Thursday, November 2, 2006

Treatment For Erectile Dysfunction

Treatment Options
Successful erections require the coordinated actions of a healthy brain, pliable blood vessels, fully functional nerves and certain hormones. Erotic or manual stimulation, triggered by the five senses or by memory, begins the erectile process. The nervous system responds by sending chemical messages to and from the pelvic area.

These messages cause the smooth muscle tissue inside the penis to relax. The blood vessels dilate, allowing more blood to flow into the corpora cavernosa, the two erectile bodies within the penis.

Like sponges, they capture more blood, swelling and lengthening the penis. When all of the spaces are occupied with blood, the organ becomes rigid. The enlarged corpora cavernosa take up so much space inside the penis that strong pressure is exerted against the penile veins, greatly reducing the outflow of blood, which allows the penis to stay rigid.

At this point, the erect penis contains seven to eight times more blood than the same flaccid, or non-erect, penis. As long as the sexual stimulation is continued, an erect stage can be maintained until orgasm and ejaculation.

Some patients can achieve an erection naturally, but cannot maintain it long enough for normal sexual activity. This situation is sometimes referred to as "venous leak." A non-invasive, prescription product called StayErec may be able to help with venous leak.

It is your doctor's job to help you determine what is causing your problem and which treatment option is best for you. All physicians will first record your medical history, including psychological and sexual aspects. They may ask about stress and fatigue and about the relationship between you and your partner. Some questions may be very personal, but your doctor needs to know about your present sexual functioning in order to treat your impotence. So, be honest with your answers.

One common question is, "Do you wake up in the morning with an erection?" If you always wake up with an erection, your physical system works, and the impotence may be psychological. If you never wake up with an erection, it suggests a physical problem with blood vessels or nerves.

A new impotence screening device called Inform(TM) is a simple, inexpensive, at-home erection test. Inform provides an easy, cost-effective method of determining whether your impotence is physical or psychological. Your doctor may use the information provided by Inform to decide on further testing with a more sophisticated testing device, the RigiScan monitor. For more information on ordering the Inform nighttime erection test, see our on-line Inform order form or call Osbon Medical Systems’ Customer Service department at 1-800-438-8592.

Whether you start treatment with your family doctor or a urologist, the initial approach will probably be conservative. Conservative, non-surgical treatments for impotence have proven very successful, and most patients find surgical treatment unnecessary.

If your family doctor is not comfortable with treating impotence, he or she may refer you to a urologist, who may prescribe any of the known treatments for impotence. He or she may also do all the examining and testing already mentioned, if not done by your family doctor. The urologist will conduct additional, more sophisticated tests if you are thinking about a surgical correction for your impotence.

A panel of experts met in Washington, D.C. in December 1992 to assess current knowledge of the diagnosis and treatment of impotence. They recommended that "as a general rule, the least invasive treatments should be tried first." The statement of the National Institutes of Health (NIH) Consensus Panel suggested the staging of treatments from the least to most invasive in a sequence such as the following:

External vacuum devices (ErecAid® System)
Penile injection therapy (InjecAid System)
Penile implant surgery (Dura-II)
Vascular surgery

Sexual therapy or counseling - In November of 1996, the American Urological Association (AUA) issued the first official guidelines for the treatment of erectile dysfunction. The guidelines confirm and reinforce the NIH recommendations on the staging of impotence treatment, adding that the three safe and effective treatments today are external vacuum therapy, penile injection therapy and implant surgery. The guidelines further declare that vacuum therapy is almost always helpful as an adjunct therapy and may be used concurrently with any treatment.

Some men may be helped by taking an oral drug like yohimbine, but its effects have been determined to be largely placebo effects and any results are usually weeks away. A small percentage may also benefit from taking hormone medications, but unless the hormone deficiency is severe, this treatment may not help.

Vacuum therapy with ErecAid® System, the original external vacuum device, is probably the most widely recognized first-step treatment since it works for all types of impotence and has minimal side effects. Even if other non-invasive treatments like yohimbine or counseling are tried first, vacuum treatment can be applied concurrently to get immediate results. Vacuum therapy is widely prescribed, safe and 90% effective.

Penile injections have been used for over a decade with about a 70% success rate, but many men reject this treatment when they learn that it involves putting a needle into the penis. However, many impotence clinics specialize in this common, effective therapy. More recently developed is a method of delivering a drug through insertion of a pellet into the urethra

Implanted devices, of course, involve surgery. Experts now believe that this treatment, once considered the "gold standard" therapy, should only be done as a last resort, if and when less invasive treatments have failed. The placement of an implant permanently alters the interior structure of the penis and precludes successful use of other therapies or the return of natural function. Consider that when a pill is finally discovered to restore potency, it will surely require healthy corpora cavernosa in order to work.

External Vacuum Therapy - This treatment is a simple, non-invasive method of producing a quality erection. The external vacuum device was created by Geddings Osbon in the early 1960s to solve his own impotence problem. He created the ErecAid® System, based on negative pressure and tension, to achieve and maintain a near-natural erection any time one was desired.

ErecAid® System consists of a clear plastic cylinder, a manual pump or battery pump and a patented pressure-point tension ring. The user loads the tension ring around the open end of the cylinder, then inserts his penis into that end. Holding the device firmly against his body to form an airtight seal, he uses the pump to remove air from inside the cylinder. This creates a partial vacuum around the penis, causing the body’s blood to enter the corpora cavernosa. This fills the penis with blood in a way similar to a natural erection.

To maintain the erection, it is necessary to reduce the outflow of blood from the penis. Therefore, while the penis is still under vacuum pressure, the tension ring is moved from the cylinder onto the base of the penis. The cylinder and pump are then removed and laid aside. The user can maintain an erection for up to 30 minutes wearing only the tension ring. This method of creating an erection takes about two minutes and may be used as often as desired.

ErecAid® System has consistently proven effective for over 90% of its 450,000 users, regardless of the cause or origin of their impotence. It is often prescribed following prostate surgery and has even been successfully used by men who have had a penile implant removed. Also, because of its non-invasive nature, ErecAid® System may be used as an adjunct to other therapies.

One of the most significant advantages of the ErecAid® System is that it works immediately, without requiring surgery or a healing period. The erections are of high quality, last longer than natural ones and do not usually disappear after orgasm. Though it is recommended that the ring be removed within 30 minutes. Also, once the Osbon Technique has been learned, the patient can achieve reliable, consistent erections whenever he wishes.

Another advantage is cost. The ErecAid® System has a one time cost of $400 to $500. Most other impotence treatments have a continuing cost for duration of use. Medicare and most private insurers cover the cost of ErecAid® System. To further protect you, the major components of ErecAid® System have lifetime replacement guarantees.

Side effects of vacuum therapy are minor and rarely require treatment. Some men experience petechiae and ecchymosis. Reddish pinpoint-size dots (petechiae) may appear on the surface of the penis. They are often caused by placing the penis under negative pressure too rapidly. Ecchymosis is a bruise caused by the penis being held under vacuum pressure too long. Neither condition is painful or serious and does not need treatment. They stop happening after a few uses. No major injuries have ever been reported by users of the ErecAid® System, and side effects rarely require treatment.

This device may not be an appropriate treatment for men who have sickle cell anemia or a history of spontaneous priapism (extended erections). It has been determined that men on blood thinners like coumadin may safely use the device by pumping more slowly. Proper use of ErecAid® System requires some manual dexterity and hand strength though the newer battery powered model minimizes that requirement.

Some of the drawbacks mentioned by users involve the initial minor discomfort of the tension ring or a perceived loss of spontaneity in lovemaking. Both of these concerns appear to resolve with regular use of the device. Becoming comfortable with ErecAid® System is comparable to becoming comfortable with eyeglasses or a hearing aid during the first few weeks of use. Most couples believe that the learning period is well worth the effort for the return of a fuller, happier life. For more information on the ErecAid® System, please call or e-mail the Osbon Medical Systems’ Customer Service department at 1-800-435-6780.

Penile Injection Therapy - Self injection should be done near the base of the penis and at a specific angle. Physicians learned in the early 1980s that some medications injected directly into the corpora cavernosa would produce an erection within a few minutes. Urologists now routinely use this method to treat men by teaching them self-injection techniques to use at home.

Currently three medications are used for penile injection, though only one - Prostaglandin E¹ (alprostadil) - has received permission to market under FDA guidelines. The first injections were typically of papaverine alone; the alpha blocker phenlatahine was sometimes added to papaverine as well as prostaglandin E¹.

Diabetic needles (27 or 28 gauge, a half-inch long) are used for these injections. The patient must learn to inject the base of the penis at a specific angle, usually using less than 1 cc. Either corpus cavernosum may be injected but not the urethra. Hand pressure is applied afterward to the injection site for 2-3 minutes to prevent bleeding. Ideally, erections will last 30-60 minutes and will become more rigid if stimulation occurs.

With injection treatment, high quality erections are available on demand, and they last longer than natural ones. The erection does not always disappear at orgasm or ejaculation. Injections work in about 70% of all cases. The 30% failure is often due to poor blood flow, venous leakage or severe scarring of the penile tissues.

