Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preventing Toileting Disability in Frail Older Women

Conditions
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Toileting Disability, Functional Urinary Incontinence

Intervention / Treatment
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* Behavioral: Defeating Urinary Incontinence with Exercise Training


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No treatment control group<br>No treatment control group | Behavioral: Defeating Urinary Incontinence with Exercise Training<br>* 12 week multi-component program. Continence program administered by a nurse practitioner during 4 home visits. Participants do pelvic floor muscle exercises 5 days/week using a 13-minute instructional audio CD. Based on participant symptoms and preferences the following strategies are taught: bladder training, urge and suppression techniques, caffeine reduction, eliminating bladder irritants, medication adjustment, adequate fluid intake, constipation management, and reducing nocturia. 2. Physical activity program including moderate intensity walking (30 minutes, 5 days weekly) and twice weekly group strength training sessions using Therabands led by a trained exercise instructor.<br>|
| Experimental: Behavioral Urinary Incontinence Treatment<br>12 week program combining behavioral treatments for urinary incontinence and physical activity | Behavioral: Defeating Urinary Incontinence with Exercise Training<br>* 12 week multi-component program. Continence program administered by a nurse practitioner during 4 home visits. Participants do pelvic floor muscle exercises 5 days/week using a 13-minute instructional audio CD. Based on participant symptoms and preferences the following strategies are taught: bladder training, urge and suppression techniques, caffeine reduction, eliminating bladder irritants, medication adjustment, adequate fluid intake, constipation management, and reducing nocturia. 2. Physical activity program including moderate intensity walking (30 minutes, 5 days weekly) and twice weekly group strength training sessions using Therabands led by a trained exercise instructor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Oriented Timed Toileting Instrument (POTTI) | 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). | baseline, after completing 12 week intervention | 
| Toileting Skills Questionnaire | 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. | baseline, after completing 12 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence Questionnaire (ICIQ) | 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. | baseline, after completing 12 week intervention | 
| 3 day bladder diary |  | baseline, after completing 12 week intevention | 
| Short Physical Performance Battery | Performance based test of balance, gait, and chair rising ability. | baseline, after completing 12 week intervention | 
| Environmental toileting barriers checklist | 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. | baseline | 
| Incontinence Impact Questionnaire (IIQ) | 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. | baseline, after completing 12 week intervention | 
| Urogenital Distress Inventory (UDI) | 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. | baseline, after completing 12 week intevention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toileting disability, Functional urinary incontinence, Urinary incontinence, Frailty, Physical activity