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.
- Active urinary tract infection
- Neurogenic, decompensated, or atonic bladder
- Urethral strictures or muscle spasms that prevent insertion of the cartridge sheath
- Bleeding disorders or patients taking anticoagulation medication unless antiplatelet medication has been discontinued for at least 10 days
- ASA class group V patients
- Clinical or histological evidence of prostatic cancer or bladder cancer
- Prostate gland which is less than 34mm or greater than 80mm in transverse diameter
- Presence of any prosthetic device in the region that may interfere with the procedure
- Patients whose prostate has been previously treated with non-pharmacological therapies
- Presence of cardiac pacemaker, implantable defibrillator, or malleable penile implants
- Patients with any component(s) of an implantable neurostimulation system
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 Safety Data.