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

NCT01110278 | Completed

• 1 other identifier: OHSU eIRB 6005
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence, Urge

Keywords

Urge Urinary Incontinence; Magnetic Resonance Imaging; Diffusion Tensor Imaging; Brain Connectivity; Bladder Control; fMRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Scores on the Pelvic Floor Distress Inventory

  Once during up to 3 months

• 3 Day Bladder Diary to Assess Participant Symptom Severity

  Once during up to 3 months

• Determine any difference in brain response to bladder filling in subjects with and without overactive bladder.

  Once during up to 3 months

• Determine functional brain connectivity with bladder.

  Once during up to 3 months

• Scores on the Pelvic Floor Impact Questionnaire

  Once during up to 3 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Pfizer: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rahel Nardos, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 26, 2010
• Study Start: May 1, 2010
• Primary Completion: June 22, 2012
• Study Completion: June 22, 2012
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)