Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

University Institute of Geriatrics of Montreal (IUGM)

Status: Completed

Conditions: Urinary Incontinence

Treatments: Behavioral: Evidence-based self-management tool; Behavioral: Constructivist interactive workshop on urinary incontinence; Behavioral: General health lecture

Study type: Interventional

Funder types: Other

Identifiers

NCT01239836

CIHR-200909-CUK-202417

Details and patient eligibility

About

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.

Full 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.

Enrollment: 259 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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259 participants in 4 patient groups

Self-management

Experimental group

Treatment:

Behavioral: Evidence-based self-management tool

General Health Lecture

Sham Comparator group

Treatment:

Behavioral: General health lecture

Combined workshop and self-management

Experimental group

Treatment:

Behavioral: Constructivist interactive workshop on urinary incontinence

Behavioral: Evidence-based self-management tool

Workshop

Experimental group

Treatment:

Behavioral: Constructivist interactive workshop on urinary incontinence