Sensory Sensitivity and Urinary Symptoms in the Female Population
NCT ID: NCT01978002
Last Updated: 2016-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2011-11-30
Brief Summary
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Pain and/or sensory sensitivity has been suspected to play a role in the pathogenesis of both bladder pain and urinary urgency/frequency. However, no previous studies have investigated whether entities such as IC/BPS and OAB might merely represent different points in a continuum of bladder sensory sensitivity. Moreover, we know of no studies that have directly compared sensory sensitivity in the bladder to global (i.e. CNS-mediated) sensory sensitivity.
In the study, a team of investigators with complementary expertise will perform a population-based study assessing bladder and overall sensory sensitivity, in a cohort of women representative of the population with respect to the entire continuum of bladder pain (from none to severe), and symptoms of urgency/frequency. These individuals will undergo urodynamics to measure sensory sensitivity in the bladder, as well as pressure pain and auditory loudness thresholds. The Specific Aims are to demonstrate: 1) sensory sensitivity in the bladder is related to sensory sensitivity elsewhere in the body, suggesting a CNS-driven mechanism, and 2) individuals in the population with greater global sensory sensitivity will display: a) more bladder pain, b) more urgency/frequency, and c) other symptoms of centrally-mediated pain states, such as pain in regions other than the bladder, fatigue, and insomnia.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1 (Clinic Patients)
Women who have documented urinary status from surveys completed.
Pain sensitivity testing
Group 2 (Community Sample)
Women who have a clinical diagnosis of IC/BPS or OAB, and who have undergone urodynamic testing within the preceding 6 months as part of their routine clinical care.
Pain sensitivity testing
Urodynamic testing
Interventions
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Pain sensitivity testing
Urodynamic testing
Eligibility Criteria
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Inclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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James Clemens
Principal Investigator
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00054279
Identifier Type: -
Identifier Source: org_study_id
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