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NCT00704457 Clinical Trial

Impact Of Sacral Neuromodulation On Urine Markers For Interstitial Cystitis (IC)

Interstitial Cystitis Clinical Trial

Official title:
Impact Of Sacral Neuromodulation On Urine Markers For IC

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00704457
Other study ID # 2004-024
Secondary ID
Status Completed
Phase N/A
First received June 24, 2008
Last updated August 1, 2013
Start date February 2004
Est. completion date December 2007

Study information
Verified date August 2013
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date December 2007
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Male

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Beaumont Hospital - Royal Oak Royal Oak Michigan

Sponsors (2)
Lead Sponsor Collaborator
Kenneth Peters, MD William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The purpose of this study is measure urine biomarkers levels in patients with interstitial cystitis who have elected to undergo sacral nerve stimulation as a treatment modality for their disease. 1 year No
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