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Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

Not Applicable
Completed
Conditions
Urinary Incontinence
Interventions
Behavioral: Education
Behavioral: Mobility and pelvic floor exercise
Registration Number
NCT02453100
Lead Sponsor
University of Alberta
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
579
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)
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EducationEducationOn 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.
ExerciseMobility and pelvic floor exerciseWomen 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.
ExerciseEducationWomen 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.
Primary Outcome Measures
NameTimeMethod
Frequency of involuntary leakage of urineBaseline and 24 weeks

The frequency of involuntary leakage over 3 days will be measured at each time point

Secondary Outcome Measures
NameTimeMethod
Quality of life as measured by a Bangla version of the Euroqol 5 dimension scale (EQ-5D)Baseline and 24 weeks

Quality of life as measured by a Bangla version of the EQ-5D

Distress caused by urinary symptomsBaseline and 24 weeks

Distress measured by the 6 item Urinary Distress Index

Depression as measured on a Bangla version of the 10 item Center for Epidemiological Studies Depression Scale (CES-D 10)Baseline, 12 weeks and 24 weeks

Depression as measured on a Bangla version of the CES-D 10

Frequency of micturitionBaseline and 24 weeks

The frequency of micturition over 3 days will be measured at each time point

Severity of urinary symptomsBaseline, 12 weeks and 24 weeks

Urinary symptoms measured by the 2 item Sandvick index of severity

Trial Locations

Locations (1)

University of Alberta

🇨🇦

Edmonton, Alberta, Canada

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