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| Name | Class |
|---|---|
| Gonoshasthaya Kendra Bangladesh | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobility and pelvic floor exercise | Behavioral | Mobility and pelvic floor exercises |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola M Cherry, MD PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2T4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31200891 | Derived | 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. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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| Education |
| Behavioral |
Education on simple ways to manage incontinence |
|
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |