Patient Name:

Age:

Date:

Procedure: Artifical Urinary Sphincter (AUS-800)

Indications:

Patient is a male with stress urinary incontinence from previous prostate surgery for benign and malignant conditions or has an incompetent sphincter secondary to neurological disease. Urodynamic studies have confirmed the presence of Type III stress urinary incontinence with a low valsalva leak point pressure.

Alternatives:

Alternatives include watchful waiting, Kegel exercises, behavioral/biofeedback/electrical stimulation therapy, injection of urethral bulking agents and male sling.

Risks/Complications:

The risks and complications of the procedure where extensively discussed with the patient. The general risks of this procedure include, but are not limited to bleeding, transfusion, infection, wound infection/dehiscence, pain, scaring of tissues, failure of the procedure, potential injury to other surrounding structures, deep venous thrombosis, pulmonary embolus, myocardial infarction, heart failure, stroke, death or a long-term stay in the Intensive Care Unit (ICU). Additionally, mentioned were the possible serious complications of the anesthesia to include cracked teeth, airway damage, aspiration, pneumonia, spinal head-ache, nerve damage, spinal canal bleeding and malignant hyperthermia. Your anesthesiologist will discuss the risks and complications in more depth separately. Additional procedures may be necessary.

The specific risks of this procedure include, but are not limited to: persistent incontinence, late failure of the AUS by pump/reservoir/cuff failure and fluid leakage with resultant recurrent incontinence and require partial or complete replacement of the prosthetic, atrophy of the urethra that would require further therapy with bulking agents or replacement of the AUS-800 or placement of an additional cuff to convert to a double cuffed system, acute and chronic infection that may require removal of the device, erosion of device parts through skin or urethra requiring removal, chronic epididymal or testicular pain, , numbness or hyperasthetic scrotal/perineal skin, the procedure uses a foreign body material (silicone polymer) that can be infected in the future, will require prophylactic antibiotics before other surgical and dental procedures to avoid possible seeding of the implant with bacteria, if the mesh does get infected then long-term antibiotics or removal of the mesh may be necessary.

You understand the procedure, general and specific risks as discussed and agree to proceed with the procedure. You also understand that not every possible complication can be listed in this counseling note and additional risks are possible, although unlikely.

Physician's Signature: ________________________________ Date: __________________

Patient Signature: __________________________________ Date: __________________