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NCT00903643 Clinical Trial

Sensory Processing in Subjects With Painful Bladder Syndrome

Painful Bladder Syndrome Clinical Trial

Official title:
Sensory Processing in Subjects With Painful Bladder Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00903643
Other study ID # F08047007
Secondary ID
Status Completed
Phase N/A
First received May 14, 2009
Last updated July 19, 2014
Start date May 2008
Est. completion date June 2014

Study information
Verified date July 2014
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Physical examination
Physical examination and multiple questionnaires will be administered

Locations
Country Name City State
United States Kirklin Clinic Urology Clinic Birmingham Alabama

Sponsors (2)
Lead Sponsor Collaborator
University of Alabama at Birmingham Washington University Early Recognition Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. One and half to two hours. No
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