- What is BPH or enlarged prostate?
- Does every man eventually have an enlarged prostate as they age?
- What options does a man have to relieve the symptoms of BPH?
- What is Prostiva RF Therapy?
- How does TUNA/Prostiva work, and how is it different from other treatments?
- What is it like to undergo the TUNA/Prostiva treatment?
- What results can I expect and when
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Medtronic PROSTIVA RF Therapy for Enlarged Prostate
Overview
PROSTIVA RF (radio frequency) Therapy is a minimally-invasive treatment for symptomatic benign prostatic hyperplasia (BPH). The PROSTIVA RF Therapy System delivers low-level radio frequency energy directly into the prostate and destroys the prostate tissue, improving the symptoms of BPH.
Benefits
- Provides long-term relief of BPH symptoms from one treatment session
- Associated with few side effects and adverse events.
- Takes less than 30 minutes on average
- Can be performed under local anesthesia
- Treatment is targeted; adjacent tissues and organs are preserved.
- Cost effective: Can be performed as an outpatient procedure in a urologist's office
- Affordable: Covered by Medicare and most private health plans
PROSTIVA RF Therapy System
- The major components of the PROSTIVA System are the radio frequency (RF) generator, the disposable handpiece and the telescope.
- The generator is a portable, line-powered, dual channel generator, capable of producing up to 15 watts per channel. The generator produces RF energy at 473 kHz. This is the same approximate frequency as cautery and other RF ablation devices.
- The handpiece, including the RF cable, comes as a complete sterile assembly that contains two insulated needles. The entire assembly is a single use, disposable device.
- The telescope allows the physician to view anatomical landmarks and the needle deployment sites directly.
Procedure and Follow-up
- PROSTIVA RF Therapy total procedure time is less than 30 minutes, with some preparation and recovery time required. The PROSTIVA generator lesion time is 22 percent faster than the previous generation of RF therapy.
- PROSTIVA RF Therapy treats the median and lateral lobe as well as asymmetrical prostates. (Exception: Median lobes that protrude into the bladder and collapse over the bladder neck.)
- The device is inserted into the urethra and deploys two custom-set needle electrodes into the obstructing prostate tissue. The needles emit radio frequency (RF) energy directly and precisely into the prostate, causing thermal ablation of the obstructing tissue.
- Most patients can undergo the PROSTIVA procedure with only an oral sedative and a local anesthetic.
- Most patients are able to return to normal activities within a few days.
Safety Profile
- Clinical trials demonstrated that the RF therapy procedure can be performed without the need for general or regional (spinal) anesthesia; most patients require only mild oral sedation, topical anesthesia, and/or a prostate block.
- RF therapy is associated with few side effects and adverse events, which may include obstruction, catheterization, bleeding, pain/discomfort, urgency, frequency and urinary tract infection.
History
- Previously, the only BPH treatment options were daily drug therapy or surgery.
- With the development of minimally invasive therapies, patients now have a selection of BPH treatment choices to better meet their lifestyle and health needs.
- RF energy has been used in medical procedures since the 1920s. In cardiac and neurosurgery treatments, RF has been recognized as a safe and effective treatment for many medical conditions.
- Initial pilot studies of the first generation of RF therapy for the prostate began in 1994, followed by a series of clinical trials to determine safety, efficacy and durability. When comparing side effects and adverse events, RF therapy compared favorably to TURP in a major U.S. clinical trial.
- TUNA Therapy, the previous generation of PROSTIVA RF Therapy, was introduced in the United States in 1996 for the treatment of the symptoms of BPH.
- In November 2005, the Food and Drug Administration granted 510K clearance to PROSTIVA RF Therapy as equivalent to TUNA® Therapy.
- Medtronic released the PROSTIVA RF Therapy System to the market in Spring 2006.