NCT02453100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
579

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

May 19, 2015

Last Update Submit

April 17, 2019

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Frequency of micturition

    Baseline and 24 weeks

  • Severity of urinary symptoms

    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)

    Baseline, 12 weeks and 24 weeks

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

    Baseline and 24 weeks

  • Distress caused by urinary symptoms

    Baseline and 24 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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 exerciseBehavioral: Education

Education

PLACEBO COMPARATOR

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

Interventions

Mobility and pelvic floor exerciseBEHAVIORAL

Mobility and pelvic floor exercises

Exercise
EducationBEHAVIORAL

Education on simple ways to manage incontinence

EducationExercise

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 60-75 years reporting incontinence on a screening questionnaire (yes to questions 2,3or 4 on the 6 item Urinary Distress Index)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2T4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 31200891DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Range of Motion, ArticularEducational Status

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Nicola M Cherry, MD PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 25, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

CA(1)