Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

University of Alberta

Status: Completed

Conditions: Urinary Incontinence

Treatments: Behavioral: Mobility and pelvic floor exercise; Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02453100

RES0022238

Details and patient eligibility

About

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.

Full 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.

Enrollment: 579 patients

Sex: Female

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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579 participants in 2 patient groups, including a placebo group

Exercise

Experimental group

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.

Treatment:

Behavioral: Education

Behavioral: Mobility and pelvic floor exercise

Education

Placebo Comparator group

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.

Treatment:

Behavioral: Education