Sensory Processing in Subjects With Painful Bladder Syndrome

NCT00903643 | Completed DMC

• 1 other identifier: F08047007
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Bladder Syndrome

Keywords

Painful Bladder Syndrome; Urinary Bladder

Outcome Measures

Primary Outcomes (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.

  One and half to two hours.

Study Arms (2)

Healthy subjects

Other: Physical examination

PBS subjects

Other: Physical examination

Interventions

Physical examination OTHER

Physical examination and multiple questionnaires will be administered

Healthy subjects; PBS subjects

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Washington University Early Recognition Center: collaborator

Study Sites (1)

Kirklin Clinic Urology Clinic

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Timothy Ness, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: May 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

US (1)