Impact Of Sacral Neuromodulation On Urine Markers For Int... | NCT00704457

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

NCT00704457

Sponsor

Kenneth Peters, MD

Status

Completed

Last Update Posted

Aug 2, 2013Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Interstitial Cystitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jun 24, 2008

First Submission Date that Met QC Criteria

Jun 24, 2008

First Posted Date

Jun 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2013

Last Update Posted Date

Aug 2, 2013Estimated

Name	Class
Corewell Health East	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

11Actual

Label	Type	Description	Intervention Names
A		One arm study. Urine collection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Male

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who have undergone sacral nerve stimulation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Peters, MD	Corewell Health East	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beaumont Hospital - Royal Oak		Royal Oak	Michigan	48073	United States

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided