Treatment Options

Risks and Warnings

When should the Prolieve System not be used (Important SAfety Information)?

Please inform your physician if:

  • 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.