Clinical trial NCT02206958: Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study
Official title: Preventing Toileting Disability in Frail Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toileting Disability
Functional Urinary Incontinence
Keywords: Toileting disability
Functional urinary incontinence
Urinary incontinence
Frailty
Physical activity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 42
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance Oriented Timed Toileting Instrument (POTTI)
timeFrame: baseline, after completing 12 week intervention
measure: Toileting Skills Questionnaire
timeFrame: baseline, after completing 12 week intervention
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire (ICIQ)
timeFrame: baseline, after completing 12 week intervention
measure: 3 day bladder diary
timeFrame: baseline, after completing 12 week intevention
measure: Short Physical Performance Battery
timeFrame: baseline, after completing 12 week intervention
measure: Environmental toileting barriers checklist
timeFrame: baseline
measure: Incontinence Impact Questionnaire (IIQ)
timeFrame: baseline, after completing 12 week intervention
measure: Urogenital Distress Inventory (UDI)
timeFrame: baseline, after completing 12 week intevention
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota School of Nursing
state: Minnesota
Study officials:
References:
citation: Talley KMC, Wyman JF, Bronas U, Olson-Kellogg BJ, McCarthy TC. Defeating Urinary Incontinence with Exercise Training: Results of a Pilot Study in Frail Older Women. J Am Geriatr Soc. 2017 Jun;65(6):1321-1327. doi: 10.1111/jgs.14798. Epub 2017 Mar 1.