There are concerns with injections. The key ones are priapism, pain, dropout rate, and cost. "Priapism" is an unwanted, prolonged erection. Injecting too much of the drug may cause an erection which lasts much longer than intended. After four hours, men should seek medical help for reversal of the erection. This is done by injecting an adrenaline-like drug into the penis.

Any pain from injecting is primarily from the needle puncture. Many men are frightened to think of injecting the penis with a needle, though the needless are a very fine gauge and many report the injection to be painless. This apprehension may account for the high dropout rate for men on injections. A 1990 study (University of Chicago) showed that 51% of the group dropped out after receiving only a test injection. The average patient stayed in the study group for seven months before leaving it. Other men, however, have injected successfully for years.

Depending on the exact mix of the drugs, one injection will cost from about $5 to $32. If a man is sexually active twice a week, the annual cost will range from $520 to $2080. Reimbursement is available for prostaglandin drugs only.

Implant Therapy - In 1972-73, physicians began doing penile implants to help with lost potency. Today, surgeons implant about 20,000 of these devices per year into American men who choose this treatment. Semi-rigid rods account for about 30%; multi-component inflatable implants are thought to be 50% of the total; and self-contained devices make up the last 20%. In all cases, two synthetic cylinders are surgically placed inside the corpus cavernosum of the penis. After a 4-6 week healing period, a man is usually ready to engage in sexual intercourse.

These devices are either mechanical, inflatable, or hydraulic. Their implementation permanently alters the corpora cavernosa, ending the possibility of the return of natural erections, so this treatment should be considered a final step, not an early one. All surgery carries a risk of infection and eventual malfunction or deterioration of the device may require other surgeries.

Semi-Rigid Rods (Penile Prosthesis or Dura-II) - A pair of semi-rigid rods implanted in the penis is bendable. Two bendable rods have an outer coating of silicone and inner, parallel, silver or stainless steel wires or interlocking plastic joints held together by a cable. With this rod, the penis is always erect, but can be bent down. To prepare for intercourse, the man simply bends the penis to a "ready" angle.

The rate of complication is low and many of these rods are inserted as an outpatient procedure with a local anesthetic. The surgeon’s skill is important since he has to properly "size" the implant to your penis. Cost is approximately $6,000-$10,000, including the surgery.

Disadvantages are: Because the penis is always erect, it is difficult to hide under a swimsuit or tight-fitting clothes; the erection is due to metal and silicone, not the flow of blood into the penis; and, finally, the surgery is not reversible.

Multi-Component Inflatable Implants - This implant has two or three components. Inflatable cylinders are placed in the corpora, a fluid reservoir goes into the abdomen (or scrotum) and the pump is placed in the scrotum. Squeezing on the pump moves fluid from reservoir to cylinders, causing rigidity. A squeeze of the pump release valve reverses this process.

Self-Contained Inflatable Implants - Two cylinders are placed inside the penis. Each one contains a pump, fluid, and release valve. A squeeze of the head of the penis forces a fluid transfer to the forward chamber, causing rigidity. A simple bend of the penis causes fluid to flow back into the storage area, ending the erection.

Vascular Reconstructive Surgery - Penile surgery of this type is similar to heart bypass surgery, which reroutes the blood supply around blockages. Fewer than 1% of impotent men are candidates for this procedure, which is still considered experimental. The failure rate is high.

Venous ligation is a penile surgical procedure in which the surgeon attempts to repair the veins causing venous leak. This procedure was popular until physicians began to realize that it offered only a temporary solution, as many patients required another operation within a few years.

These surgeries cost about $15,000-$20,000 and should only be performed by surgeons experienced with the procedures, preferably in an investigations setting. Complications may include permanent numbness near the incision and scar tissue which may shorten or "torque" the penis. Also, the surgery may need to be repeated.

What are the odds of re-operation?
Ask your physician about the odds of having repeat surgeries. Ask about the failure rate of the implant he is recommending. Ask about the failure rate of the various vascular surgeries.

Hormone Medication - A serious deficiency of the male hormone, testosterone, can cause impotence. In these situations, treatment with hormone replacement can be effective. Only about 3-4% of the male population, however, has this problem and can benefit from the treatment.

The nature of the treatment is to administer an injection of testosterone into the arm or buttocks to raise the hormone to acceptable levels. Side effects of testosterone replacement therapy can be serious, and patients with a medical history that includes liver disease, heart disease, kidney problems or, especially, prostate cancer should avoid supplemental testosterone.

