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Trial record 2 of 674 for:    (elderly OR senior) AND incontinence AND (woman OR women OR female)

Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

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ClinicalTrials.gov Identifier: NCT02453100
Recruitment Status : Recruiting
First Posted : May 25, 2015
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Gonoshasthaya Kendra Bangladesh
Information provided by (Responsible Party):
Nicola Cherry, University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Behavioral: Mobility and pelvic floor exercise Behavioral: Education Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh: a Cluster Randomized Trial of a Community Exercise-based Intervention
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453100


Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2T4
Contact: Nicola M Cherry, MD PhD    780 492 7851    ncherry@ualberta.ca   
Contact: Adrian S Wagg, MB BS    780 492 1383    adrian.wagg@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Gonoshasthaya Kendra Bangladesh
Investigators
Principal Investigator: Nicola M Cherry, MD PhD University of Alberta

Responsible Party: Nicola Cherry, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02453100     History of Changes
Other Study ID Numbers: RES0022238
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders