Urinary Incontinence, Urge
Conditions
Brief summary
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.
Interventions
BEHAVIORALExercise Group
Home-based exercise group intervention
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
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 the study PI or designee
Exclusion criteria
* 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) * Per PI discretion, participant cannot enroll in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of falls between the baseline visit and 1 year | 12 months | number of falls reported in a falls diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary incontinence score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline visit and 1 year | 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORUduak U Andy, MD
University of Pennsylvania
Outcome results
None listed