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Completed

NCT Number: NCT03057834

The Urinary Incontinence Treatment Study

Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If investigators find unequal numbers, they will adapt recruit strategies based on a woman's functional status.

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Key information

About this study

Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If they find unequal numbers, they will adapt recruit strategies based on a woman's functional status.

Investigators will compare changes in outcome measures within and between groups after 6 and 12 weeks of pelvic floor muscle exercises (PFME). The change in pelvic floor strength/efficiency will be assessed by repeating the pelvic floor PERFECT assessment and will be compared between groups. Changes in UI symptoms, symptom severity, and impact of UI symptoms on quality of life will be determined using standardized measures described above. Data analysis will define associations between changes in PERFECT measures and the change in UI episodes (based on 3-day voiding diary), severity, and type (based on QUID-7), and impact on quality of life (PFIQ-7) within and between groups. Objective measurement of lower-extremity strength will inform the relationship between lower-extremity strength, pelvic floor strength, and UI symptoms at baseline and the 6-week visit.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women, age 70 years or older
  • Diagnosis of Urinary Incontinence (defined by the QUID assessment as having subscale score for stress ≥4, and/or urge score ≥ 6)
  • Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
  • Willing and able to undergo an extensive physical function evaluation

Exclusion criteria

  • Prior surgical intervention for urinary incontinence within the past 12 months
  • Hysterectomy within 12 months
  • Diagnosis of:
  • Pelvic Organ Prolapse beyond the hymenal ring
  • Urogenital Fistula
  • Neurogenic Overactive Bladder (associated with a diagnosis of Multiple -Sclerosis or Stroke within past 12 months)
  • Incomplete Bladder Emptying/Urinary Retention with PVR >150 ml (measured by bladder scan)
  • Requires assisted device (4 point cane, walker) for ambulation all /most of the time or wheelchair bound
  • Having significant cognitive impairment or dementia
  • Unsafe to exercise (severe cardiopulmonary disease)
  • Unable/unwilling to provide informed consent
  • Determined otherwise ineligible by the principal investigator

Treatment and study plan

Pelvic floor muscle exercise

Behavioral

Standardized pelvic floor muscle exercise regimen

Primary outcomes

  1. Number of Urinary Incontinence Episodes

    Time frame: Baseline

    Using a three-day voiding diary

  2. Number of Urinary Incontinence Episodes

    Time frame: week 6

    Using a three-day voiding diary

  3. Number of Urinary Incontinence Episodes

    Time frame: week 12

    Using a three-day voiding diary

Secondary outcomes

  1. Power of Contractions

    Time frame: week 12

    measurement of strength using perineometer

  2. Endurance

    Time frame: week 12

    measure of how long they can hold contraction

  3. Repetition of Contractions

    Time frame: week 12

    how many repetitions can they sustain

  4. Number of Fast Contractions

    Time frame: week 12

    number of fast contractions that can be repeated

Other outcomes

  1. Pelvic Organ Prolapse

    Time frame: baseline, week 12

    measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system

  2. Short Physical Performance Battery (expSPPB)--Gait Speed

    Time frame: week 12

    expSPPB scores range from zero to 12 possible points. SPPB score of 0 indicates the lowest physical performance, and a score of 12 indicates the highest performance

  3. 400 Meter Walk

    Time frame: week 12

    measurement of exercise tolerance

  4. Isokinetic Dynamometer

    Time frame: week 12

    maximal isokinetic knee extensor strength in the right leg will be measured at speeds of 60 degrees/sec. The left leg will be used if there is a reason not to measure the right leg.

  5. Postural Sway

    Time frame: week 12

    Center-of-Pressure (COP) trajectory data will be collected using an Advanced Mechanical Incorporated (AMTI) AccuSway biomechanics force platform. Participants will be barefoot in an upright stance with arms raised comfortably at their sides, feet abducted, and heels separated. Four posturographic parameters (maximum antero-posterior and medio-lateral displacement, average sway velocity, and 95% confidence ellipse) and two statistical mechanics measures (stabilogram diffusion analysis and detrended fluctuation analysis) will be calculated to quantify postural sway according to our previously published methods.

  6. Grip Strength

    Time frame: week 12

    measure of weakness

  7. Gait Speed

    Time frame: week 12

    Determined based on 4-meter walk at usual speed

  8. Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Questionnaire

    Time frame: week 12

    The SARC-F questionnaire is validated to identify adults with sarcopenia and who are at risk for adverse outcomes and may benefit from a physical function intervention. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome.

  9. Appendicular Lean Muscle Mass/Height

    Time frame: week 12

    calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit

  10. Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire

    Time frame: week 12

    a brief valid measure that assesses weekly frequency and duration of various physical activities common to older adults to evaluate the efficacy of behavioral interventions to increase levels of physical activity. Caloric expenditure (MET hours/week) will be reported.[8] 'Low activity' will be defined as <6.2 MET-hours/week of activity. Women with MET hr/week between 6.3 and 11.4 will be classified as low-moderate activity. Since only 23% of incontinent women had >11.4 MET hours/week of physical activity, this level will be defined as high activity.

  11. Barriers to Physical Activity Questionnaire

    Time frame: week 12

    Questions regarding attitudes towards physical activity considering UI symptoms and perceived barriers will be assessed. 21-item measure assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63 with a higher score indicating a higher amount of perceived barriers.

  12. Mobility Assessment Tool-Short Form (MAT-SF) Score

    Time frame: week 12

    This tool shows self-reported mobility. The score range is 30-80 and a higher score denotes better self-reported mobility.

  13. Abdominal Circumference

    Time frame: week 12

    measure of abdominal circumference will be obtained to determine obesity severity

  14. Patient Global Impression of Improvement (PGI)

    Time frame: week 12

    The PGI is a single-item, 7-point scale used to assess a patient's overall perception of their condition's change after treatment. Originating from the Clinical Global Impression-Improvement (CGI-I) scale used by clinicians, the PGI-I allows patients to rate their progress from "Very Much Improved" to "Very Much Worse," providing a simple, validated, and patient-centered outcome measure for various medical and psychiatric conditions. Scores range from 1 (Very Much Improved) to 7 (Very Much Worse).

  15. Patient Satisfaction Question

    Time frame: week 12

    Participants are asked how satisfied they are with their progress in this program. Score ranges from 1 (Completely) to 3 (Not at all)

  16. Estimated Perception of Improvement Question

    Time frame: week 12

    Participants estimate how much better they are on a scale from 0% (no better) to 100% (completely better).

  17. Montreal Cognitive Assessment (MoCA)

    Time frame: week 12

    MoCA score ranges from 0 to 30 and is used as a screening tool for mild cognitive impairment. A score of 26 or over is considered to be normal.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Exploring the Role of Sarcopenia and Functional Impairment on the Non-Surgical Management of Urinary Incontinence in Older Women

Acronym: UNITS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2017
Registry last updated
Nov 10, 2025

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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