Examining Bladder Control Using Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI)
|ClinicalTrials.gov Identifier: NCT01110278|
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : August 22, 2017
|Condition or disease|
|Urinary Incontinence, Urge|
|Study Type :||Observational|
|Actual Enrollment :||47 participants|
|Official Title:||Examining the Brain's Control Systems in Normal and Overactive Bladder Using DTI and Functional MRI|
|Study Start Date :||May 2010|
|Primary Completion Date :||June 22, 2012|
|Study Completion Date :||June 22, 2012|
Urge Incontinent Women
Women with documented urge/urgency incontinence with established care at the Oregon Health and Science University.
Women with no urge/urgency incontinence with established care at the Oregon Health and Science University.
- 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.
- 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.
- 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.
- Determine any difference in brain response to bladder filling in subjects with and without overactive bladder. [ Time Frame: 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110278
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Rahel Nardos, M.D.||Oregon Health and Science University|