Yohimbine Tablets - This natural aphrodisiac from the bark of the yohimbehe tree is sometimes prescribed by doctors for men with intermittent erectile dysfunction. In most of these cases, the physician suspects a psychological problem, but cannot prove it. The drug is used to stimulate desire and improve the quality of the erection. Dispensed in tablet form and available only by prescription, yohimbine is taken three times a day for 4-6 weeks to test its effect. Costs are
about $40 a month. Even if the tablets work (which they do in 15-20% of patients) stopping the tablets may return the patient to his former state of impotence. Side effects may include headaches, sweaty palms, dizziness, and nausea. Men with ulcers or hypertension should take this drug with caution. The American Urology Association has determined that the benefit is largely a placebo effect.

Sex Counseling and Sex Therapy - Sex counseling refers to consultations with a qualified counselor who helps the couple to identify, understand and cope with their sexual concerns. Sex therapy is more structured in that it uses counseling, but also includes a time element and specific exercises for the couple. Exercises are meant to remove stress from areas of the relationship that influence sexual function. They may include sexual touching and other sexual exploration.

When the cause of impotence has a strong psychological involvement, sex counseling or therapy can be very effective. Many people feel that counseling can enhance the effects of other treatments as well. Couples should seek this therapy only from a trained professional with a good reputation. Best results occur when there is good partner cooperation and both patient and partner attend the counseling session.

Which Treatment Should I Choose?
You and your partner should thoroughly discuss the options and your habits. Go through this booklet together and visit the doctor together. Does your partner lean toward one treatment more than the others? Do you? Start with the simplest treatment that has the highest potential for success.

Treatment Sequence.
The best way to look at impotence therapy is that the simple, inexpensive, reversible treatments should be tried first, while the more complex, expensive, non-reversible treatments should be attempted later. ErecAid® System, yohimbine tablets, and sex therapy might be tried earliest since all are relatively inexpensive and reversible. Injections are next on the list, followed by implant surgery. The surgical procedures are the most invasive therapies and cause internal changes in the penis. If some new treatment appears in the future which requires the corpora cavernosa to be healthy, you may miss out on it if you have permanently altered the erectile bodies.

Financial considerations.
What is the out-of-pocket cost of the treatment selected? How much will health insurance pay for? What are the guarantees or warranties of the treatment chosen?

Maintenance costs. Ongoing costs for treatment must be identified. For example, yohimbine tablets have an ongoing cost, as do penile injections.

Safety and effectiveness.
Has the chosen therapy received FDA marketing approval? Have clinical studies been performed for this treatment? Is the treatment backed up by a reputable provider, with liability insurance?

Treatment Alert!
Unfortunately, perhaps due to the private nature of impotence, unethical advertising of sexual help products and miracle "cures" abounds. Many men do not seek medical treatment, but attempt instead to treat themselves with non-medical devices or unproved remedies. These so-called "cures" seldom work and can be potentially harmful.

Also, because impotence is often a symptom of more serious physical problems such as vascular disease or diabetes, it is extremely important for anyone experiencing impotence to see a qualified physician. Only after careful examination can a doctor determine the cause of impotence and recommend appropriate treatment.

Lastly, be wary of clinics that promote unnecessary and/or expensive testing when trying to determine the cause of impotence. Usually a detailed medical and sexual history will reveal a patient's predisposition to common, primary causes of impotence, such as diabetes.

Insurance Coverage - Insurance companies will generally pay for impotence treatment when the cause is physical. Your physician must specify on the claim form the physical cause of your impotence and that your treatment is "medically necessary."

Medicare coverage is divided into Medicare A, which covers surgeries, hospital stays and the more costly medical services; and Medicare B, which covers doctors’ office visits, medical devices and the less costly items and services. If you have Medicare, the person who sold you the System is required to file the claim for you. This may be your doctor, your pharmacist, medical supplier or Osbon Medical Systems. However, you are responsible for furnishing your Medicare number, date of birth, medical diagnosis, prescription and payment before a claim can be filed.

If you have FICA taxes deducted from your paycheck, you will be covered by Medicare A at no charge when you reach 65. Medicare B costs about $30 a month and may be deducted from your Social Security check.

Surgical treatments for impotence are covered by Medicare A in most states, as long as your doctor verifies a physical cause of the impotence and states that the treatment is "medically necessary." Vacuum devices are covered under Medicare B. Penile injection therapy is not covered by Medicare at this time.

With a valid prescription, you may obtain an ErecAid® System from your doctor, a pharmacy, a medical supplier or directly from Osbon Medical Systems

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