Examining Bladder Control Using Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI)
17 de agosto de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Real)
47
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Método de amostragem
Amostra Não Probabilística
População do estudo
Women seeking care at Oregon Health and Science University in Portland, Oregon.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Urge Incontinent Women
Women with documented urge/urgency incontinence with established care at the Oregon Health and Science University.
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Control Women
Women with no urge/urgency incontinence with established care at the Oregon Health and Science University.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Determine differences in fluctuations in brain activity between different regions of the brain associated with control functions.
Prazo: Once during up to 3 months
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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.
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Once during up to 3 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Scores on the Pelvic Floor Distress Inventory
Prazo: Once during up to 3 months
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This Questionnaire is a condition-specific quality of life questionnaire to assess pelvic floor disorders including urinary incontinence, pelvic organ prolapse and fecal incontinence.
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Once during up to 3 months
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3 Day Bladder Diary to Assess Participant Symptom Severity
Prazo: Once during up to 3 months
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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.
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Once during up to 3 months
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Determine any difference in brain response to bladder filling in subjects with and without overactive bladder.
Prazo: Once during up to 3 months
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Once during up to 3 months
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Determine functional brain connectivity with bladder.
Prazo: Once during up to 3 months
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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.
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Once during up to 3 months
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Scores on the Pelvic Floor Impact Questionnaire
Prazo: Once during up to 3 months
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This is another validated brief quality of life questionnaire to assess how various pelvic floor disorders affect specific daily activities.
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Once during up to 3 months
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Scores on the International Consultation on Incontinence Questionnaire
Prazo: Once during up to 3 months.
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This questionnaire allows assessment of the prevalence, frequency and perceived cause of urinary incontinence as well as its impact on life.
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Once during up to 3 months.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rahel Nardos, M.D., Oregon Health and Science University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2010
Conclusão Primária (Real)
22 de junho de 2012
Conclusão do estudo (Real)
22 de junho de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
16 de abril de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de abril de 2010
Primeira postagem (Estimativa)
26 de abril de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de agosto de 2017
Última verificação
1 de agosto de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- OHSU eIRB 6005
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