Prolieve BPH Treatment

What is Benign Prostatic Hyperplasia (BPH)?

Millions of aging men experience symptoms resulting from Benign Prostatic Hyperplasia (BPH), a non-cancerous urological disease in which the prostate enlarges and constricts the urethra. The prostate is a walnut-sized gland surrounding the male urethra that produces seminal fluid and plays a key role in sperm preservation and transportation. The prostate frequently enlarges with age. As the prostate expands, it compresses or constricts the urethra, thereby restricting the normal passage of urine. This restriction may require a patient to exert excessive bladder pressure to urinate. Because urination is one of the body’s primary means of cleansing impurities, the inability to urinate adequately increases the possibility of infection and bladder and kidney damage.

BPH Symptoms

The symptoms of BPH usually involve problems with emptying the bladder or storing urine in the bladder. However, the severity of the symptoms can vary widely, from mild and barely noticeable to serious and disruptive. Common BPH symptoms include:

  • Pushing or straining to begin urination
  • A weak urinary stream
  • Dribbling after urination
  • A frequent need to urinate, sometimes every 2 hours or less
  • A recurrent, sudden, or uncontrollable urge to urinate
  • Feeling the bladder has not completely emptied after urination
  • Pain during urination
  • Waking at night to urinate

In extreme cases, a man may be completely unable to urinate. In such situations, emergency medical attention is required.

An enlarged prostate does not cause prostate cancer or directly affect sexual function. However, many men experience sexual dysfunction and BPH symptoms at the same time. This is due to aging and the common medical conditions older men often encounter, including vascular disease and diabetes. Since all these conditions take place with aging, sexual dysfunction tends to be more pronounced in men with BPH.

BPH Complications

BPH is not a form of prostate cancer and does not lead to prostate cancer. Thus, BPH is not life-threatening. However, as many men know, BPH may be lifestyle-threatening and can cause great discomfort, inconvenience, and awkwardness and complications such as:

    • Acute urinary retention, which is a condition that results in a complete inability to urinate. A tube called a catheter may be needed to drain urine from the bladder.
    • Chronic urinary retention, which is a partial blockage of urine flow that causes urine to remain in the bladder. In rare cases, this may lead to kidney damage if it goes undiagnosed for too long.
    • Urinary tract infection, which can cause pain or burning during urination, foul-smelling urine, or fever and chills.
    • Other complications from BPH may include bladder stones or bladder infections.
    • Having BPH does not directly affect one’s sexual function. However, it is common for the symptoms of BPH and sexual dysfunction to occur at the same time.

Prevalence of BPH and Treatment Market Potentials

BPH is an age-related disorder, the incidence of which increases with maturation of the population. Industry estimates suggest that nine million men in the United States experience BPH symptoms and more than 30 million men are affected by BPH worldwide. As the population continues to age, the prevalence of BPH will continue to increase. It is generally estimated that approximately 50% of all men over the age of 55 and 90% of all men over 75 will have BPH symptoms at various times.

Treatment Alternatives for BPH

Surgical Intervention

The primary surgical treatment for BPH had been transurethral resection of the prostate, or TURP, a procedure in which the prostatic urethra and surrounding diseased tissue in the prostate are trimmed with a telescopic knife, thereby widening the urethral channel for urine flow. While the TURP procedure generally has been considered the most effective treatment available for the relief of BPH symptoms, the procedure has shortcomings. In the first instance, TURP generally requires from one to three days of post-operative hospitalization. In addition, a substantial percentage of patients who undergo TURP encounter significant complications, which can include painful urination, infection, retrograde ejaculation, impotence, incontinence and excessive bleeding. Furthermore, the cost of the TURP procedure and the related hospitalization is high, without even taking into account the costs of lost work time, which could amount to several weeks, or the costs related to adverse effects on patients’ quality of life.

Drug Therapy

Several different types of drugs, such as Alpha-Blockers (Flomax®) and Alpha Reductase Inhibitors (Proscar®) are prescribed by doctors to treat the symptoms of BPH. Drug therapy costs approximately $1,000 per year or more in the U.S. and must be maintained for life and does not offer consistent relief to a large number of BPH patients. In fact, studies have shown that 45% of patients who begin drug therapy for BPH drop out within the first year, primarily due to the ineffectiveness of currently available drug therapies. All of the currently available BPH drugs also have appreciable side effects, such as: headache, fatigue, impotence, dizziness, and low blood pressure.

Accordingly, neither drug therapies nor the surgical alternatives appear to provide fully satisfactory, cost-effective treatment solutions for BPH sufferers.

Our Approach: The Prolieve® Thermodilatation System

Our Prolieve Thermodilatation System was originally developed and commercialized by the current Medifocus management, product development, clinical and regulatory teams. In June 2012, Medifocus reached an agreement with Boston Scientific for the purchase of all of the assets of its Prolieve business, including all Prolieve inventory, the Rocky Mountain Mobile Services mobile distribution assets, as well as the intellectual property associated with the Prolieve technology.

The Prolieve system provides a 45-minute in-office treatment that combines our microwave thermotherapy capability with a proprietary balloon compression technology to both heat the prostate and dilate the prostatic urethra. The purpose of the Prolieve system is to provide a relatively painless and effective alternative to drug therapy and certain types of surgical procedures to treat the symptoms of BPH.

The Prolieve system consists of a microwave generator and conductors and a computer and software programs that control the focusing and application of heat, plus a specially designed balloon catheter, and consists of two fundamental elements:

The combined effect of this “heat plus compression” therapy is twofold: first, the heat denatures the proteins in the wall of the urethra, causing a stiffening of the opening created by the inflated balloon, forming a biological stent. Second, the heat serves effectively to kill off prostate cells outside the wall of the urethra, thereby creating sufficient space for the enlarged natural opening. In addition, the Prolieve system’s temperature (46ºC to 54ºC) is sufficient to kill prostatic cells surrounding the urethra wall, thereby creating space for the enlargement of the urethra opening. However, the relatively low temperature is not sufficient to cause swelling in the urethra.

The Prolieve is designed with patients’ needs and comfort in mind. Clinical studies have shown that Prolieve treatment can be done with topical sedation only and does not require post-treatment cauterization in 95% of the cases. BPH patients can be treated using Prolieve in urologic offices throughout the United States. In addition, the Prolieve treatment is also made available to physicians utilizing our nationwide mobile service provider, Rocky Mountain Mobile Services.

Medifocus’ strategy to capitalize on the proprietary Prolieve Thermodilatation platform is to generate revenues through our mobile service and the sale of our disposal catheter kits. Our Management believes, over time, Prolieve Thermodilatation will be the leading in-office therapy for treatment of BPH symptoms.

For more information, please watch the video “What to Expect from Prolieve.”

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Figure 1: This is a schematic illustration of a cross section of a prostate BEFORE treatment with the Prolieve System.

Figure 2: This is a schematic illustration of a cross-section of a prostate immediately AFTER treatment with the Prolieve System.

Figure 3: This is a schematic illustration of the Prolieve BPH treatment device.

To see how much reimbursement you will get for using Prolieve BPH Treatment, use the code 53850 and enter your location at this site.