The Problem
Benign Prostatic Hyperplasia, or BPH, is a common ailment in which the prostate enlarges as men grow older. BPH is a widespread disorder that affects nearly 40 million Americans and over 500 million aging men worldwide. Over 40% of men in their 50s and over 70% of men in their 60s have BPH. While BPH is a benign condition and unrelated to prostate cancer, it can greatly affect a man’s quality of life. The global BPH therapeutics market was valued at $10B in 2017 and is projected to reach $20B by 2025.
The Solution
Physicians have used heat to ablate prostates since 1985. However, these procedures require the insertion of a microwave antenna into the prostate. The procedures can be painful and have been associated with a high rate of complications. Thermofield therapy is being developed as a completely noninvasive treatment that is side-effect free and gradually shrinks the prostate over a series of treatments.
The Problem with Currently Available Therapy For BPH
Pharmaceutical agents – alpha-reductase inhibitors and alpha-blockers are often used in combination to treat BPH. They work by blocking the action of 5-alpha reductase, which causes prostate enlargement, and by relaxing muscles in the prostate. Many urologists believe that these drugs are overprescribed and do not offer significant long term benefits for patients. Recent studies indicate that patients taking these drugs are a greater risk of permanent sexual side effects (ED), a higher risk of lethal cancer, and an increased risk of diabetes.
Most Common Side-Effects of 5-alpha Reductase Inhibitors [1]
Loss or reduced libido
Erectile dysfunction
Orgasmic and ejaculatory dysfunction
Development of high-grade PCa tumors
Potential negative cardiovascular events
Depression
Most Common Side-Effects of Alpha Blockers [2]
Dizziness
Fainting
Headaches
Lightheadedness
Low blood pressure
TUMT vs. Thermofield® Therapy
While both procedures use heat to shrink or ablate the prostate, one procedure is far more pleasant for patients than the other. TUMT involves inserting a special microwave urinary catheter into the hyperplastic prostatic urethra. The microwave antenna, within the catheter, then emits microwaves to heat and destroy the surrounding prostate tissue. The procedure can take from 30 minutes to one hour and is generally well tolerated by patients. However, the procedure can cause considerable swelling and irritation of the prostate tissue in some patients. Urologists often place a Foley catheter to prevent the patient from having urinary retention. After three to five days, the Foley catheter can be replaced by a temporary prostatic stent to improve voiding without exacerbating symptoms.
The main risks of transurethral microwave thermotherapy include:
Urinary retention
Infection
Post-procedural pain
Retrograde ejaculation
Intense pain during the procedure
Urination pain for several weeks
The Potential Benefits of Thermofield® Technology
Thermofield® therapy, by contrast, is an extraordinarily mild procedure. The patient simply sits on the applicator pad for 30 to 60 minutes. The absorbed energy gently heats the prostate gland to about 110°F. This mild heating has a powerful effect that activates the immune system and dramatically increases local blood flow in and around the prostate. Over a series of heat treatments, the prostate shrinks, normal urinary function is restored for the patient and catheterization is not necessary.
The primary risks of Thermofield® therapy include:
Small risk of skin blister: < 1% when surface temperatures are maintained at or below 42°C
Some patients may experience slight discomfort during the procedure; however, this can be mitigated by turning down the duty cycle on the control unit.
1. Korean J Urol. 2014 Jun; 55(6): 367–379
2. Lepor H. Alpha-blockers for the treatment of benign prostatic hyperplasia. Rev Urol. 2007;9(4):181–190.