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

Urinary Incontinence, Urge Clinical Trial

— MOVEONUP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375344
• Other study ID #: 849788
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: May 2026

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: Uduak U Andy, MD
• Phone: (215) 662-7709
• Email: uduakumoh.andy[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Behavioral:
• Exercise Group
Home-based exercise group intervention

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of falls between the baseline visit and 1 year	number of falls reported in a falls diary	12 months
Secondary	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