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

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

The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

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

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