Sensory Sensitivity and Urinary Symptoms in the Female Population

NCT ID: NCT01978002

Last Updated: 2016-04-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Brief Summary

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Bladder pain and discomfort, as well as urinary urgency and frequency, are bothersome symptoms seen frequently in the general population. Clinical diagnostic terms used to describe these symptoms include interstitial cystitis (IC), bladder pain syndrome (BPS), chronic prostatitis, and overactive bladder (OAB), but there is tremendous overlap between these entities, and the distinction between them is based more on eminence than evidence.

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.

Detailed Description

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Conditions

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Bladder Pain and Discomfort Urinary Urgency and Frequency Bothersome Symptoms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 (Clinic Patients)

Women who have documented urinary status from surveys completed.

Pain sensitivity testing

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Urodynamic testing

Intervention Type BEHAVIORAL

Interventions

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Pain sensitivity testing

Intervention Type BEHAVIORAL

Urodynamic testing

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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James Clemens

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00054279

Identifier Type: -

Identifier Source: org_study_id

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