Urinary IncontinenceNCT02453100
Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh
A study testing Mobility and pelvic floor exercise and Education in people with Urinary Incontinence, run by University of Alberta at 1 site in Canada.
Trial summary
An intervention consisting of group and home based exercise will be used over 6 months to assess whether this is helpful in managing urinary incontinence in elderly village women in Bangladesh. This intervention, supplemented by education about managing incontinence, will be used in half the villages in the trial. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Mobility and pelvic floor exercise and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 579 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Jul 2018
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 60-75 years reporting incontinence on a screening questionnaire (yes to questions 2,3or 4 on the 6 item Urinary Distress Index)
Who cannot join
- They report a uterine prolapse which is (or becomes) known to be of 3rd degree or higher.
- They are assessed by the village paramedic to be incapable of standing from sitting without help from someone else.
- They are assessed by the village paramedic to be unable to walk without help at a normal pace for someone of her age.
- They are assessed by the village paramedic as not having the intellectual capacity to understand questions and follow instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh: a Cluster Randomized Trial of a Community Exercise-based Intervention
An intervention consisting of group and home based exercise will be used over 6 months to assess whether this is helpful in managing urinary incontinence in elderly village women in Bangladesh. This intervention, supplemented by education about managing incontinence, will be used in half the villages in the trial. In the other half women will receive only the education component.
Read the detailed description
This is a cluster randomized trial in which all women aged 60-75 years reporting symptoms of urinary incontinence are randomly assigned, by village of residence, to either exercise plus education of to education alone.
- Conditions
- Urinary Incontinence
- Being tested
- Mobility and pelvic floor exercise, Education
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility and pelvic floor exerciseBehavioural
Mobility and pelvic floor exercises
EducationBehavioural
Education on simple ways to manage incontinence
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Women will be included in group mobility and pelvic floor exercise classes for one and a half hours twice weekly for 12 weeks and encouraged to carry out independent exercises each day when there is no group session.
A research paramedics will meet with the woman each month for six months from the initial training session to encourage her continued participation and adherence to the individual exercise program. At this meeting the research paramedic will also provide and reinforce simple education about how to manage urinary incontinence. Receives: Behavioral: Mobility and pelvic floor exercise; Behavioral: Education |
| Education | Placebo comparator | On recruitment and each month for six months a research paramedic will meet with each woman to provide and reinforce simple education about how to manage urinary incontinence. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of involuntary leakage of urine
The frequency of involuntary leakage over 3 days will be measured at each time point
Measured: Baseline and 24 weeks
Secondary outcomes (5)
Frequency of micturition
The frequency of micturition over 3 days will be measured at each time point
Measured: Baseline and 24 weeks
Severity of urinary symptoms
Urinary symptoms measured by the 2 item Sandvick index of severity
Measured: Baseline, 12 weeks and 24 weeks
Depression as measured on a Bangla version of the 10 item Center for Epidemiological Studies Depression Scale (CES-D 10)
Depression as measured on a Bangla version of the CES-D 10
Measured: Baseline, 12 weeks and 24 weeks
Quality of life as measured by a Bangla version of the Euroqol 5 dimension scale (EQ-5D)
Quality of life as measured by a Bangla version of the EQ-5D
Measured: Baseline and 24 weeks
Distress caused by urinary symptoms
Distress measured by the 6 item Urinary Distress Index
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Gonoshasthaya Kendra Bangladesh
- Responsible party
- Principal investigator, Nicola Cherry, University of Alberta
- Investigators
- Nicola M Cherry, MD PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453100
- Sponsor's protocol ID
- RES0022238
- Status last verified
- Apr 2019
- First submitted
- 19 May 2015
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wagg A, Chowdhury Z, Galarneau JM, Haque R, Kabir F, MacDonald D, Naher K, Yasui Y, Cherry N. Exercise intervention in the management of urinary incontinence in older women in villages in Bangladesh: a cluster randomised trial. Lancet Glob Health. 2019 Jul;7(7):e923-e931. doi: 10.1016/S2214-109X(19)30205-0.
PubMed 31200891
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh: a Cluster Randomized Trial of a Community Exercise-based Intervention
- ClinicalTrials.gov ID
- NCT02453100
- Acronym / sponsor ID
- RES0022238
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Gonoshasthaya Kendra Bangladesh
- Study start
- Jun 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 May 2015 (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.
An intervention consisting of group and home based exercise will be used over 6 months to assess whether this is helpful in managing urinary incontinence in elderly village women in Bangladesh. This intervention, supplemented by education about managing incontinence, will be used in half the villages in the trial. In the other half women will receive only the education component.
Detailed description
This is a cluster randomized trial in which all women aged 60-75 years reporting symptoms of urinary incontinence are randomly assigned, by village of residence, to either exercise plus education of to education alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Mobility and pelvic floor exercise, Behavioral: EducationWomen will be included in group mobility and pelvic floor exercise classes for one and a half hours twice weekly for 12 weeks and encouraged to carry out independent exercises each day when there is no group session. A research paramedics will meet with the woman each month for six months from the initial training session to encourage her continued participation and adherence to the individual exercise program. At this meeting the research paramedic will also provide and reinforce simple education about how to manage urinary incontinence. |
| Education | Placebo comparator | Behavioral: EducationOn recruitment and each month for six months a research paramedic will meet with each woman to provide and reinforce simple education about how to manage urinary incontinence. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged 60-75 years reporting incontinence on a screening questionnaire (yes to questions 2,3or 4 on the 6 item Urinary Distress Index)
Key exclusion criteria (4 listed)
- They report a uterine prolapse which is (or becomes) known to be of 3rd degree or higher.
- They are assessed by the village paramedic to be incapable of standing from sitting without help from someone else.
- They are assessed by the village paramedic to be unable to walk without help at a normal pace for someone of her age.
- They are assessed by the village paramedic as not having the intellectual capacity to understand questions and follow instructions.
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 |
|---|---|---|
| Mobility and pelvic floor exerciseMobility and pelvic floor exercises | Behavioural | Exercise |
| EducationEducation on simple ways to manage incontinence | Behavioural | Education, Exercise |
Primary outcome
Frequency of involuntary leakage of urine
Time frame: Baseline and 24 weeks
The frequency of involuntary leakage over 3 days will be measured at each time point
5 secondary outcomes
Frequency of micturition
Time frame: Baseline and 24 weeks
Severity of urinary symptoms
Time frame: Baseline, 12 weeks and 24 weeks
Depression as measured on a Bangla version of the 10 item Center for Epidemiological Studies Depression Scale (CES-D 10)
Time frame: Baseline, 12 weeks and 24 weeks
Quality of life as measured by a Bangla version of the Euroqol 5 dimension scale (EQ-5D)
Time frame: Baseline and 24 weeks
Distress caused by urinary symptoms
Time frame: Baseline and 24 weeks
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 19 Apr 2019.
- Derived from this study: PubMed 31200891Wagg A, Chowdhury Z, Galarneau JM, Haque R, Kabir F, MacDonald D, Naher K, Yasui Y, Cherry N. Exercise intervention in the management of urinary incontinence in older women in villages in Bangladesh: a cluster randomised trial. Lancet Glob Health. 2019 Jul;7(7):e923-e931. doi: 10.1016/S2214-109X(19)30205-0.
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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.
Nicola M Cherry, MD PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility and pelvic floor exercise and Education in people with Urinary Incontinence, run by University of Alberta at 1 site in Canada.
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 1 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 19 Apr 2019. 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 Canada. 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?
Frequency of involuntary leakage of urine (time frame: Baseline and 24 weeks). 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 NCT02453100, which also lists 1 linked publication.
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 19 Apr 2019.