Mobility and Voiding Exercises in Older Women With Urinary Incontinence (MoVEonUp) (MOVEONUP)
Primary Purpose
Urinary Incontinence, Urge
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Group
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Urge
Eligibility Criteria
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
Sites / Locations
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Exercise Group
Control Group
Arm 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.
Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence.
Outcomes
Primary Outcome Measures
Change in number of falls between the baseline visit and 1 year
number of falls reported in a falls diary
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05375344
First Posted
May 10, 2022
Last Updated
August 2, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT05375344
Brief Title
Mobility and Voiding Exercises in Older Women With Urinary Incontinence (MoVEonUp)
Acronym
MOVEONUP
Official Title
MoVE on Up: Mobility and Voiding Exercises in Older Women With Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Group
Intervention Description
Home-based exercise group intervention
Primary Outcome Measure Information:
Title
Change in number of falls between the baseline visit and 1 year
Description
number of falls reported in a falls diary
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in urinary incontinence score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline visit and 1 year
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uduak U Andy, MD
Phone
(215) 662-7709
Email
uduakumoh.andy@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Vresilovic
Email
julia.vresilovic@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uduak U Andy, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uduak Andy, MD
Email
UduakUmoh.Andy@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Lisa Borodyanskaya
Email
Yelizaveta.Borodyanskaya@pennmedicine.upenn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobility and Voiding Exercises in Older Women With Urinary Incontinence (MoVEonUp)
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