- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01110278
Examining Bladder Control Using Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI)
Examining the Brain's Control Systems in Normal and Overactive Bladder Using DTI and Functional MRI
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
CASE GROUP: This group will include 15 patients presenting to the urogynecology clinic at OHSU with current bladder overactivity symptoms including urgency and urgency incontinence with documented detrusor overactivity on multichannel urodynamic assessment.
Inclusion criteria:
- Female urogynecology patients between age 40 and 85.
- Without a history of incontinence surgery
- Have current overactive bladder symptoms including urgency and urgency incontinence daily for the previous three months (must answer "about once a day to Question A1:how often do you leak urine, on initial screening questionnaire, and "3 or more months to question A2: How long have you experienced accidental leakage, and "yes" to question A3:Do you usually experience urinary leakage associated with feeling of urgency).
- Documented detrusor overactivity by urodynamic study within 3 months of the study is required.
- Patients who have a history of past anticholinergic therapy will be included as long as they have been off medication for 2 weeks prior to imaging.
Exclusion criteria:
- Medical contraindications for MRI scanning.
- Past or present overt neurological disease such as history of stroke, epilepsy, MS, spinal cord injury.
- History of pelvic irradiation or bladder cancer.
- Current urinary tract infection.
- Current pelvic pain disorder.
CONTROL GROUP: This group will include 25 gynecology patients without a history of any urinary incontinence symptoms.
Inclusion Criteria:
- Female gynecology patients between age 40 and 85.
- Without a history of urinary incontinence (must answer "never" to question A1: how often do you leak urine, on initial screening questionnaire).
- Without a history of incontinence surgery.
- Without a history of overactive bladder.
- Without pelvic pain.
- Without irritative bladder symptoms (must say "no" to question A4: do you experience frequent urination on initial screening questionnaire).
Exclusion criteria:
- Medical contraindications for MRI scanning.
- Past or present overt neurological disease such as history of stroke, epilepsy, MS, spinal cord injury.
- History of pelvic irradiation or bladder cancer.
- Current urinary tract infection.
- Current pelvic pain disorder.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Urge Incontinent Women
Women with documented urge/urgency incontinence with established care at the Oregon Health and Science University.
|
Control Women
Women with no urge/urgency incontinence with established care at the Oregon Health and Science University.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine differences in fluctuations in brain activity between different regions of the brain associated with control functions.
Time Frame: Once during up to 3 months
|
We will look at the overall group differences to see if there are differences between the case group participants and control group participants in control brain regions related to normal bladder function.
|
Once during up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scores on the Pelvic Floor Distress Inventory
Time Frame: Once during up to 3 months
|
This Questionnaire is a condition-specific quality of life questionnaire to assess pelvic floor disorders including urinary incontinence, pelvic organ prolapse and fecal incontinence.
|
Once during up to 3 months
|
3 Day Bladder Diary to Assess Participant Symptom Severity
Time Frame: Once during up to 3 months
|
Subjects will be given three questionnaires and will also be asked to keep a diary that tracks their bladder and urinary habits for 3 days.
|
Once during up to 3 months
|
Determine any difference in brain response to bladder filling in subjects with and without overactive bladder.
Time Frame: Once during up to 3 months
|
Once during up to 3 months
|
|
Determine functional brain connectivity with bladder.
Time Frame: Once during up to 3 months
|
In order to asses functional connectivity (measurement of the strength of integration between brain regions), direct statistical comparison of connectivity maps derived from urge incontinence versus control groups will be done.
|
Once during up to 3 months
|
Scores on the Pelvic Floor Impact Questionnaire
Time Frame: Once during up to 3 months
|
This is another validated brief quality of life questionnaire to assess how various pelvic floor disorders affect specific daily activities.
|
Once during up to 3 months
|
Scores on the International Consultation on Incontinence Questionnaire
Time Frame: Once during up to 3 months.
|
This questionnaire allows assessment of the prevalence, frequency and perceived cause of urinary incontinence as well as its impact on life.
|
Once during up to 3 months.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rahel Nardos, M.D., Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHSU eIRB 6005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence, Urge
-
TriHealth Inc.TerminatedUrinary Urge IncontinenceUnited States
-
Duke UniversitySociety of Urodynamics and Female Pelvic Medicine & Urogenital ReconstructionTerminatedUrinary Urge IncontinenceUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
Elidah, Inc.RecruitingUrge IncontinenceUnited States
-
Klinikum der Universität KölnUnknownSurgical Treatment of Urge IncontinenceGermany
-
University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
Prof. Dr. Volker ViereckCompletedMixed Incontinence, Urge and StressSwitzerland
-
Stamford HospitalWithdrawnOveractive Bladder | Urge Incontinence | Urinary UrgeUnited States
-
Valencia Technologies CorporationCompletedOveractive Bladder | Urge Incontinence | Urinary Urge Incontinence | Incontinence, UrinaryUnited States, New Zealand
-
Kasr El Aini HospitalUnknownFemales With Overactive Bladder Symptoms, Urgency & Urge Incontinence