Clinical trial NCT01239836: Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women
Official title: Self-management, Constructivism or Both as Knowledge Transfer Strategies for Reducing the Cost and Impact of Urinary Incontinence Among Community-dwelling Senior Women in the United Kingdom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence, self-management, cost, self-efficacy, continence promotion
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
Collaborators: name: Brunel University
name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-11-11
Enrollment: 259
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Urinary incontinence is a common and bothersome condition that remains frequently untreated among senior women. The aim of this trial is to compare the effectiveness of two community-based continence promotion interventions aimed at improving rates of self-care and/or professional health-care seeking in older women with urinary incontinence. The main hypothesis posits that participation in a constructivist interactive workshop combined with use of an evidence-based self-management tool will yield rates of improvement in incontinence frequency and reduce the cost of pad use by 20% compared to either intervention alone, which individually are expected to yield minimal effect sizes of at least 0.3 compared to a sham intervention.

Detailed description: The research design is a 2x2 factorial open-label cluster randomised controlled trial. The cluster (unit of randomization) is at the level of each local community senior's group, from whence participants will be recruited. Incontinent community-dwelling older women aged 60 years and older who have not sought care for their urinary symptoms in the last two years, but who experience incontinence at least twice weekly will be recruited through local community organizations. Eligible participants from each local community centre will be randomly assigned as a group to one of four interventions. The first intervention is participation in an interactive constructivist continence workshop. The second intervention involves receipt of an evidence-based self-management tool for incontinence. The third group will receive both interventions. The fourth group will act as the control group: they will simply be asked about their urinary symptoms and given a general talk on women's health. At the end of the study, the control group will be offered the self-management tool.

Eligibility criteria: Inclusion Criteria:

* Female
* 60 years or older
* Urinary incontinence twice weekly
* Women who have not sought medical advice for incontinence symptoms in the last 2 years.
* Fluent in English

Exclusion Criteria:

* Women who have received treatment for their urinary incontinence within the past two years from a health care provider with expertise in urinary incontinence management (i.e. nurse practitioners/physicians/surgeons who have a clinical practice that focuses on treating urinary incontinence).
* Women started on medications for urinary incontinence (i.e. antimuscarinic medication) within the 6 months prior to enrolment.
* Women with a history of a neurological condition (e.g. Multiple Sclerosis and spinal cord injury) because they require further investigation. Women identified to have these historical findings will be advised to speak to their physician immediately about their incontinence and the possible need for investigation.
* Women who do not consent to participate.

Primary outcomes:
measure: Incontinence frequency
timeFrame: 3 months
Secondary outcomes:
measure: Cost of pad use
timeFrame: 3 months
measure: Self-efficacy for managing incontinence
timeFrame: 3-months
Other outcomes:
Locations:
city: Uxbridge
country: United Kingdom
facility: Brunel University
state: Middlesex
Study officials:
affiliation: Centre de recherche de l'Institut universitaire de gériatrie de Montréal
name: Cara Tannenbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brunel University
name: Eleanor van den Heuvel, PhD
role: STUDY_DIRECTOR
References:
citation: Tannenbaum C, Drali R, Holroyd-Leduc J, Richard L. Lessons learned: impact of a continence promotion activity for older community-dwelling women. Neurourol Urodyn. 2010 Apr;29(4):540-4. doi: 10.1002/nau.20800.
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.