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

This study has been completed.
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals Identifier:
First received: June 24, 2008
Last updated: August 1, 2013
Last verified: August 2013
Urine will be collected and sent to the University of Maryland. Urines will be analyzed for urine markers.

Interstitial Cystitis

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

Resource links provided by NLM:

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
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)
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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

  • Male
  Contacts and Locations
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Please refer to this study by its identifier: NCT00704457

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

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals Identifier: NCT00704457     History of Changes
Other Study ID Numbers: 2004-024
Study First Received: June 24, 2008
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Interstitial Cystitis
Sacral Nerve Stimulation

Additional relevant MeSH terms:
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases processed this record on November 24, 2015