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OpenTrials
Completed

NCT Number: NCT01858493

Continence Across Continents to Upend Stigma and Dependency

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.

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Key information

Conditions

Urinary Incontinence Behavior Falls, Accidental Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Social Behavior Social Stigma Stigma Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continence promotion group education workshop

Behavioral

Interactive group education workshop promoting continence

Sham health lecture

Behavioral

Interactive group education workshop about general health

Primary outcomes

  1. Self-reported improvement in urinary incontinence

    Time frame: 1 year

    Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS

Secondary outcomes

  1. Falls

    Time frame: 1 year

    Reduction in incontinence-related falls measured by fall diary

  2. Reduction in incontinence related stigma and quality of life

    Time frame: 1 year

    Measured with the Incontinence Quality of Life questionnaire (IQOL)

Other outcomes

  1. Cost-utility of the continence promotion intervention

    Time frame: 1-year

    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.

Sponsors and collaborators

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CACTUS-D

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 21, 2013
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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