Clinical trial NCT01858493: Continence Across Continents to Upend Stigma and Dependency
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Falls, Accidental
Quality of Life
Stigma
Keywords: Urinary incontinence
Falls
Quality of life
Stigma
Community-dwelling older women
Continence promotion
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: Medical Research Council
name: Canadian Institutes of Health Research (CIHR)
name: Institut national de prevention et d'education pour la sante
First posted: 2013-05-21
Enrollment: 910
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported improvement in urinary incontinence
timeFrame: 1 year
Secondary outcomes:
measure: Falls
timeFrame: 1 year
measure: Reduction in incontinence related stigma and quality of life
timeFrame: 1 year
Other outcomes:
measure: Cost-utility of the continence promotion intervention
timeFrame: 1-year
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Montreal
country: Canada
facility: Institut universitaire de gériatrie de Montréal
state: Quebec
city: Poitiers
country: France
facility: Université de Poitiers
state: Poitou-Charentes
city: Uxbridge
country: United Kingdom
facility: University of Brunel
state: Middlesex
Study officials:
affiliation: Univeristé de Montréal
name: Cara Tannenbaum, MD. MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Adrian Wagg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brunel University
name: Eleanor van den Heuvel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Poitiers
name: Xavier Fritel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.