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

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