Examining Bladder Control Using Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI)
17 sierpnia 2017 zaktualizowane przez: Rahel Nardos, Oregon Health and Science University
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.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
47
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Oregon
-
Portland, Oregon, Stany Zjednoczone, 97239
- Oregon Health & Science University
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
40 lat do 85 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Kobieta
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Women seeking care at Oregon Health and Science University in Portland, Oregon.
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Determine differences in fluctuations in brain activity between different regions of the brain associated with control functions.
Ramy czasowe: 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.
|
Once during up to 3 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Scores on the Pelvic Floor Distress Inventory
Ramy czasowe: 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.
|
Once during up to 3 months
|
|
3 Day Bladder Diary to Assess Participant Symptom Severity
Ramy czasowe: 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.
|
Once during up to 3 months
|
|
Determine any difference in brain response to bladder filling in subjects with and without overactive bladder.
Ramy czasowe: Once during up to 3 months
|
Once during up to 3 months
|
|
|
Determine functional brain connectivity with bladder.
Ramy czasowe: 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.
|
Once during up to 3 months
|
|
Scores on the Pelvic Floor Impact Questionnaire
Ramy czasowe: 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.
|
Once during up to 3 months
|
|
Scores on the International Consultation on Incontinence Questionnaire
Ramy czasowe: 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.
|
Once during up to 3 months.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Rahel Nardos, M.D., Oregon Health and Science University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 maja 2010
Zakończenie podstawowe (Rzeczywisty)
22 czerwca 2012
Ukończenie studiów (Rzeczywisty)
22 czerwca 2012
Daty rejestracji na studia
Pierwszy przesłany
16 kwietnia 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 kwietnia 2010
Pierwszy wysłany (Oszacować)
26 kwietnia 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 sierpnia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 sierpnia 2017
Ostatnia weryfikacja
1 sierpnia 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- OHSU eIRB 6005
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .