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Completed

NCT Number: NCT02206958

Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study

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.

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Key information

Conditions

Toileting Disability Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Functional Urinary Incontinence Lower Urinary Tract Symptoms Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota School of Nursing

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Defeating Urinary Incontinence with Exercise Training

Behavioral

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.

  • 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 outcomes

  1. Performance Oriented Timed Toileting Instrument (POTTI)

    Time frame: 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).

  2. Toileting Skills Questionnaire

    Time frame: 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 outcomes

  1. International Consultation on Incontinence Questionnaire (ICIQ)

    Time frame: 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.

  2. 3 day bladder diary

    Time frame: baseline, after completing 12 week intevention

  3. Short Physical Performance Battery

    Time frame: baseline, after completing 12 week intervention

    Performance based test of balance, gait, and chair rising ability.

  4. Environmental toileting barriers checklist

    Time frame: 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.

  5. Incontinence Impact Questionnaire (IIQ)

    Time frame: 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.

  6. Urogenital Distress Inventory (UDI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Preventing Toileting Disability in Frail Older Women

Acronym: DUET

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2014
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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