group education workshop

Interactive group education workshop promoting continence

BEHAVIORALSham health lecture

Interactive group education workshop about general health

Sponsors

Fonds de la Recherche en Santé du Québec
CollaboratorOTHER_GOV
Medical Research Council
CollaboratorOTHER_GOV
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Institut national de prevention et d'education pour la sante
CollaboratorOTHER_GOV
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported improvement in urinary incontinence1 yearPatient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS

Secondary

MeasureTime frameDescription
Falls1 yearReduction in incontinence-related falls measured by fall diary
Reduction in incontinence related stigma and quality of life1 yearMeasured with the Incontinence Quality of Life questionnaire (IQOL)

Other

MeasureTime frameDescription
Cost-utility of the continence promotion intervention1-yearCost/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.

Countries

Canada, France, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026