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

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ClinicalTrials.gov Identifier: NCT00704457
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : August 2, 2013
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

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

Condition or disease
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
Actual Enrollment : 11 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact Of Sacral Neuromodulation On Urine Markers For IC
Study Start Date : February 2004
Primary Completion Date : December 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
A
One arm study. Urine collection.



Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
Urines were collected and sent for urine marker analysis.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 Southeast Michigan.

Exclusion Criteria:

  • Male

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704457


Locations
United States, Michigan
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00704457     History of Changes
Other Study ID Numbers: 2004-024
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Keywords provided by Kenneth Peters, MD, William Beaumont Hospitals:
Interstitial Cystitis
IC
Sacral Nerve Stimulation

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases