Urinary Biomarkers For Objective Measurement Of InterStim... | NCT01739946

Studies
Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.

NCT01739946

Sponsor

Michael Chancellor, MD

Status

Completed

Last Update Posted

Aug 1, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Overactive Bladder

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

Jul 2017

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

Oct 2012

Primary Completion Date

Jun 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Nov 28, 2012

First Submission Date that Met QC Criteria

Nov 28, 2012

First Posted Date

Dec 4, 2012Estimated

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

Jul 27, 2017

Last Update Posted Date

Aug 1, 2017Actual

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

The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

Detailed Description

This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.

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

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Implanted subject		Subjects with Interstim implanted
Controls		Subjects without Interstim implanted

Measure	Description	Time Frame
Nerve Growth Factor (NGF) levels	pg/ml	4 weeks

Eligibility Module

Eligibility Criteria

OAB subjects (n=10 Phase I and n=10 Phase II)

Inclusion Criteria:

Female
Age 18-75 years
Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit.
At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary.
InterStim® treatment naïve or being revised with a new lead

Exclusion Criteria:

Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review
Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I)
Revision of only the IPG (without replacement of the tined lead)
More than one InterStim® device being placed (undergoing bilateral stimulation)

Controls (n=10)

Inclusion:

Female
Age 18-75 years
Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence)
American Urological Association (AUA) symptom score of ≤4

Exclusion:

-History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects with either have OAB and will be undergoing an InterStim® implant (InterStim® group) or do not have bladder symptoms or an InterStim® device (Control group)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Michael Chancellor, MD	Corewell Health East	Principal Investigator

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26663686	Derived	Peters KM, Jayabalan N, Bui D, Killinger K, Chancellor M, Tyagi P. Effect of Sacral Neuromodulation on Outcome Measures and Urine Chemokines in Interstitial Cystitis/Painful Bladder Syndrome Patients. Low Urin Tract Symptoms. 2015 May;7(2):77-83. doi: 10.1111/luts.12054. Epub 2014 Mar 17.

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications