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Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study (DUET)

Primary Purpose

Toileting Disability, Functional Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Defeating Urinary Incontinence with Exercise Training
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toileting Disability focused on measuring Toileting disability, Functional urinary incontinence, Urinary incontinence, Frailty, Physical activity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

No treatment control group

Behavioral Urinary Incontinence Treatment

Arm Description

No treatment control group

12 week program combining behavioral treatments for urinary incontinence and physical activity

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
3 day bladder diary
Short Physical Performance Battery
Performance based test of balance, gait, and chair rising ability.
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.
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.
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.

Full Information

First Posted
July 30, 2014
Last Updated
May 1, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02206958
Brief Title
Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study
Acronym
DUET
Official Title
Preventing Toileting Disability in Frail Older Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toileting Disability, Functional Urinary Incontinence
Keywords
Toileting disability, Functional urinary incontinence, Urinary incontinence, Frailty, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No treatment control group
Arm Type
Other
Arm Description
No treatment control group
Arm Title
Behavioral Urinary Incontinence Treatment
Arm Type
Experimental
Arm Description
12 week program combining behavioral treatments for urinary incontinence and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Defeating Urinary Incontinence with Exercise Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance Oriented Timed Toileting Instrument (POTTI)
Description
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).
Time Frame
baseline, after completing 12 week intervention
Title
Toileting Skills Questionnaire
Description
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.
Time Frame
baseline, after completing 12 week intervention
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire (ICIQ)
Description
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.
Time Frame
baseline, after completing 12 week intervention
Title
3 day bladder diary
Time Frame
baseline, after completing 12 week intevention
Title
Short Physical Performance Battery
Description
Performance based test of balance, gait, and chair rising ability.
Time Frame
baseline, after completing 12 week intervention
Title
Environmental toileting barriers checklist
Description
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.
Time Frame
baseline
Title
Incontinence Impact Questionnaire (IIQ)
Description
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.
Time Frame
baseline, after completing 12 week intervention
Title
Urogenital Distress Inventory (UDI)
Description
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.
Time Frame
baseline, after completing 12 week intevention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Minnesota School of Nursing
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28248418
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.
Results Reference
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Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study

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