Correlating Ic/Pbs Symptoms With Urine Biomarkers | NCT00817388

Studies
Correlating Ic/Pbs Symptoms With Urine Biomarkers

NCT00817388

Sponsor

Corewell Health East

Status

Completed

Last Update Posted

Jun 7, 2010Estimated

Enrollment

26Actual

Phase

Not provided

Conditions

Interstitial Cystitis
Pelvic Pain

Interventions

No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 5, 2009

First Submission Date that Met QC Criteria

Jan 5, 2009

First Posted Date

Jan 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2010

Last Update Posted Date

Jun 7, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		patients will be asked to provide a urine specimen and complete a questionnaire.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To correlate IC/PBS symptoms with urine biomarkers		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Chancellor, MD	Corewell Health East	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
William Beaumont Hospital		Royal Oak	Michigan	48073	United States

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided