Sensory Processing in Subjects With Painful Bladder Syndrome
This study is currently recruiting participants.
Verified March 2013 by University of Alabama at Birmingham
Sponsor:
University of Alabama at Birmingham
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00903643
First received: May 14, 2009
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
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 | Intervention |
|---|---|
|
Painful Bladder Syndrome |
Other: Physical examination |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Sensory Processing in Subjects With Painful Bladder Syndrome |
Further study details as provided by University of Alabama at Birmingham:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903643
Contacts
| Contact: Timothy J Ness, MD, PhD | 205-934-4665 | tjness@uab.edu |
Locations
| United States, Alabama | |
| Kirklin Clinic Urology Clinic | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Timothy J Ness, MD, PhD 205-934-6501 tjness@uab.edu | |
| Sub-Investigator: Laurence Bradley, PhD | |
| Sub-Investigator: Georg Deutsch, PhD | |
| Sub-Investigator: L. Keith Lloyd, MD | |
Sponsors and Collaborators
University of Alabama at Birmingham
Washington University School of Medicine
Investigators
| Principal Investigator: | Timothy Ness, MD, PhD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00903643 History of Changes |
| Other Study ID Numbers: | F08047007 |
| Study First Received: | May 14, 2009 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
Painful Bladder Syndrome Urinary Bladder |
Additional relevant MeSH terms:
|
Pain Cystitis, Interstitial Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Cystitis Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013