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

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ClinicalTrials.gov Identifier: NCT01739946
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Michael Chancellor, MD, William Beaumont Hospitals

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®.

Condition or disease
Overactive Bladder

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

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.
Study Start Date : October 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Nerve Growth Factor (NGF) levels [ Time Frame: 4 weeks ]
    pg/ml



Information from the National Library of Medicine

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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)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Chancellor, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01739946     History of Changes
Other Study ID Numbers: 2012-143
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
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