Urinary IncontinenceCACTUS-DNCT01858493
Continence Across Continents to Upend Stigma and Dependency
A study testing Continence promotion group education workshop in people with Urinary Incontinence and Falls, Accidental, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Falls, Accidental, Quality of Life
- What is being tested?
- Continence promotion group education workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 910 participants
- Where
- 4 sitesin 3 countries
- Study dates
- May 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Women
- 65 years and older
- Urinary incontinence at least once weekly
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 2P4
Institut universitaire de gériatrie de Montréal
Montreal, Quebec, H3W1W5
About this study
Official title: Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence
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.
Read the detailed description
This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on:
- Improved urinary symptoms and quality of life
- Reduction in falls
- Reduction in stigma
A cost-effectiveness component will also be included
- Conditions
- Urinary Incontinence, Falls, Accidental, Quality of Life, Stigma
- Being tested
- Continence promotion group education workshop, Sham health lecture
- Keywords
- Urinary incontinence, Falls, Quality of life, Stigma, Community-dwelling older women, Continence promotion
- Medical subject headings
- Urinary Incontinence, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continence promotion group education workshopBehavioural
Interactive group education workshop promoting continence
Sham health lectureBehavioural
Interactive group education workshop about general health
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Sham health lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported improvement in urinary incontinence
Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS
Measured: 1 year
Secondary outcomes (2)
Falls
Reduction in incontinence-related falls measured by fall diary
Measured: 1 year
Reduction in incontinence related stigma and quality of life
Measured with the Incontinence Quality of Life questionnaire (IQOL)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 910 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Medical Research Council, Canadian Institutes of Health Research (CIHR), Institut national de prevention et d'education pour la sante
- Responsible party
- Principal investigator, Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Cara Tannenbaum, MD. MSc, Principal investigator, Univeristé de MontréalAdrian Wagg, MD, Principal investigator, University of AlbertaEleanor van den Heuvel, PhD, Principal investigator, Brunel UniversityXavier Fritel, MD, PhD, Principal investigator, University of Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858493
- Sponsor's protocol ID
- ERA-AGE2 dossier28835
- Acronym
- CACTUS-D
- Status last verified
- Jul 2017
- First submitted
- 14 May 2013
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23043154Tannenbaum 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.
PubMed 24334159Drahota 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.
PubMed 39360568Tannenbaum 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.
PubMed 26652168
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence
- ClinicalTrials.gov ID
- NCT01858493
- Acronym / sponsor ID
- CACTUS-D / ERA-AGE2 dossier28835
- Conditions
- Urinary Incontinence, Falls, Accidental, Quality of Life, Stigma
- Keywords
- Urinary incontinence, Falls, Quality of life, Stigma, Community-dwelling older women, Continence promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 910 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Medical Research Council, Canadian Institutes of Health Research (CIHR), Institut national de prevention et d'education pour la sante
- Study start
- May 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on:
- Improved urinary symptoms and quality of life
- Reduction in falls
- Reduction in stigma
A cost-effectiveness component will also be included
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continence promotion group education | Experimental | Behavioral: Continence promotion group education workshopA 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. |
| Sham health lecture | Sham comparator | Behavioral: Sham health lectureA single 1-hour group education workshop on other health topics of concern to older women such as memory, hearing, insomnia |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Women
- 65 years and older
- Urinary incontinence at least once weekly
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continence promotion group education workshopInteractive group education workshop promoting continence | Behavioural | Continence promotion group education |
| Sham health lectureInteractive group education workshop about general health | Behavioural | Sham health lecture |
Primary outcome
Self-reported improvement in urinary incontinence
Time frame: 1 year
Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS
2 secondary outcomes
Falls
Time frame: 1 year
Reduction in incontinence related stigma and quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Background: PubMed 23043154Agnew 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.
- Background: PubMed 24334159Tannenbaum 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.
- Derived from this study: PubMed 39360568Drahota 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.
- Derived from this study: PubMed 26652168Tannenbaum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara Tannenbaum, MD. MSc principal investigator
Univeristé de Montréal
Adrian Wagg, MD principal investigator
University of Alberta
Eleanor van den Heuvel, PhD principal investigator
Brunel University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continence promotion group education workshop in people with Urinary Incontinence and Falls, Accidental, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported improvement in urinary incontinence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01858493, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017; AzTrials last refreshed its copy on 5 Nov 2026.