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

17 agosto 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

47

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Oregon Health & Science University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Determine differences in fluctuations in brain activity between different regions of the brain associated with control functions.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Scores on the Pelvic Floor Distress Inventory
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: Once during up to 3 months
Once during up to 3 months
Determine functional brain connectivity with bladder.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Oregon Health and Science University

Collaboratori

Pfizer

Investigatori

  • Investigatore principale: Rahel Nardos, M.D., Oregon Health and Science University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2010

Completamento primario (Effettivo)

22 giugno 2012

Completamento dello studio (Effettivo)

22 giugno 2012

Date di iscrizione allo studio

Primo inviato

16 aprile 2010

Primo inviato che soddisfa i criteri di controllo qualità

23 aprile 2010

Primo Inserito (Stima)

26 aprile 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 agosto 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 agosto 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • OHSU eIRB 6005

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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