Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

This study has been completed.
Sponsor:
Collaborators:
Brunel University
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier:
NCT01239836
First received: November 10, 2010
Last updated: May 14, 2013
Last verified: May 2013

November 10, 2010
May 14, 2013
September 2010
January 2013   (final data collection date for primary outcome measure)
Incontinence frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.
Same as current
Complete list of historical versions of study NCT01239836 on ClinicalTrials.gov Archive Site
  • Cost of pad use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reductions in the cost of pad use per day at 3-months post intervention compared to baseline.
  • Self-efficacy for managing incontinence [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    An increase of 5 points or more on the Geriatric Self-Efficacy index for urinary incontinence at 3-months post-intervention compared to baseline.
Same as current
Not Provided
Not Provided
 
Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Urinary Incontinence
  • 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.
  • 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.
  • Behavioral: General health lecture
    Participants will attend a lecture on general women`s health issues that does not address urinary incontinence.
  • Experimental: Self-management
    Intervention: Behavioral: Evidence-based self-management tool
  • Sham Comparator: General Health Lecture
    Intervention: Behavioral: General health lecture
  • Experimental: Combined workshop and self-management
    Interventions:
    • Behavioral: Constructivist interactive workshop on urinary incontinence
    • Behavioral: Evidence-based self-management tool
  • Experimental: Workshop
    Intervention: Behavioral: Constructivist interactive workshop on urinary incontinence
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
259
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Female
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01239836
CIHR-200909-CUK-202417
No
Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
  • Brunel University
  • Canadian Institutes of Health Research (CIHR)
Principal Investigator: Cara Tannenbaum, MD Centre de recherche de l'Institut universitaire de gériatrie de Montréal
Study Director: Eleanor van den Heuvel, PhD Brunel University
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP