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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 5, 2009 | ||||
| Last Updated Date | January 5, 2009 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To correlate IC/PBS symptoms with urine biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Correlating Ic/Pbs Symptoms With Urine Biomarkers | ||||
| Official Title ICMJE | Correlating Ic/Pbs Symptoms With Urine Biomarkers | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Other, Other | ||||
| Condition ICMJE |
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| Intervention ICMJE | Other: No intervention | ||||
| Study Arms / Comparison Groups | patients will be asked to provide a urine specimen and complete a questionnaire. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion:
Exclusion: 1. Unable to complete questionnaires and/or give informed consent |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00817388 | ||||
| Responsible Party | Michael Chancellor, MD, Beaumont Hospitals | ||||
| Study ID Numbers ICMJE | 2008-294 | ||||
| Study Sponsor ICMJE | William Beaumont Hospitals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | William Beaumont Hospitals | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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