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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Michael Chancellor, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01739946
First received: November 28, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®. Specifically, we will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.


Condition
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 William Beaumont Hospitals:

Primary Outcome Measures:
  • Variability of Nerve Growth Factor (NGF) and Chemokine/cytokine levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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®.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Implanted subject
Subjects with Interstim implanted
Controls
Subjects without Interstim implanted

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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)

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739946

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

No publications provided

Responsible Party: Michael Chancellor, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01739946     History of Changes
Other Study ID Numbers: 2012-143
Study First Received: November 28, 2012
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 25, 2014