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Completed

NCT Number: NCT01239836

Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brunel University

Uxbridge, Middlesex, UB8 3PH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Constructivist interactive workshop on urinary incontinence

Behavioral

A one hour interactive group workshop aimed at contradicting commonly held beliefs and maladaptive practices about incontinence. The interactive continence workshop was designed to create cognitive dissonance and challenge these beliefs and practices, as well as to promote more effective therapeutic strategies for correcting urine leakage.

Evidence-based self-management tool

Behavioral

Participants will receive a customized evidence-based risk factor modification self-management tool targeting up to 6 risk factors and associated therapeutic strategies. The six risk factors are pelvic floor muscle weakness, consumption of caffeinated drinks, obesity, constipation, vision loss and smoking.

General health lecture

Behavioral

Participants will attend a lecture on general women's health issues that does not address urinary incontinence.

Primary outcomes

  1. Incontinence frequency

    Time frame: 3 months

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

Secondary outcomes

  1. Cost of pad use

    Time frame: 3 months

    Reductions in the cost of pad use per day at 3-months post intervention compared to baseline.

  2. Self-efficacy for managing incontinence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Brunel University
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2010
Registry last updated
May 15, 2013

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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