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Correlating Ic/Pbs Symptoms With Urine Biomarkers

Primary Purpose

Interstitial Cystitis, Pelvic Pain

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
No intervention
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Interstitial Cystitis focused on measuring Interstitial cystitis, pelvic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion:

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

Exclusion:

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

Sites / Locations

  • William Beaumont Hospital

Arms of the Study

Arm 1

Arm Type

Arm Label

1

Arm Description

patients will be asked to provide a urine specimen and complete a questionnaire.

Outcomes

Primary Outcome Measures

To correlate IC/PBS symptoms with urine biomarkers

Secondary Outcome Measures

Full Information

First Posted
January 5, 2009
Last Updated
June 4, 2010
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00817388
Brief Title
Correlating Ic/Pbs Symptoms With Urine Biomarkers
Official Title
Correlating Ic/Pbs Symptoms With Urine Biomarkers
Study Type
Observational

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Pelvic Pain
Keywords
Interstitial cystitis, pelvic pain

7. Study Design

Enrollment
26 (Actual)
Biospecimen Retention
Samples Without DNA
Biospecimen Description
Urine specimen.

8. Arms, Groups, and Interventions

Arm Title
1
Arm Description
patients will be asked to provide a urine specimen and complete a questionnaire.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
To correlate IC/PBS symptoms with urine biomarkers
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Study Population Description
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Chancellor, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

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Correlating Ic/Pbs Symptoms With Urine Biomarkers

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