Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453100
• Other study ID #: RES0022238
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2018

Study information

• Verified date: April 2019
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Behavioral:
• Mobility and pelvic floor exercise
Mobility and pelvic floor exercises
• Education
Education on simple ways to manage incontinence

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Gonoshasthaya Kendra Bangladesh

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of involuntary leakage of urine	The frequency of involuntary leakage over 3 days will be measured at each time point	Baseline and 24 weeks
Secondary	Frequency of micturition	The frequency of micturition over 3 days will be measured at each time point	Baseline and 24 weeks
Secondary	Severity of urinary symptoms	Urinary symptoms measured by the 2 item Sandvick index of severity	Baseline, 12 weeks and 24 weeks
Secondary	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	Baseline, 12 weeks and 24 weeks
Secondary	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	Baseline and 24 weeks
Secondary	Distress caused by urinary symptoms	Distress measured by the 6 item Urinary Distress Index	Baseline and 24 weeks