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

University of Pennsylvania

Status: Active, not recruiting

Conditions: Urinary Incontinence, Urge

Treatments: Behavioral: Exercise Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05375344

849788

Details and patient eligibility

About

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.

Enrollment: 375 estimated patients

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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375 participants in 2 patient groups

Exercise Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise Group

Control Group

No Intervention group

Description:

Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence.