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Sensory Processing in Subjects With Painful Bladder Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00903643
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Painful Bladder Syndrome Other: Physical examination

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sensory Processing in Subjects With Painful Bladder Syndrome
Study Start Date : May 2008
Primary Completion Date : June 2014
Study Completion Date : June 2014
Groups and Cohorts

Group/Cohort Intervention/treatment
Healthy subjects Other: Physical examination
Physical examination and multiple questionnaires will be administered
PBS subjects Other: Physical examination
Physical examination and multiple questionnaires will be administered


Outcome Measures

Primary Outcome Measures :
  1. This study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on muscles and by applying a blood pressure cuff. [ Time Frame: One and half to two hours. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with condition will be from Kirklin Clinic Urology Clinic and the Highlands Pain Treatment Clinic. Healthy subjects will be recruited via advertisements.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903643


Locations
United States, Alabama
Kirklin Clinic Urology Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Washington University Early Recognition Center
Investigators
Principal Investigator: Timothy Ness, MD, PhD University of Alabama at Birmingham
More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00903643     History of Changes
Other Study ID Numbers: F08047007
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Keywords provided by University of Alabama at Birmingham:
Painful Bladder Syndrome
Urinary Bladder

Additional relevant MeSH terms:
Syndrome
Pain
Cystitis, Interstitial
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cystitis
Urinary Bladder Diseases
Urologic Diseases