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

Not Applicable

Recruiting

• Conditions: Urinary Incontinence, Urge
• Interventions: Behavioral: Exercise Group

• Registration Number: NCT05375344
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Study Start: 2022-06-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 375

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Exercise Group	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.

Primary Outcome Measures

Name	Time	Method
Change in number of falls between the baseline visit and 1 year	12 months	number of falls reported in a falls diary

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States