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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Behavioral: Mobility and pelvic floor exercise; Behavioral: Education

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.

• Study Type: Interventional
• Enrollment (Actual): 579
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2T4
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mobility and pelvic floor exercise; Mobility and pelvic floor exercises; Behavioral: Education; Education on simple ways to manage incontinence
Placebo Comparator: 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.	Behavioral: Education; Education on simple ways to manage incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of micturition	The frequency of micturition over 3 days will be measured at each time point	Baseline and 24 weeks
Severity of urinary symptoms	Urinary symptoms measured by the 2 item Sandvick index of severity	Baseline, 12 weeks and 24 weeks
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
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
Distress caused by urinary symptoms	Distress measured by the 6 item Urinary Distress Index	Baseline and 24 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Gonoshasthaya Kendra Bangladesh
• Investigators: Principal Investigator: Nicola M Cherry, MD PhD, University of Alberta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: RES0022238