Continence Across Continents to Upend Stigma and Dependency

NCT01858493 | Completed

• 1 other identifier: ERA-AGE2 dossier28835
• Study Type: interventional
• Target: 910
• Locations: 3 countries
• Sites: 4

Brief Summary

To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.

Conditions

Urinary Incontinence; Falls, Accidental; Quality of Life; Stigma

Keywords

Urinary incontinence; Falls; Quality of life; Stigma; Community-dwelling older women; Continence promotion

Outcome Measures

Primary Outcomes (1)

• Self-reported improvement in urinary incontinence

  Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS

  1 year

Secondary Outcomes (2)

• Falls

  1 year

• Reduction in incontinence related stigma and quality of life

  1 year

Other Outcomes (1)

• Cost-utility of the continence promotion intervention

  1-year

Study Arms (2)

Continence promotion group education

EXPERIMENTAL

A single 1-hour continence promotion group education workshop, facilitated by the research coordinator, aimed at changing knowledge and beliefs about urinary incontinence and different treatment options. An evidence-based self-management tool will be distributed at the end of the workshop.

Behavioral: Continence promotion group education workshop

Sham health lecture

SHAM COMPARATOR

A single 1-hour group education workshop on other health topics of concern to older women such as memory, hearing, insomnia

Behavioral: Sham health lecture

Interventions

Continence promotion group education workshop BEHAVIORAL

Interactive group education workshop promoting continence

Continence promotion group education

Sham health lecture BEHAVIORAL

Interactive group education workshop about general health

Sham health lecture

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Women
• years and older
• Urinary incontinence at least once weekly

You may not qualify if:

• Living in residential or long-term care
• Received treatment for incontinence within the past year
• Dementia or other neurological conditions that preclude the ability to provide -Informed consent

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead
• Fonds de la Recherche en Santé du Québec: collaborator
• Medical Research Council: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Institut national de prevention et d'education pour la sante: collaborator

Study Sites (4)

University of Alberta

Edmonton, Alberta, T6G 2P4, Canada

Location

Institut universitaire de gériatrie de Montréal

Montreal, Quebec, H3W1W5, Canada

Location

Université de Poitiers

Poitiers, Poitou-Charentes, 86000, France

Location

University of Brunel

Uxbridge, Middlesex, UB8 3PH, United Kingdom

Location

Related Publications (4)

• Agnew R, van den Heuvel E, Tannenbaum C. Efficiency of using community organisations as catalysts for recruitment to continence promotion trials. Clin Trials. 2013 Feb;10(1):151-9. doi: 10.1177/1740774512460144. Epub 2012 Oct 5.

  PMID: 23043154 BACKGROUND

• 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.

  PMID: 24334159 BACKGROUND

• Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  PMID: 39360568 DERIVED

• Tannenbaum C, van den Heuvel E, Fritel X, Southall K, Jutai J, Rajabali S, Wagg A. Continence Across Continents To Upend Stigma and Dependency (CACTUS-D): study protocol for a cluster randomized controlled trial. Trials. 2015 Dec 10;16:565. doi: 10.1186/s13063-015-1099-x.

  PMID: 26652168 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Social Stigma

Condition Hierarchy (Ancestors)

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

Study Officials

• Cara Tannenbaum, MD. MSc

  Univeristé de Montréal

  PRINCIPAL INVESTIGATOR

• Adrian Wagg, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Eleanor van den Heuvel, PhD

  Brunel University

  PRINCIPAL INVESTIGATOR

• Xavier Fritel, MD, PhD

  University of Poitiers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

GB (1); CA (2); FR (1)