Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.
Completed
- Conditions
- Overactive Bladder
- Registration Number
- NCT01739946
- Lead Sponsor
- Michael Chancellor, MD
- 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®.
- Detailed Description
This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Nerve Growth Factor (NGF) levels 4 weeks pg/ml
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States