Impact Of Sacral Neuromodulation On Urine Markers For Interstitial Cystitis (IC) - Full Text View

Sponsored by:	William Beaumont Hospitals
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00704457

Purpose

Urine will be collected and sent to the University of Maryland. Urines will be analyzed for urine markers.

Condition
Interstitial Cystitis

MedlinePlus related topics: Interstitial Cystitis Urine and Urination

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Impact Of Sacral Neuromodulation On Urine Markers For IC

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

The purpose of this study is measure urine levels of APF, HBEGF and EGF in patients with interstitial cystitis who have elected to undergo sacral nerve stimulation as a treatment modality for their disease. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Urines were collected and sent for urine marker analysis.

Enrollment:	11
Study Start Date:	February 2004
Study Completion Date:	December 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts
A One arm study. Urine collection.

Detailed Description:

Urine will be collected and flash frozen in liquid nitrogen then placed in a -70 C freezer. All urine will be collected and stored until the final follow-up is complete. The urine samples will then be sent as a single batch to the Department of Infectious Disease, University of Maryland. Urines will be assayed in a blinded fashion and a written report of the levels of each of the 3 urine markers will be sent to Beaumont Hospital. Change in urine marker levels will be analyzed and correlated with change in symptom scores.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who have undergone sacral nerve stimulation.

Criteria

Inclusion Criteria:

Patients will be drawn from Dr. Peters patient base that covers SE Michigan.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704457

Locations

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

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Principal Investigator:

Kenneth Peters, MD

William Beaumont Hospitals

More Information

Responsible Party:	William Beaumont Hospital ( Kenneth Peters, Md )
Study ID Numbers:	HIC 2004-024
Study First Received:	June 24, 2008
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00704457
Health Authority:	United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:

Interstitial Cystitis
IC
Sacral Nerve Stimulation

Study placed in the following topic categories:

Cystitis, Interstitial
Cystocele
Urologic Diseases
Urinary Bladder Diseases
Cystitis

ClinicalTrials.gov processed this record on January 16, 2009