tumt
Benign prostatic hyperplasia (BPH) is the most common non-cancerous growth found in humans. It affects at least 50% of men over the age of 60; an astounding 1 in 4 men in the United States require treatments for BPH by the age of 80. As the population matures and men continue to live longer, BPH is expected to become an even larger and costlier public health issue.
BPH is characterized by excess tissue growth in the prostate. Over time, enlargement of the gland squeezes the urethra causing a variety of urinary symptoms including frequency, urgency and straining. The condition may cause considerable discomfort and diminished quality of life.
TUMT: A BREAKTHROUGH TREATMENT
Despite its prevalence, few effective treatments exist for BPH. Until recently, physicians could offer patients only two treatments - surgery and medications - to relieve the symptoms of BPH. Relief is not without a price, as surgery and drugs often carry significant risks and costs.
An alternative to surgery uses Transurethral Microwave Thermotherapy (TUMT™), a safe, effective method of elimination of excess prostate cells with minimal patient risk or inconvenience. The Prostatron was granted U.S. Food and Drug Administration (FDA) approval in April of 1996.
THERMOTHERAPY - TUMT
Thermotherapy, or TUMT, is the minimally invasive use of controlled heat to treat prostate disease. As early as 1984,k the journal Prostate reported on the use of microwave energy to treat prostate cancer. Experiment using thermotherapy (Devonec, et al.) for BPH found that temperatures above 45°C were effective at destroying excess prostate tissue. This work set the stage for the development of EDAP Technomed's Prostatron, which employs temperatures above 45°C.
Years of research went into the design of the Prostatron, a state-of-the-art medical system that delivers microwave energy to targeted areas of the enlarged prostate. EDAP Technomed's Prostatron represents a medical breakthrough in BPH therapy. Prostatron's uniqueness lies in its ability to effectively heat and eliminate excess prostate cells, while protecting adjacent tissues with a patented cooling system. With excess prostate tissue eliminated, pressure on the urethra is relieved, resulting in an improvement in symptoms and urine flow.
TUMT: Clinical Results Impressive
Numerous clinical studies in the United States and in Europe, including several that followed patients for more than five years, show that TUMT provides impressive clinical results - far better than those associated with medication and comparable to surgery in providing relief of symptoms. When data from several European studies were combined, it was determined that 72% of those who had TUMT were successfully treated (with success defined as a 75% improvement in individual and combined parameters of symptoms and urine flow rate) vs. 93% for patients who had the surgical TURP procedure.
Based on these clinical studies, specific conclusions about TUMT include:
- TUMT significantly improves symptoms and urine flow rate
- TUMT (non-surgical) is nearly as effective as TURP (surgical) at improving symptoms
- TUMT does not cause any major complications or side-effects
- TUMT preserves sexual function
- TUMT is durable
Relating to technical aspects, it was found that TUMT:
- Requires no local or general anesthesia
- Requires no hospitalization
- Is easy to administer
- Is technically safe
- Preserves adjacent urethral tissue
In the United States, a clinical study at the Mayo Clinics in Rochester, MN, and Jacksonville, FL, compared TUMT to placebo (simulated procedure but without application of heat) and found that the TUMT group (75 patients) had twice the level of improvement in their symptoms as the non-TUMT group; 72% of TUMT patients had successful treatment, and 58% had improved urine flow rates. The Mayo study confirmed results from a 1994 study at Charing Cross Hospital in London, U.K., where 77.5% of patients had improved symptom scores, and 46% of patients had improved urine flow rates. This study was subsequently published in The Lancet.
These and other findings strongly suggest that TUMT has much to offer BPH patients, especially those wishing to avoid surgery and its potential side-effects. TUMT is also an alternative for individuals who may not tolerate general anesthesia, which is required for surgery. Because there appear to be no risks associated with TUMT, it allows patients to be treated sooner rather than living with symptoms that affect the quality of their lives.
A Lasting Treatment Response
Studies indicate that the improvement in symptoms and urine flow rate occurred beginning six weeks after treatment. When surveyed almost four years after treatment, the majority of the 169 patients in the FDA study stated they still were perceiving the benefits of TUMT. Further studies of TUMT patients up to five years later showed the treatment to be effective and lasting. TUMT presents a safe, durable, non-surgical alternative to current treatments.
TUMT represents a breakthrough in its ability to protect the urinary tract and adjacent structures from high temperatures during the treatment. This is accomplished through a cooling system in which water is continually circulated within the catheter applicator. Temperatures are monitored throughout the procedure. In studies, post-TUMT magnetic resonance imaging (MRI) of the prostate shows a clear delineation between the treated area and the unaffected adjacent area.
