Sensory Processing in Subjects With Painful Bladder Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Painful Bladder Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Kirklin Clinic Urology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Washington University Early Recognition Center
• Investigators: Principal Investigator: Timothy Ness, MD, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 14, 2009
• First Submitted That Met QC Criteria: May 15, 2009
• First Posted (Estimate): May 18, 2009

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: July 19, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Painful Bladder Syndrome; Urinary Bladder
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Disease; Cystitis; Syndrome; Pain; Cystitis, Interstitial
• Other Study ID Numbers: F08047007