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Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02453100
Enrollment
579
Registered
2015-05-25
Start date
2015-06-30
Completion date
2018-07-31
Last updated
2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

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.

Interventions

BEHAVIORALMobility and pelvic floor exercise

Mobility and pelvic floor exercises

BEHAVIORALEducation

Education on simple ways to manage incontinence

Sponsors

Gonoshasthaya Kendra Bangladesh
CollaboratorUNKNOWN
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of involuntary leakage of urineBaseline and 24 weeksThe frequency of involuntary leakage over 3 days will be measured at each time point

Secondary

MeasureTime frameDescription
Frequency of micturitionBaseline and 24 weeksThe frequency of micturition over 3 days will be measured at each time point
Severity of urinary symptomsBaseline, 12 weeks and 24 weeksUrinary 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)Baseline, 12 weeks and 24 weeksDepression 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)Baseline and 24 weeksQuality of life as measured by a Bangla version of the EQ-5D
Distress caused by urinary symptomsBaseline and 24 weeksDistress measured by the 6 item Urinary Distress Index

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026