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

August 1, 2013 updated by: Kenneth Peters, MD

Impact Of Sacral Neuromodulation On Urine Markers For IC

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

Study Overview

Status

Completed

Conditions

Interstitial Cystitis

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone sacral nerve stimulation.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Male

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
A One arm study. Urine collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth Peters, MD

Collaborators

William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria