Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

Study Overview
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Brief Summary
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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
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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.

Official Title
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Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh: a Cluster Randomized Trial of a Community Exercise-based Intervention

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Behavioral: Mobility and pelvic floor exercise
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 60-75 years reporting incontinence on a screening questionnaire (yes to questions 2,3or 4 on the 6 item Urinary Distress Index) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>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. | Behavioral: Mobility and pelvic floor exercise<br>* Mobility and pelvic floor exercises<br>Behavioral: Education<br>* Education on simple ways to manage incontinence<br>|
| Placebo Comparator: Education<br>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. | Behavioral: Education<br>* Education on simple ways to manage incontinence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of involuntary leakage of urine | The frequency of involuntary leakage over 3 days will be measured at each time point | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of micturition | The frequency of micturition over 3 days will be measured at each time point | Baseline and 24 weeks | 
| Severity of urinary symptoms | Urinary symptoms measured by the 2 item Sandvick index of severity | 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 | 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 | Baseline and 24 weeks | 
| Distress caused by urinary symptoms | Distress measured by the 6 item Urinary Distress Index | Baseline and 24 weeks |