Clinical trial NCT02453100: Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh
Official title: Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh: a Cluster Randomized Trial of a Community Exercise-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Gonoshasthaya Kendra Bangladesh
First posted: 2015-05-25
Enrollment: 579
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Frequency of involuntary leakage of urine
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Frequency of micturition
timeFrame: Baseline and 24 weeks
measure: Severity of urinary symptoms
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Depression as measured on a Bangla version of the 10 item Center for Epidemiological Studies Depression Scale (CES-D 10)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Quality of life as measured by a Bangla version of the Euroqol 5 dimension scale (EQ-5D)
timeFrame: Baseline and 24 weeks
measure: Distress caused by urinary symptoms
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Nicola M Cherry, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.