Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239836
• Other study ID #: CIHR-200909-CUK-202417
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: May 14, 2013
• Start date: September 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Brunel University Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Behavioral:
• 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.
• 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.
• General health lecture
Participants will attend a lecture on general women`s health issues that does not address urinary incontinence.

Locations

Country	Name	City	State
United Kingdom	Brunel University	Uxbridge	Middlesex

Sponsors (3)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal	Brunel University, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence frequency	Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.	3 months	No
Secondary	Cost of pad use	Reductions in the cost of pad use per day at 3-months post intervention compared to baseline.	3 months	No
Secondary	Self-efficacy for managing incontinence	An increase of 5 points or more on the Geriatric Self-Efficacy index for urinary incontinence at 3-months post-intervention compared to baseline.	3-months	No