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

This study has been completed.
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00704457
First received: June 24, 2008
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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


Condition
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)
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 Southeast Michigan.

Exclusion Criteria:

  • Male
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Kenneth Peters, MD
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov 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
IC
Sacral Nerve Stimulation

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

ClinicalTrials.gov processed this record on September 16, 2014