Urinary Incontinence, UrgeNCT01110278
Examining Bladder Control Using Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI)
An observational study of Urinary Incontinence, Urge, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Urge
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 22 Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women seeking care at Oregon Health and Science University in Portland, Oregon.
Who may be able to join
- 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.
- Female gynecology patients between age 40 and 85.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Examining the Brain's Control Systems in Normal and Overactive Bladder Using DTI and Functional MRI
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.
Read the 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.
- Conditions
- Urinary Incontinence, Urge
- Keywords
- Urge Urinary Incontinence, Magnetic Resonance Imaging, Diffusion Tensor Imaging, Brain Connectivity, Bladder Control, fMRI
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once during up to 3 months
Secondary outcomes (6)
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.
Measured: Once during up to 3 months
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.
Measured: Once during up to 3 months
Determine any difference in brain response to bladder filling in subjects with and without overactive bladder.
Measured: Once during up to 3 months
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.
Measured: Once during up to 3 months
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.
Measured: Once during up to 3 months
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.
Measured: Once during up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMay 2010
- Primary completion22 Jun 2012
- Study completion22 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, UrgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Rahel Nardos, Oregon Health and Science University
- Investigators
- Rahel Nardos, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110278
- Sponsor's protocol ID
- OHSU eIRB 6005
- Status last verified
- Aug 2017
- First submitted
- 16 Apr 2010
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Brain's Control Systems in Normal and Overactive Bladder Using DTI and Functional MRI
- ClinicalTrials.gov ID
- NCT01110278
- Acronym / sponsor ID
- OHSU eIRB 6005
- Conditions
- Urinary Incontinence, Urge
- Keywords
- Urge Urinary Incontinence, Magnetic Resonance Imaging, Diffusion Tensor Imaging, Brain Connectivity, Bladder Control, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2010
- Primary completion
- 22 Jun 2012 (actual)
- Study completion
- 22 Jun 2012 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women seeking care at Oregon Health and Science University in Portland, Oregon.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Scores on the Pelvic Floor Distress Inventory
Time frame: Once during up to 3 months
3 Day Bladder Diary to Assess Participant Symptom Severity
Time frame: 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
Determine functional brain connectivity with bladder.
Time frame: Once during up to 3 months
Scores on the Pelvic Floor Impact Questionnaire
Time frame: Once during up to 3 months
Scores on the International Consultation on Incontinence Questionnaire
Time frame: Once during up to 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahel Nardos, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, Urge, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.