Skip to main content
OpenTrials
Completed

NCT Number: NCT02453100

Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

60 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2T4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobility and pelvic floor exercise

Behavioral

Mobility and pelvic floor exercises

Education

Behavioral

Education on simple ways to manage incontinence

Primary outcomes

  1. Frequency of involuntary leakage of urine

    Time frame: Baseline and 24 weeks

    The frequency of involuntary leakage over 3 days will be measured at each time point

Secondary outcomes

  1. Frequency of micturition

    Time frame: Baseline and 24 weeks

    The frequency of micturition over 3 days will be measured at each time point

  2. Severity of urinary symptoms

    Time frame: Baseline, 12 weeks and 24 weeks

    Urinary symptoms measured by the 2 item Sandvick index of severity

  3. Depression as measured on a Bangla version of the 10 item Center for Epidemiological Studies Depression Scale (CES-D 10)

    Time frame: Baseline, 12 weeks and 24 weeks

    Depression as measured on a Bangla version of the CES-D 10

  4. Quality of life as measured by a Bangla version of the Euroqol 5 dimension scale (EQ-5D)

    Time frame: Baseline and 24 weeks

    Quality of life as measured by a Bangla version of the EQ-5D

  5. Distress caused by urinary symptoms

    Time frame: Baseline and 24 weeks

    Distress measured by the 6 item Urinary Distress Index

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Gonoshasthaya Kendra Bangladesh

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 25, 2015
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.