Mobility and Voiding Exercises in Older Women With Urinary Incontinence (MoVEonUp)

Study Overview
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Brief Summary
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A prospective, two-arm randomized clinical trial utilizing a multidimensional intervention to reduce falls in older women with Urinary Urge Incontinence. The intervention consist of general balance and strength training, bladder training and urge suppression, and home hazard assessments. The control group will receive informational booklets on fall prevention and behavioral treatment for urinary urge incontinence.

Official Title
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MoVE on Up: Mobility and Voiding Exercises in Older Women With Urinary Incontinence

Conditions
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Urinary Incontinence, Urge

Intervention / Treatment
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* Behavioral: Exercise Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 70 or older Living independently in the community Willingness to be randomized. Ability to read and understand English Be able to provide informed consent Low physical activity (physically active for 30 minutes or more less than or equal to 2 days per week on average over the past 6 months) per PAS Ambulatory (defined as patient not confined to bed or wheelchair OR ability to walk with or without an assistive device) Self-reported moderate to severe urge-predominant UI based on the ICIQ-SF > 6 (Q 1+2+3) Not planning to initiate new UI or overactive bladder (OAB) treatment during the study duration Capable of participation in an exercise program without exacerbating any pre-existing condition(s), as determined by their personal physician Exclusion Criteria: Unable to communicate in English Non-ambulatory Pelvic organ prolapse passed the hymen (per patient report) Undergoing active treatment for cancer (other than non-melanoma skin cancer) Uncorrected visual or hearing loss. Other urinary conditions or procedures that may affect continence status for example: urethral diverticulum, previous augmentation cystoplasty Progressive neurodegenerative disease e.g. Parkinson's disease, multiple sclerosis per patient report History of stroke or carotid sensitivity (i.e. syncopal falls) per patient report Unstable cardiac disease per patient report Fracture or joint replacement within the last six months per patient report Significant cognitive impairment (defined as a modified TICs score of < 27) Not willing to sign Consent Form ICIQ-SF < 6 (Q 1+2+3) Primary care provider says no to enrollment

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Group<br>Participants in this group will participate in the home-based exercise group intervention that consists of general balance and strength training, bladder training and urge suppression, and home hazard assessments. | Behavioral: Exercise Group<br>* Home-based exercise group intervention<br>|
| No Intervention: Control Group<br>Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of falls between the baseline visit and 1 year | number of falls reported in a falls diary | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary incontinence score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline visit and 1 year | Change in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). A minimum score is 0, a maximum score is 21 with a higher score indicating higher severity. | 12 months |