InterStim® Therapy for Urinary Control:  Product technical manual must be reviewed prior to use for detailed disclosure.
 Indications:
InterStim Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
Contraindications:
Patients are contraindicated for implant of the InterStim System if they have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.  Also, diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) is contraindicated because diathermy's energy can be transferred through the implanted system (or any of the separate implanted components), which can cause tissue damage and can result in severe injury or death.  Diathermy can damage parts of the neurostimulation system.
Precautions/Adverse Events: 
Warning:  This therapy is not intended for patients with mechanical
obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.
Safety and effectiveness have not been established for: bilateral stimulation, patients with neurological disease origins such as multiple sclerosis, pregnancy and delivery, or for pediatric use under the age of 16.  System may be affected by or adversely affect cardiac pacemakers or therapies, cardioverter defibrillators, electrocautery, external defibrillators, ultrasonic equipment, radiation therapy, magnetic resonance imaging (MRI), theft detectors and screening devices.  Adverse events related to the therapy, device, or procedure can include: pain at the implant sites, lead migration, infection or skin irritation, technical or device problems, transient electric shock, adverse change in bowel or voiding function, numbness, nerve injury, seroma at the neurostimulator site, change in menstrual cycle, and undesirable stimulation or sensations.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.