InSite for Over Active Bladder

Approximately 30 million Americans meet the criteria for overactive bladder (OAB). Urinary
voiding dysfunction symptoms impose a significant physical and psychosocial impact on
individuals, including loss of self-esteem and a decrease in the ability to maintain an
independent lifestyle. These symptoms can substantially affect a subject's daily activities.

Patients with OAB are managed with diet modification, bladder training or retraining, pelvic
muscle rehabilitation, medication and biofeedback. Medications are used as the first-line
therapy for urgency frequency and urinary urge incontinence.

InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the
treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence
and significant symptoms of urgency-frequency alone or in combination, in subjects who have
failed or could not tolerate more conservative treatments.

InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of
the trail and Phase II the non-randomized portion.

Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects
randomized to SMT.

Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297
enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and
Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of
OAB.

Inclusion Criteria:

- Have a diagnosis of OAB including urinary urge incontinence or urgency-frequency

- Be male or female at least 18 years of age or older

- Be able to consent to participate by signing the Informed Consent

- Be willing and able to attend visits and comply with the study protocol including
adequate operation of equipment

- Have failed or are not a candidate for more conservative treatment (e.g. pelvic floor
training, biofeedback, behavioral modification)

- Have failed or could not tolerate (stopped taking medication due to lack of efficacy
or intolerable side effects) at least one anticholinergic or antimuscarinic
medication AND have at least one anticholinergic or antimuscarinic medication not yet
attempted

- Have been on current regiment of OAB medications or have not been on any OAB
medications, for at least 4 weeks prior to beginning the baseline voiding diary

Exclusion Criteria:

- Have severe or uncontrolled diabetes or diabetes with peripheral nerve involvement

- Have concomitant medical conditions which would limit the success of the study
procedure

- Have skin, orthopedic or neurologic anatomical limitations that could prevent
successful placement of an electrode

- Have neurological diseases such as multiple sclerosis, clinically significant
peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)

- Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic
exposure, or RF energy exposure

- Have urinary tract mechanical obstruction such as benign prostatic hypertrophy,
cancer, or urethral stricture

- Have symptomatic urinary tract infection (UTI)

- Have implantable neurostimulators, pacemakers, or defibrillators

- Have primary stress incontinence or mixed incontinence where the stress component
overrides the urge component

- Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12
months

- Be a woman who is pregnant or planning to become pregnant or are a woman of
child-bearing potential who is not using a medically-acceptable method of birth
control

- Have a life expectancy of less than one year

- Have plans to enroll in another investigation device or drug trial during their
participation in this trial, or currently enrolled in an investigational device or
drug trial