Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Behavioral: General health lecture; Behavioral: Evidence-based self-management tool; Behavioral: Constructivist interactive workshop on urinary incontinence

• Registration Number: NCT01239836
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 259

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
General Health Lecture	General health lecture	-
Self-management	Evidence-based self-management tool	-
Combined workshop and self-management	Evidence-based self-management tool	-
Combined workshop and self-management	Constructivist interactive workshop on urinary incontinence	-
Workshop	Constructivist interactive workshop on urinary incontinence	-

Primary Outcome Measures

Name	Time	Method
Incontinence frequency	3 months	Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Self-efficacy for managing incontinence	3-months	An increase of 5 points or more on the Geriatric Self-Efficacy index for urinary incontinence at 3-months post-intervention compared to baseline.
Cost of pad use	3 months	Reductions in the cost of pad use per day at 3-months post intervention compared to baseline.

Trial Locations

Locations (1)

Brunel University; 🇬🇧 Uxbridge, Middlesex, United Kingdom