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

NCT ID: NCT00704457

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Interstitial Cystitis

Keywords

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Interstitial Cystitis IC Sacral Nerve Stimulation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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A

One arm study. Urine collection.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Male
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role collaborator

Kenneth Peters, MD

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Peters, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kenneth Peters, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2004-024

Identifier Type: -

Identifier Source: org_study_id