Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

NCT ID: NCT01239836

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-01-31

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Self-management

Group Type: EXPERIMENTAL

Evidence-based self-management tool

Intervention Type: 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

Group Type: SHAM_COMPARATOR

General health lecture

Intervention Type: BEHAVIORAL

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

Combined workshop and self-management

Group Type: EXPERIMENTAL

Constructivist interactive workshop on urinary incontinence

Intervention Type: 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

Intervention Type: 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.

Workshop

Group Type: EXPERIMENTAL

Constructivist interactive workshop on urinary incontinence

Intervention Type: 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.

Interventions

Constructivist interactive workshop on urinary incontinence

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.

Intervention Type: BEHAVIORAL

Evidence-based self-management tool

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.

Intervention Type: BEHAVIORAL

General health lecture

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brunel University

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Cara Tannenbaum

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cara Tannenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche de l'Institut universitaire de gériatrie de Montréal

Eleanor van den Heuvel, PhD

Role: STUDY_DIRECTOR

Brunel University

Locations

Brunel University

Uxbridge, Middlesex, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 19693950 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24334159 (View on PubMed)

Other Identifiers

CIHR-200909-CUK-202417

Identifier Type: -

Identifier Source: org_study_id