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

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05375344
Collaborator
(none)
375
Enrollment
1
Location
2
Arms
46.7
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise Group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
375 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
MoVE on Up: Mobility and Voiding Exercises in Older Women With Urinary Incontinence
Actual Study Start Date :
Jun 9, 2022
Anticipated Primary Completion Date :
May 1, 2026
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Uduak Andy, Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05375344
Other Study ID Numbers:
  • 849788
First Posted:
May 16, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Urge

Study Results

No Results Posted as of Jul 25, 2022