Sensory Processing in Subjects With Painful Bladder Syndrome

NCT ID: NCT00903643

Last Updated: 2014-07-22

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

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to determine if clinically relevant subsets exist in patients meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential responses to treatments and if verified, this will be important for the stratification of patients in clinical studies related to PBS.

Detailed Description

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Patients with the diagnosis of painful bladder syndrome (PBS) constitute two or more phenotypes that are distinguished by differential neurophysiological processing of sensory information. Further, these differing phenotypes can be predicted by the presence or absence of the co-morbidity fibromyalgia.

Conditions

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Painful Bladder Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy subjects

Physical examination

Intervention Type OTHER

Physical examination and multiple questionnaires will be administered

PBS subjects

Physical examination

Intervention Type OTHER

Physical examination and multiple questionnaires will be administered

Interventions

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Physical examination

Physical examination and multiple questionnaires will be administered

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* NIDDK criteria for Painful Bladder Syndrome
* Age 19 years or older
* Must be able to read and speak English since testing materials are validated in English

Exclusion Criteria

* PBS subjects must be independent of co-existing pain disorders or use of medications
* Uncontrolled hypertension or significant cardiopulmonary disease
* No chronic daily pain
* Older than 75 years of age
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University Early Recognition Center

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Ness, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Kirklin Clinic Urology Clinic

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F08047007

Identifier Type: -

Identifier Source: org_study_id

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