Urinary IncontinenceNCT01239836
Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women
A study testing Constructivist interactive workshop on urinary incontinence, Evidence-based self-management tool and General health lecture in people with Urinary Incontinence, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Constructivist interactive workshop on urinary incontinence, Evidence-based self-management tool and General health lecture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Jan 2013
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Constructivist interactive workshop on urinary incontinence, Evidence-based self-management tool, General health lecture
- Keywords
- urinary incontinence, self-management, cost, self-efficacy, continence promotion
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constructivist interactive workshop on urinary incontinenceBehavioural
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 toolBehavioural
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 lectureBehavioural
Participants will attend a lecture on general women's health issues that does not address urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Self-management | Experimental | Not described Receives: Behavioral: Evidence-based self-management tool |
| General Health Lecture | Sham comparator | Not described Receives: Behavioral: General health lecture |
| Combined workshop and self-management | Experimental | Not described Receives: Behavioral: Constructivist interactive workshop on urinary incontinence; Behavioral: Evidence-based self-management tool |
| Workshop | Experimental | Not described Receives: Behavioral: Constructivist interactive workshop on urinary incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence frequency
Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.
Measured: 3 months
Secondary outcomes (2)
Cost of pad use
Reductions in the cost of pad use per day at 3-months post intervention compared to baseline.
Measured: 3 months
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.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 259 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
- Brunel University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Cara Tannenbaum, MD, Principal investigator, Centre de recherche de l'Institut universitaire de gériatrie de MontréalEleanor van den Heuvel, PhD, Study director, Brunel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239836
- Sponsor's protocol ID
- CIHR-200909-CUK-202417
- Status last verified
- May 2013
- First submitted
- 10 Nov 2010
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19693950Tannenbaum 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 24334159
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01239836
- Acronym / sponsor ID
- CIHR-200909-CUK-202417
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, self-management, cost, self-efficacy, continence promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Collaborators
- Brunel University, Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Nov 2010 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Self-management | Experimental | Behavioral: Evidence-based self-management tool |
| General Health Lecture | Sham comparator | Behavioral: General health lecture |
| Combined workshop and self-management | Experimental | Behavioral: Constructivist interactive workshop on urinary incontinence, Behavioral: Evidence-based self-management tool |
| Workshop | Experimental | Behavioral: Constructivist interactive workshop on urinary incontinence |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Constructivist interactive workshop on urinary incontinenceA 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. | Behavioural | Combined workshop and self-management, Workshop |
| Evidence-based self-management toolParticipants 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. | Behavioural | Combined workshop and self-management, Self-management |
| General health lectureParticipants will attend a lecture on general women's health issues that does not address urinary incontinence. | Behavioural | General Health Lecture |
Primary outcome
Incontinence frequency
Time frame: 3 months
Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.
2 secondary outcomes
Cost of pad use
Time frame: 3 months
Self-efficacy for managing incontinence
Time frame: 3-months
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 15 May 2013.
- Background: PubMed 19693950Tannenbaum 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.
- Derived from this study: 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.
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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 principal investigator
Centre de recherche de l'Institut universitaire de gériatrie de Montréal
Eleanor van den Heuvel, PhD study director
Brunel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constructivist interactive workshop on urinary incontinence, Evidence-based self-management tool and General health lecture in people with Urinary Incontinence, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in United Kingdom.
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 5 inclusion and 4 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 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Incontinence frequency (time frame: 3 months). 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 NCT01239836, which also lists 2 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 15 May 2013.