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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rahel Nardos, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01110278
First received: April 16, 2010
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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.


Condition
Urinary Incontinence, Urge

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Examining the Brain's Control Systems in Normal and Overactive Bladder Using DTI and Functional MRI

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Scores on the Pelvic Floor Distress Inventory [ Time Frame: Once during up to 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Determine functional brain connectivity with bladder. [ Time Frame: Once during up to 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    This questionnaire allows assessment of the prevalence, frequency and perceived cause of urinary incontinence as well as its impact on life.


Enrollment: 47
Study Start Date: May 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women seeking care at Oregon Health and Science University in Portland, Oregon.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110278

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Pfizer
Investigators
Principal Investigator: Rahel Nardos, M.D. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Rahel Nardos, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01110278     History of Changes
Other Study ID Numbers: OHSU eIRB 6005
Study First Received: April 16, 2010
Last Updated: October 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Urge Urinary Incontinence
Magnetic Resonance Imaging
Diffusion Tensor Imaging
Brain Connectivity
Bladder Control
fMRI

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014