NCT00704457

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2013

Enrollment Period

2.8 years

First QC Date

June 24, 2008

Last Update Submit

August 1, 2013

Conditions

Interstitial Cystitis

Keywords

Interstitial CystitisICSacral Nerve Stimulation

Outcome Measures

Primary Outcomes (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.

    1 year

Study Arms (1)

A

One arm study. Urine collection.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone sacral nerve stimulation.

You may qualify if:

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

You may not qualify if:

  • Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urines were collected and sent for urine marker analysis.

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Kenneth Peters, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 25, 2008

Study Start

February 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2007

Last Updated

August 2, 2013

Record last verified: 2013-08

Locations

US(1)