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

July 27, 2017 updated by: Michael Chancellor, MD
The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Implanted subject
Subjects with Interstim implanted
Controls
Subjects without Interstim implanted

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Chancellor, MD

Collaborators

William Beaumont Hospitals

Investigators

  • Principal Investigator: Michael Chancellor, MD, William Beaumont Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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