Examining Bladder Control Using Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI)

Urinary Incontinence, Urge Clinical Trial

Official title:

Examining the Brain's Control Systems in Normal and Overactive Bladder Using DTI and Functional MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110278
• Other study ID #: OHSU eIRB 6005
• Status: Completed
• Phase: N/A
• First received: April 16, 2010
• Last updated: August 17, 2017
• Start date: May 2010
• Est. completion date: June 22, 2012

Study information

• Verified date: August 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Urgency incontinence (where the bladder muscles contract suddenly, causing an immediate urge to urinate that is difficult to prevent) is commonly experienced in patients with overactive bladder. New findings have discovered that urgency incontinence may be connected to the interactions of certain regions of the brain and the bladder. Although this is a common problem, researchers still do not know how these interactions impact the process of urgency incontinence. The purpose of this study is to better understand how the brain functions, by using Magnetic Resonance Imaging (MRI) machine and Diffusion Tensor Imaging (DTI) to create images of the brain during different bladder states.

Description:

One devastating manifestation of overactive bladder is urgency incontinence. Although urgency incontinence is a common problem with profound clinical, social and psychological consequences, little is understood about its underlying cause. The involuntary detrusor overactivity (DO) often associated with the disease points to a possible abnormality in voluntary control of the spinobulbospinal voiding reflex by a higher order neuronal network. Recent functional MRI (fMRI) and PET studies have identified increased brain activity during bladder filling and voiding in normal subjects from higher order cognitive control centers. In addition, there are now data to suggest that interactions between these brain areas, which include the pontine micturition center (PMC), periaqueductal gray (PAG), thalamus, insula, dorsal anterior cingulate and prefrontal cortex, may be abnormal in patients with urgency incontinence. Despite these encouraging findings, we do not yet know how these regions are interacting with each other, or to other, unknown but important, regions in the brain. Nor do we know how this interaction might play a role in this disease process. Expanding our knowledge of how these regions are integrated to achieve continence and, importantly, what aspects of this complex circuitry are atypical in patients with urge incontinence is key to our future therapeutic endeavors. With this in mind, the goal of this study is to better characterize the functional integration (i.e. functional connectivity) of the brain's control networks in relation to typical and atypical bladder function. We aim to identify distinct differences in the brain's functional and anatomic topography in women with and without urgency incontinence. Our approach not only has the potential to advance our understanding of the higher level pathophysiology of this disease process, but could also lead to novel more centrally acting therapeutic approaches for treatment of urgency incontinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 22, 2012
• Est. primary completion date: June 22, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Urge

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine differences in fluctuations in brain activity between different regions of the brain associated with control functions.	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	Scores on the Pelvic Floor Distress Inventory	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
Secondary	3 Day Bladder Diary to Assess Participant Symptom Severity	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
Secondary	Determine any difference in brain response to bladder filling in subjects with and without overactive bladder.		Once during up to 3 months
Secondary	Determine functional brain connectivity with bladder.	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
Secondary	Scores on the Pelvic Floor Impact Questionnaire	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
Secondary	Scores on the International Consultation on Incontinence Questionnaire	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.