Functional Urinary Incontinence Clinical Trial
— DUETOfficial title:
Preventing Toileting Disability in Frail Older Women
| NCT number | NCT02206958 |
| Other study ID # | 1112S07944 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2014 |
| Est. completion date | February 2016 |
| Verified date | May 2019 |
| Source | University of Minnesota - Clinical and Translational Science Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 60 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Minnesota School of Nursing | Minneapolis | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| University of Minnesota - Clinical and Translational Science Institute |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 3 day bladder diary | baseline, after completing 12 week intevention | ||
| Secondary | Short Physical Performance Battery | Performance based test of balance, gait, and chair rising ability. | baseline, after completing 12 week intervention | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |