Sensory Processing in Subjects With Painful Bladder Syndrome

This study has been completed.
Sponsor:
Collaborator:
Washington University Early Recognition Center
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00903643
First received: May 14, 2009
Last updated: July 19, 2014
Last verified: July 2014
  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 ]

Enrollment: 34
Study Start Date: May 2008
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: July 19, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014