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Functional MRI for Urinary Incontinence
N/A
Recruiting
Led By Becky Clarkson, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Other comorbidities: uncontrolled depression (PHQ-9 ≥10)
Current or prior treatment for UUI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes of 1 hour mri scan
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the brain control of the bladder in young, old, and incontinent people to help understand how urinary incontinence develops and suggest new treatments.
Who is the study for?
This trial is for women aged 18-45 or 65+ with urge urinary incontinence (UUI) more than five times a week, despite treatment. It's also for continent women without UUI. Participants must be able to differentiate between UUI and stress incontinence, have no major health issues affecting mobility or requiring upcoming surgery, and be MRI compatible.
What is being tested?
The study uses brain functional MRI alongside simplified urodynamics to understand how the brain controls the bladder in young vs old individuals and those with vs without urinary incontinence. The goal is to identify changes due to aging or disease.
What are the potential side effects?
Since this trial involves non-invasive imaging techniques like functional MRI, side effects are minimal but may include discomfort from lying still during the scan and potential anxiety or claustrophobia inside the MRI machine.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe depression.
Select...
I have been treated for urinary urgency incontinence.
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I have a neurological condition like MS, Parkinson's, or have had a stroke.
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It takes me 12 seconds or longer to stand up, walk a short distance, and sit down again.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minutes of 1 hour mri scan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes of 1 hour mri scan
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
BOLD (Blood oxygen level dependent) fMRI signal contrast
Secondary study objectives
Changes in brain structural integrity
Differences in volume of brain structures
Differences in white matter damage of brain structures
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Brain functional MRI with simplified urodynamicsExperimental Treatment1 Intervention
Females with urgency urinary incontinence
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,787 Previous Clinical Trials
16,359,163 Total Patients Enrolled
11 Trials studying Urinary Incontinence
3,212 Patients Enrolled for Urinary Incontinence
National Institute on Aging (NIA)NIH
1,785 Previous Clinical Trials
28,184,546 Total Patients Enrolled
13 Trials studying Urinary Incontinence
2,450 Patients Enrolled for Urinary Incontinence
Becky Clarkson, PhDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
404 Total Patients Enrolled
3 Trials studying Urinary Incontinence
404 Patients Enrolled for Urinary Incontinence
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe depression.You have metal implants that are not safe for MRI, or you are claustrophobic and cannot be in a small, closed space for the MRI.You have trouble with memory and thinking, have difficulty keeping track of medication, or are unable to follow instructions for certain tests.I do not have severe high blood pressure, upcoming major medical changes, or frailty.I have been treated for urinary urgency incontinence.I have a neurological condition like MS, Parkinson's, or have had a stroke.I am willing to stop my anticholinergic/beta-3 agonist medications for 4 weeks.Your bladder diary shows leaks that are not due to a small amount of stress urinary incontinence.I am not allergic to the study medication, and it doesn't interact with my current medications.I am a woman over 65 or between 18-45, mentally and physically able.It takes me 12 seconds or longer to stand up, walk a short distance, and sit down again.I can tell the difference between leakage when I cough or move and when I suddenly need to urinate.I have a history of specific urinary or pelvic conditions or treatments.I experience sudden urges to urinate that I can't control more than 5 times a week or I don't have this issue.I'm not sure what "Dry Groups" refers to in this context. Can you provide more details or clarify the term?
Research Study Groups:
This trial has the following groups:- Group 1: Brain functional MRI with simplified urodynamics
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.
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