You are not able to feel pain. Microwave treatment is not indicated in patients whose response to pain has been reduced. This reduced pain response may result from surgery, regional or local anesthetic, or relevant condition that is determined by the physician upon evaluation.
A catheter cannot be passed through your urethra.
You have a urinary infection.
You have a prostate infection.
You have undergone a procedure to insert a penile or urinary sphincter implant.
You have clogging of the arteries with intermittent claudication or Leriches Syndrome.
You had your prostate removed.
You have been diagnosed with cancer of the prostate or the bladder.
You have metallic hip or leg implants.
You have an implanted cardiac pacemaker, or defibrillator.
You are interested in having children.
You have had any history of pelvic radiation.
You have an abnormality of your blood that prevents it from clotting.
You have any kidney disease.
You cannot urinate without help of some kind.
You have stones in your bladder.

Disadvantages of the Prolieve System

Unlike medication, treatments with the Prolieve System are performed at a physician's office or at a local hospital in the outpatient unit.
The patient must be a good candidate for the treatment.
The procedure requires some exposure and may be a bit embarrassing and or uncomfortable.
There may be side effects including: anal irritation, bladder spasms, bleeding (mild to excessive), bowel irritation, chronic pain at the site, complete urinary retention, incomplete urinary retention, erectile dysfunction, pressure sensation (minimal), prostatitis, retrograde ejaculation, urethral injury (irritation), urinary clot retention, urinary incontinence, urinary tract infection, urinary urgency.

Risks of the Prolieve System

There have been serious, but rare, side effects from other transurethral microwave therapy device treatments. However, none of these have been experienced by any of the patients treated with the Prolieve System. Please consult with your physician.

During the clinical study of the Prolieve System, the following events were directly attributed to the procedure: bladder spasms, urethral irritations, and complete urinary retention (requiring catheterization). Other side effects reported were those associated with BPH. The majority of the side effects resolved within 2 weeks to 1 month and required little or no medication.

General warnings and precautions

It is very important that you are awake during this procedure. Your doctor will rely on your sensations of pain or heat as a guide during treatment.

Important information about the Prolieve Thermodilitation^® System.

INDICATIONS: The Prolieve Thermodilatation^® System is a transurethral microwave therapy device for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with a prostate size of 20 to 80 grams and prostatic urethra length between 1.2 cm and 5.5 cm and in whom drug therapy (Finasteride or Proscar®) is typically indicated.
CONTRAINDICATIONS: Patients who have significantly decreased pain responses, severe urethral stricture prohibiting catheterization, current urinary or prostatic infection, penile or urinary sphincter implants, prostate sizes <20 g or >80 g, peripheral arterial disease with intermittent claudication or Leriche's Syndrome, protruding median lobe with obstruction, metallic implants, implanted cardiac pacemakers or defibrillators, previous transurethral prostatectomy, renal impairment, coagulation disorders, neurological disorders that may affect bladder function, bladder stones, evidence of prostate or bladder cancer or have an interest in the preservation of future fertility.
WARNINGS AND PRECAUTIONS: All components of the Prolieve System must be used in accordance with the User Manual. The emission of microwave energy must be off during placement and removal of the catheter. Patient comments of pain or excess heat should be investigated. Failure to monitor adequately and deliver the procedure per User Manual may lead to decreased patient safety and/or reduced clinical effectiveness. A single high dose of microwave radiation to the testes, or testicular heating for a prolonged period, may result in temporary or permanent sterility. No anesthetic other than aqueous-based topical intraurethral anesthetic used for catheter placement is recommended. The safety and effectiveness of the Prolieve System for men <50 and >80 years old has not been established in clinical studies. If procedure kit seal or internal sterile packaging seals are damaged or broken, the contents may not be sterile and could cause infection. POTENTIAL ADVERSE EFFECTS: that may occur include but are not limited to bleeding, bowel irritation, urethral injury (irritation), chronic pain at site, bladder spasms, urinary retention (complete or incomplete), urinary incontinence, prostatitis, pressure sensation, urinary urgency, urinary tract infection, urethral tear, anal irritation, urethral stricture, infertility, retrograde ejaculation and erectile dysfunction. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Prolieve is a trademark of Medifocus, Inc.