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

This study has been completed.
William Beaumont Hospitals
Information provided by (Responsible Party):
Michael Chancellor, MD, William Beaumont Hospitals Identifier:
First received: November 28, 2012
Last updated: January 12, 2017
Last verified: January 2017
The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

Overactive Bladder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.

Resource links provided by NLM:

Further study details as provided by Michael Chancellor, MD, William Beaumont Hospitals:

Primary Outcome Measures:
  • Variability of Nerve Growth Factor (NGF) and Chemokine/cytokine levels [ Time Frame: 4 weeks ]
    The proposed work will determine the variability of NGF and chemokine/cytokine levels in OAB patients and controls and the modulation of these levels by InterStim®.

Enrollment: 24
Study Start Date: October 2012
Study Completion Date: December 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Implanted subject
Subjects with Interstim implanted
Subjects without Interstim implanted

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

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)


  • 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


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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01739946

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Michael Chancellor, MD
William Beaumont Hospitals
Principal Investigator: Michael Chancellor, MD William Beaumont Hospitals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Chancellor, MD, Principal Investigator, William Beaumont Hospitals Identifier: NCT01739946     History of Changes
Other Study ID Numbers: 2012-143
Study First Received: November 28, 2012
Last Updated: January 12, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms processed this record on May 25, 2017