InterStim® Amplitude Study

Inclusion Criteria:

1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3‐day
baseline voiding diary demonstrating at least 3 UUI episodes

2. Female subjects 18 years of age or older

3. Candidate for InterStim Lead Placement

4. Willing and able to accurately complete voiding diaries, questionnaires, attend
visits, and comply with the study protocol (which includes maintenance of InterStim II
programming settings over the course of the study)

5. Willing and able to provide signed and dated informed consent

6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder
(OAB) medication

Exclusion Criteria:

1. Have neurological conditions such as multiple sclerosis, clinically significant
peripheral neuropathy or spinal cord injury

2. History of diabetes unless the diabetes is well‐controlled through diet and/or
medications

3. Symptomatic urinary tract infection (UTI)

4. Have primary stress incontinence or mixed incontinence where the stress component
overrides the urge component

5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to
have botulinum toxin treatment during the study

6. Implanted with a neurostimulator, pacemaker, or defibrillator

7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic
exposure, or radio frequency (RF) energy exposure not included within the scanning
conditions provided with the MRI Guidelines for InterStim Therapy

8. Women who are pregnant or planning to become pregnant

9. Characteristics indicating a poor understanding of the study or characteristics that
indicate the subject may have poor compliance with the study protocol requirements.

10. Currently enrolled or planning to enroll in a potentially confounding clinical study
during the course of the study (co-enrollment in concurrent studies is only allowed
when documented pre‐approval is obtained from the Medtronic study manager (or
designee).