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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence, Urge
• Intervention / Treatment: Behavioral: Exercise Group

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia Vresilovic; Email: julia.vresilovic@pennmedicine.upenn.edu
• Study Contact Backup: Name: Uduak U Andy, MD; Phone Number: (215) 662-7709; Email: uduakumoh.andy@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Uduak Andy, MD; Email: UduakUmoh.Andy@pennmedicine.upenn.edu
      • Contact: Lisa Borodyanskaya; Email: Yelizaveta.Borodyanskaya@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Exercise Group; Home-based exercise group intervention
No Intervention: Control Group; Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of falls between the baseline visit and 1 year	number of falls reported in a falls diary	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Uduak U Andy, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
• Other Study ID Numbers: 849788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No