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

NCT01739946 | Completed

• 1 other identifier: 2012-143
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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®.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Nerve Growth Factor (NGF) levels

  pg/ml

  4 weeks

Study Arms (2)

Implanted subject

Subjects with Interstim implanted

Controls

Subjects without Interstim implanted

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Chancellor, MD: lead
• Corewell Health East: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (1)

• 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.

  PMID: 26663686 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Chancellor, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 4, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)