Back to resultsManaging Urinary Incontinence in Elderly Village Women in Rural Bangladesh
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mobility and pelvic floor exercise
Education
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise
Education
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Frequency of involuntary leakage of urine
The frequency of involuntary leakage over 3 days will be measured at each time point
Secondary Outcome Measures
Frequency of micturition
The frequency of micturition over 3 days will be measured at each time point
Severity of urinary symptoms
Urinary symptoms measured by the 2 item Sandvick index of severity
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
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
Distress caused by urinary symptoms
Distress measured by the 6 item Urinary Distress Index
Full Information
NCT ID
NCT02453100
First Posted
May 19, 2015
Last Updated
April 17, 2019
Sponsor
University of Alberta
Collaborators
Gonoshasthaya Kendra Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT02453100
Brief Title
Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh
Official Title
Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh: a Cluster Randomized Trial of a Community Exercise-based Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Gonoshasthaya Kendra Bangladesh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
579 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Education
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobility and pelvic floor exercise
Intervention Description
Mobility and pelvic floor exercises
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Education on simple ways to manage incontinence
Primary Outcome Measure Information:
Title
Frequency of involuntary leakage of urine
Description
The frequency of involuntary leakage over 3 days will be measured at each time point
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Frequency of micturition
Description
The frequency of micturition over 3 days will be measured at each time point
Time Frame
Baseline and 24 weeks
Title
Severity of urinary symptoms
Description
Urinary symptoms measured by the 2 item Sandvick index of severity
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Depression as measured on a Bangla version of the 10 item Center for Epidemiological Studies Depression Scale (CES-D 10)
Description
Depression as measured on a Bangla version of the CES-D 10
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Quality of life as measured by a Bangla version of the Euroqol 5 dimension scale (EQ-5D)
Description
Quality of life as measured by a Bangla version of the EQ-5D
Time Frame
Baseline and 24 weeks
Title
Distress caused by urinary symptoms
Description
Distress measured by the 6 item Urinary Distress Index
Time Frame
Baseline and 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola M Cherry, MD PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2T4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
31200891
Citation
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.
Results Reference
derived
Learn more about this trial
Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh
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