Important Safety Information for Prostiva RF Therapy System
Indications:
The Prostiva RF Therapy System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
Adverse Events:
Possible side effects include obstruction (blockage), urinary retention, bleeding, blood in urine, pain/discomfort, urgency to urinate, increased urinary frequency, and urinary tract infection. You may also experience a minor burning sensation when urinating for 1 to 2 weeks following the treatment.
CAUTION:
Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions and warnings, please refer to the System User Guide.
For additional information about Prostiva RF Therapy, please see the complete Prostiva RF Therapy System Safety Data.
Available by prescription only. This therapy is not for everyone. Talk with your doctor about whether it is right for you.
Last updated: 3 Aug 2008
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