In January of 1997, the FDA in the USA approved an intraurethral delivery system, MUSE, for the treatment of Erectile Dysfunction. This involves delivery of a pellet of the drug, alprostadil, into the distal penile urethra using a plastic applicator. The pellet is held in the urethra for several minutes until it dissolves and is absorbed into the erectile tissue producing an erection.
Success rates with this treatment are in the 30 to 50% range. Side effects of urethral burning and pain occur in 7 to 10% of men. While not nearly as popular as oral drug therapy, the intraurethral
route of administration of alprostadil is the preferred treatment method in a small percentage of couples.
EXTERNAL VACUUM THERAPY
This is the simplest, non-surgical drug-free method of producing a quality erection. The external vacuum device was invented by Geddings Osbon in the early 1960’s to solve his own Erectile Dysfunction problem. He created the ErecAid® System, based on vacuum pressure and tension rings, to produce and maintain a naturally engorged erection every time one was needed.
The vacuum system consists of a clear plastic cylinder, a manual pump or battery pump, and a special tension ring. The user loads a tension ring around the open end of the cylinder, then inserts his penis into that end. Holding the device firmly against the body to form an air-tight 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 engorges the penis in a similar manner 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 pushed off the cylinder on to the base of the penis. Once the vacuum is released by the patient, the cylinder and pump can be removed and laid aside. The user can maintain an erection for up to 30 minutes, wearing only the tension ring. This procedure takes two minutes or less and is used whenever an erection is needed.
The ErecAid System has been effective for over 90% of couples who have used it. Patients who have had their prostate removed use it successfully. Men who have had penile implants and later removed
can use this system successfully, as well as men with blood vessel blockages and venous leaks. Psychological patients are successful with it as well as men with diabetes.
Timm Medical Inc., the manufacturer of the ErecAid System, has polled over 200,000 couples to determine the effectiveness of the product. When questioned about the 6-month period just prior to acquiring the vacuum system, 76% of couples reported that they had no sexual intercourse or very irregular sexual activity. After using the system for ninety days, 80% said they were having sexual intercourse at least twice a month. Initially, it takes practice to learn how to use the system. Forty-two percent of patients learn how to use it in a day and 90% master the technique in two weeks. Sixty-nine percent can create an erection suitable for intercourse within two minutes.
An unexpected statistic, which emerged from the survey, pertained to the occasional restoration of natural erections.
The most significant advantage of the ErecAid system is that it works without requiring foreign drugs, surgery or a healing period. It is non-invasive, is used on the body (not in the body), and can stay in
a dresser drawer or on a shelf when not in use.
Another important advantage is cost. The ErecAid System, at $450 - $761, has the lowest cost of any treatment option. Most other Erectile Dysfunction treatments are far more expensive. The majorcomponents of ErecAid System have lifetime guarantees and medical insurance coverage is available in many cases.
A significant advantage for both partners is that the erections are of high quality, lasting longer than natural ones and they do not usually disappear after orgasm. Also, once the erection technique has been learned, the patient can achieve reliable, consistent erections each time. The erection disappears when the tension ring is removed. It is recommended that the ring be removed within 30 minutes.
With some patients, minor side effects can occur such as petechiae (pinpoint-size red dots caused by negative pressure applied too quickly) and ecchymosis (bruising caused by prolonged vacuum pressure). Neither condition is painful or serious and does not need treatment. These conditions stop occurring after a few uses with the system.
A final side effect is a temperature drop of 1-2° in the penis, which is caused by the tension ring. No major injuries have ever been reported by users of the ErecAid System.
This device may not be an appropriate treatment for men who have sickle cell anemia or a history of
spontaneous priapisms. Men on blood thinners like coumadin may safely use the device by pumping more slowly. Proper use of it requires minimal manual dexterity and hand strength.
In 1972, doctors began doing penile implants to help patients with lost potency. Since then, implants have been used by surgeons to treat about 25,000 patients per year. During surgery,two synthetic cylinders are placed inside the corpora cavernosa of the penis. After 4-6 weeks, the couple can engage in sexual intercourse.
These devices are mechanical, inflatable, or hydraulic. Their implementation permanently alters the corpora cavernosa, ending all hope of the return of natural erections, so this treatment should be
considered a final step by the couple, not an early one. There is also the risk of infection with surgical procedures, and eventual malfunction or deterioration of the device may require other surgeries.
A skilled urologist, using general anesthesia, implants this device for a total cost of $12,000 to $15,000. After 4-6 weeks of healing, the patient may begin to use it. Mechanical failure or patient infections are the two most common complications. Both can cause a need for more surgery. Key factors are (1) the surgical procedure is not reversible, and (2) the erection stems from saline solution, not the bloodstream.
VASCULAR RECONSTUCTIVE SURGERY
Penile surgery of this type is like heart bypass surgery, which reroutes the blood supply around blockages. Less than one percent of impotent men are candidates for this procedure, and the
failure rate is very high.
Venous ligation is a penile surgical procedure in which the surgeon attempts to repair the veins causing the venous leak. This procedure was popular until doctors began to realize that it
offered only a temporary solution – many patients required another operation within a few years.
These procedures cost about $15,000 to $20,000 and should only be performed by surgeons experienced with the procedures, preferably in an investigational setting. Complications may include permanent numbness near the incision and scar tissue, which may shorten or “torque” the penis. In addition, the surgery may need to be repeated.
A severe deficiency of the male hormone, testosterone, can cause Erectile Dysfunction. 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 treatment. The nature of the treatment is to give the man an injection of testosterone into the arm or the 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, and especially prostate cancer should avoid supplemental testosterone.
WHICH TREATMENTS SHOULD WE CHOOSE?
The couple must consider several factors in selecting a treatment. A few of them have been outlined below.
Partner’s opinion. Ask your partner to look at this web site with you. Ask your partner to visit the doctor with you. Does your partner lean toward one treatment more than others? If you are young with no partner, you may be happier with implants and injections.
Frequency of sexual activity. Will sex be performed twice a week, twice a month, or twice a year? Select a therapy that is consistent with the estimated amount of use.
Treatment Sequence. The best way to look at Erectile dysfunction therapy is that the simple, inexpensive, reversible treatments should be tried first, while the more complex, expensive, non-reversible treatments should be attempted later. The ErecAid system, Viagra or hormone therapy might be tried earliest since all are relatively inexpensive and reversible. Injections are next on the list, followed by intraurethral pharmacotherapy, implants and finally vascular surgery. All of these are invasive therapies that cause internal changes to the penis.
What are the odds of re-operation? Ask your doctor 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.
Financial considerations. What is the out-of-pocket cost of thetreatment 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, Viagra has an ongoing cost, as do penile injections; whereas there is minimal on-going cost associated with the ErecAid System (tension rings and lubricant).
Safe and effective treatment? Has the chosen therapy received TGA/FDA marketing approval? Have clinical studies been performed for this treatment? Does a reputable provider with liability insurance back the treatment?