Clinical trial NCT05375344: Mobility and Voiding Exercises in Older Women with Urinary Incontinence (MoVEonUp)
Official title: MoVE on Up: Mobility and Voiding Exercises in Older Women with Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence, Urge
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 375
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in number of falls between the baseline visit and 1 year
timeFrame: 12 months
Secondary outcomes:
measure: Change in urinary incontinence score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline visit and 1 year
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Uduak U Andy, MD
role: PRINCIPAL_INVESTIGATOR
References: