Correlating Ic/Pbs Symptoms With Urine Biomarkers - Full Text View

Sponsored by:	William Beaumont Hospitals
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00817388

Purpose

Completion of a brief survey tool and providing an urine specimen. The study purpose is to improve our understanding of interstitial cystitis and painful pelvic syndrome.

Condition	Intervention
Interstitial Cystitis Pelvic Syndrome	Other: No intervention

MedlinePlus related topics: Interstitial Cystitis Urine and Urination

U.S. FDA Resources

Study Type:	Observational
Official Title:	Correlating Ic/Pbs Symptoms With Urine Biomarkers

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

To correlate IC/PBS symptoms with urine biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Urine specimen.

Estimated Enrollment:	500
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 patients will be asked to provide a urine specimen and complete a questionnaire.	Other: No intervention No intervention

Detailed Description:

The purpose of the study is to improve our understanding of the IC/PBS and develop new treatments. Participation in the study will allow us to compare clinical information, obtained by completion of a brief survey, with substances found in the a urine specimen that is donated to the Beaumont Biobank.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients with and without intersitial cystitis/painful pelvic pain will be asked to provide an urine specimen and complete a brief questionnaire.

Criteria

Inclusion:

Men and women with interstitial cystitis/painful bladder syndrome greater than 18 years old
Male and female controls without a history of IC/PBS diagnosis

Exclusion:

1. Unable to complete questionnaires and/or give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817388

Locations

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Principal Investigator:

Michael Chancellor, MD

William Beaumont Hospitals

More Information

Responsible Party:	Beaumont Hospitals ( Michael Chancellor, MD )
Study ID Numbers:	2008-294
Study First Received:	January 5, 2009
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00817388
Health Authority:	United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:

Interstitial cystitis
painful pelvic pain

Study placed in the following topic categories:

Cystitis, Interstitial
Cystocele
Pelvic Pain
Urologic Diseases

Urinary Bladder Diseases
Cystitis
Pain

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 13, 2009