Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study

Not Applicable

Completed

• Conditions: Toileting Disability; Functional Urinary Incontinence
• Interventions: Behavioral: Defeating Urinary Incontinence with Exercise Training

• Registration Number: NCT02206958
• Lead Sponsor: University of Minnesota

Brief Summary

Pilot study to determine the feasibility and possible treatment effect of a multi-component intervention combining non-drug treatments for urinary incontinence and physical activity to improve urinary incontinence, toileting skills, physical function, and quality of life in frail older women without dementia living in senior housing facilities.

Detailed Description

This was a single blinded, two-arm pilot randomized controlled trial designed to test the feasibility and potential treatment effects of a multi-component intervention that combined behavioral urinary incontinence treatments with physical activity to improve urinary incontinence, toileting skills, quality of life, and physical function in frail older women without dementia living in senior apartment buildings.The intervention included a 12-week program of tailored behavioral UI treatments delivered by a nurse practitioner during 4 home visits, 150 minutes of weekly walking, and twice weekly strength training classes.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• Female
• Age 60 years or older
• Have urinary incontinence
• Not currently meeting national recommendations for physical activity (150 minutes of weekly moderate intensity aerobic exercise and twice weekly strength building exercise.
• At risk for functional decline per the Vulnerable Elders Survey (score of 3+)
• Free of dementia (pass mini-cog screening)

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Exclusion Criteria

• Cognitive impairment
• Grade 4 vaginal prolapse or pessary use
• Orthopedic surgery in past year
• Urinary retention (catheter use)
• Neurological cause for urinary incontinence (i.e. Parkinson's Disease, MS)
• Bladder cancer
• Bladder or incontinence surgery in past year
• Recipient of hospice or palliative care
• Ostomy
• New prescription or dosage change in past three months for anti-incontinence medication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Urinary Incontinence Treatment	Defeating Urinary Incontinence with Exercise Training	12 week program combining behavioral treatments for urinary incontinence and physical activity
No treatment control group	Defeating Urinary Incontinence with Exercise Training	No treatment control group

Primary Outcome Measures

Name	Time	Method
Performance Oriented Timed Toileting Instrument (POTTI)	baseline, after completing 12 week intervention	A performance based measure that takes less than 5 minutes to administer. Participants are timed as they complete tasks that simulate toileting including: rising from a chair, walking 15 feet to another chair, turning around, pulling down an elastic waist skirt worn over their typical clothing, sitting in the chair, grabbing a piece of toileting paper and throwing it into a wastebasket, rising and pulling the skirt back up. Longer times indicate greater difficulty with toileting. It has strong inter-rater and test-retest reliability (90% agreement) and has been validated with activities of daily living dependency (r= -.721, p\<.001) in nursing home residents (Ouslander et al., 1987). It has demonstrated responsiveness to change in a recent clinical trial (van Houten et. al., 2007).
Toileting Skills Questionnaire	baseline, after completing 12 week intervention	A five item toileting skills questionnaire that assesses participants level of difficulty with undressing, walking to the toilet, getting on and off the toilet, reaching to grab toilet paper, and reaching around to wipe their bottom. Responses for each item range from 0-no difficulty to 4-cannot do. Total scores range from 0-20. Higher scores indicate more difficulty.

Secondary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Questionnaire (ICIQ)	baseline, after completing 12 week intervention	A four item questionnaire reporting the frequency and amount of urine leakage, how much leakage interferes with everyday life, and when leaking occurs. Scores range from 0-21 with higher scores indicating greater severity.
3 day bladder diary	baseline, after completing 12 week intevention
Incontinence Impact Questionnaire (IIQ)	baseline, after completing 12 week intervention	The IIQ is a questionnaire with 30 items measuring the impact urinary incontinence has on social, physical, emotional, and psychological aspects of life. All items contain the same response options (0=not at all, 1=slightly, 2= moderately, 3=greatly) and scores range from 0-90.
Urogenital Distress Inventory (UDI)	baseline, after completing 12 week intevention	The UDI has 20 items asking about how much urinary incontinence bothers the respondent. All items contain the same response options (0=not at all, 1=slightly, 2= moderately, 3=greatly) and scores range from 0-60.
Environmental toileting barriers checklist	baseline	Observation of environmental barriers to toilet access, i.e., inappropriate toilet seat height, grab bar placement, trip hazards on pathway to toilet, adequate lighting in bathroom and pathways to toilet and other barriers to easy toileting.
Short Physical Performance Battery	baseline, after completing 12 week intervention	Performance based test of balance, gait, and chair rising ability.

Trial Locations

Locations (1)

University of Minnesota School of Nursing; 🇺🇸 Minneapolis, Minnesota, United States