Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

NCT ID: NCT02453100

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

579 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-07-31

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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

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.

Group Type EXPERIMENTAL

Mobility and pelvic floor exercise

Intervention Type BEHAVIORAL

Mobility and pelvic floor exercises

Education

Intervention Type BEHAVIORAL

Education on simple ways to manage incontinence

Education

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.

Group Type PLACEBO_COMPARATOR

Education

Intervention Type BEHAVIORAL

Education on simple ways to manage incontinence

Interventions

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Mobility and pelvic floor exercise

Mobility and pelvic floor exercises

Intervention Type BEHAVIORAL

Education

Education on simple ways to manage incontinence

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gonoshasthaya Kendra Bangladesh

UNKNOWN

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Nicola Cherry

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola M Cherry, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31200891 (View on PubMed)

Other Identifiers

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RES0022238

Identifier Type: -

Identifier Source: org_study_id

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