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

Michael Chancellor, MD

Status

Completed

Conditions

Overactive Bladder

Study type

Observational

Funder types

Other

Identifiers

2012-143

Details and patient eligibility

About

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

Full description

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

Enrollment

30 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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