III. CONTRAINDICATIONS
The contraindications for ProlieveTM are:
· Patients whose pain response has been significantly decreased by any means (previous
surgery, regional or local anesthetic, or other relevant condition which is determined
by the physician upon evaluation) because the patients' ability to detect pain is a
treatment safety mechanism.
* Severe urethral stricture preventing catheterization.
· Current urinary or prostatic infection.
Presence of a penile or urinary sphincter implant.
· Prostate size <20g>80g.
· Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e.,
claudication of the buttocks or perineum).
PMA P030006: SSED page 1 of 15
Protruding median lobe resulting in a "ball-valve" type of obstruction at the bladder
neck.
* Evidence of prostatic cancer or bladder cancer.
• Presence of metallic implants, e.g. pelvic, femur, penile prosthesis, etc.
Presence of implanted cardiac pacemakers, or defibrillators.
* Previous transurethral prostatectomy.
* Patients interested in the preservation of future fertility.
* Patients with a previous history of pelvic radiation.
* Patients with coagulation disorders.
* Patients with renal impairment.
* Patients with neurological disorders that might affect bladder function.
* Patients with bladder stones and large post voiding residual (greater than 250 mL).
