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Exercise for Urge Urinary Incontinence (MOVEONUP Trial)
N/A
Recruiting
Led By Uduak U Andy, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Living independently in the community
Not planning to initiate new UI or overactive bladder (OAB) treatment during the study duration
Must not have
Pelvic organ prolapse passed the hymen (per patient report)
Non-ambulatory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of a multi-dimensional falls prevention intervention versus informational booklets in reducing falls in older women with Urinary Urge Incontinence.
Who is the study for?
The MoVEonUp trial is for women aged 70 or older who live independently, can consent and communicate in English, are not very physically active, and have moderate to severe urge-predominant urinary incontinence. They should be able to participate in an exercise program without harming their health as confirmed by a doctor.
What is being tested?
This study tests if exercises that improve balance and strength combined with bladder training can reduce falls in older women with Urinary Urge Incontinence. Participants will either join the exercise group or receive educational booklets on fall prevention.
What are the potential side effects?
Since this trial involves physical exercises and behavioral techniques rather than medication, side effects may include muscle soreness or fatigue from the activities. Any other adverse effects would likely be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I live on my own and manage my daily activities.
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I am not planning to start new treatments for urinary issues during the study.
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I can walk on my own or with help from a device.
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I am 70 years old or older.
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I often feel a strong urge to urinate and sometimes can't control it.
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I am female.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a pelvic organ prolapse that extends beyond the vaginal opening.
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I cannot walk by myself.
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I have a worsening condition like Parkinson's or multiple sclerosis.
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I have not had a fracture or joint replacement in the last six months.
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I am currently receiving treatment for cancer, excluding non-melanoma skin cancer.
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I cannot communicate in English.
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I have had a stroke or fainting spells due to carotid sensitivity.
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I have vision or hearing problems that haven't been corrected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in number of falls between the baseline visit and 1 year
Secondary study objectives
Change in urinary incontinence score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline visit and 1 year
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Exercise GroupActive Control1 Intervention
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.
Group II: Control GroupActive Control1 Intervention
Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,673 Total Patients Enrolled
Uduak U Andy, MDPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart condition that is not stable according to your own report.I have a pelvic organ prolapse that extends beyond the vaginal opening.I live on my own and manage my daily activities.I am not planning to start new treatments for urinary issues during the study.I cannot walk by myself.I have urinary conditions or have had surgeries that could affect bladder control.I have a worsening condition like Parkinson's or multiple sclerosis.Your score on the ICIQ-SF questionnaire is less than 6.You have a significant problem with memory and thinking.I have not had a fracture or joint replacement in the last six months.I can walk on my own or with help from a device.You are able to join an exercise program without making any existing health issues worse, as decided by your doctor.I am currently receiving treatment for cancer, excluding non-melanoma skin cancer.You usually don't exercise for at least 30 minutes on most days of the week.I cannot communicate in English.I have had a stroke or fainting spells due to carotid sensitivity.I have vision or hearing problems that haven't been corrected.I am 70 years old or older.I often feel a strong urge to urinate and sometimes can't control it.You are willing to be randomly assigned to a study group.I am female.You understand the study and agree to participate by signing a consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.