Treatment for Erectile Dysfunction
About treatment | Help with selecting the right drug for you | Other treatment options | What Works | What's New | Summary
What to Do?
Medical treatments for impotence include counseling when a psychological problem is discovered. Working with couples and reducing tension, improving communications, and trying to obtain realistic expectations are areas where counseling can help. In some patients where psychologic causes are not the originating problem, but have become a significant factor, it may be necessary to go through counseling during the difficult rehabilitation period.
Lifestyle modifications including changes in exercise, stress levels, diet, alcohol, smoking, and illicit drug use may be beneficial if felt to be a major contributing factor.
The newest and most exciting development is in pill form. The drug called sildenafil (or Viagra) has been studied in England and seems to improve erections in men who have no known cause for difficulty with erections. Studies on men with known causes, such as surgery or diabetes, have not been completed, but early data are promising. Viagra works by increasing blood flow to the penis. The drug is available now. Early studies show very few side effects. The drug does not directly cause erections, but enhance erections caused by sexual stimulation. It works by partially blocking an enzyme in the penis that is responsible for normally reversing erections. Some studies have shown 60-80% effectiveness in selected patients with difficulty maintaining erections. About 1 in 25 men discontinued therapy from side effects, which included headache, indigestion, visual disturbances, and flushing. Viagra, which comes in three different dosages, and onset of action which begins within 20-60 minutes. The effect lasts for four hours. Only one dose per day is recommended. Diabetics and men who have had radical prostate or bladder surgery have a lower success rate with Viagra.
IMPORTANT NOTE: Patients who take or need nitroglycerin or nitrates for heart disease cannot use this drug. A number of heart attacks, some causing death, have been reported since the introduction of Viagra. These appear to be due to the exertion of sexual intercourse or to the use of nitroglycerin with Viagra against doctor's orders. Patients with significant heart disease, whether using nitroglycrin or not, should be counselled about the risk of heart attack.
Hormone treatments, namely testosterone, can be used in men whose production of male hormones is low. Testosterone injections do not really help men who have high levels, and these can be measured by the physician at the initial evaluation. Testosterone injections are not without their problems, however, as the use of the drug can stimulate the growth of prostate tissue. Testosterone cannot be used in patients with known or suspected prostate cancer as the cancer could grow more rapidly. Other, less common side effects of testosterone use include liver injury and increased blood pressure. Men who take testosterone regularly usually stop sperm production, and permanent infertility could result if testosterone is used long enough.
Yohimbine is a medication made from the bark of a tree that grows in India and Africa. Yohimbine acts on the nervous system and may also have some affect on increasing the male libido. It is considered homeopathic by medical doctors, that is, no definite uses are proven. The drug is very safe with uncommon side effects such as mild dizziness, nervousness, irritability, headaches and nausea rarely occuring. Some studies have suggested 10-20% of men will respond to the treatment with yohimbine, and it is necessary to take the medication for a full two months before knowing whether it will work or not. However, a task force of specialists sponsored by the American Urological Association has recently determined that Yohimbine is no more effective than placebo.
Trazodone is an antidepressant drug that was found to induce prolonged erections in some men. This side effect was unwanted and the prolonged erections cause problems in many of the patients. However, in lower dosages, (usually 100 mg at bedtime) it can promote normal erections. Trazodone can cause drowsiness, nausea and difficulty urinating.
What is self-injection therapy?
This involves the patient or his partner giving an injection of medication directly into the side of the penis to create an erection. The erection created is a natural one and usually begins 5 to 15 minutes after the injection. Not all patients respond to this type of treatment, but those that do should develop an erection that lasts anywhere from 30 to 120 minutes. About 70% of men find that their erections are satisfactory with self-injection therapy. The injections are given with a tiny needle and use very small amounts of medicine. The injections are relatively painless and are easily taught to the patient in one or two visits with the doctor.
The drugs used today include: prostaglandin (PGE-1 or Prostin or Alpoprostadil or Caverject), Papaverine hydrochloride and phentolamine (Regitine). All of these drugs have been approved by the FDA for uses other than impotence treatment. Only Prostaglandin has been approved by the FDA for treating impotence. Papaverine and phentolamine have not yet been approved by the FDA for this specific purpose, although these two drugs were the initial ones used for self-injection therapy. However, considerable experience has been obtained by urologists over the past decade and all three drugs mentioned above are considered safe for self-injection therapy.
Disadvantages of Self Injection Treatment
Self-injection treatment does require the patient or his partner to learn to give injections directly into the penis. The patient does need to return to the doctor for follow-up visits, particularly in the early phases of treatment. The patient cannot use the injections too often for fear of developing scarring and the self-injection treatment should be limited to once every four to seven days (range depends on medication type and initial response).
The injections are relatively costly and average costs depend on what combinations of medications are used. An injection may cost up to $8 to $10 per injection.
Not all patients are candidates for self- injection therapy. A percentage of patients will not develop good erections, and another set of patients might develop erections that do not go away, making them poor candidates for continued use of this drug.
Advantages of Self Injection Treatment
The major advantage of self-injection therapy is the fact that the erection created is similar to the body's own spontaneous erections. The erection usually lasts 30 to 120 minutes, which is adequate duration for successful and pleasing intercourse. Self- injection therapy does not impede the development of an orgasm or ejaculation. Self- injection therapy is less costly than surgical implantation. Self-injection therapy can be used by the patient at his own discretion and at anytime with a minimum amount of preparation. Treatment does not involve surgery and is minimally painful in most patients.
Summary of Self Injection Therapy
If you decide to start the self-injection program, we will have you back to the office for test doses to see which drug and dosage is most appropriate and effective for you. After we have established the drug dose, we will then teach you how to draw medication from a vial, and also how to inject it safely into the penis. You may want to bring a partner to watch, although a partner is not absolutely necessary if you have good dexterity and eyesight. We will have you read, understand and sign a consent form. The form will mention the various risks of the medications and injections. We will go over all of these risks and conditions for you in detail at the time of the educational program. If you have any questions about self-injection therapy, please don't hesitate to ask us.
As mentioned, these medications have not been approved by the FDA and so technically need to be considered experimental. All medications have some potential risks and side effects and risks do exist with all of these drugs and the injections. These may include the possibility of bleeding or bruising from the injection, and a small chance of infection. One of the more common risks include the development of a prolonged erection or priapism (more than four hours). An episode of priapism might require a trip back to the physician or to the emergency room to receive other medications to counteract the self-injection medications and relieve the prolonged erection. Priapism happens in only a few percent of the patients. The patient does need to be aware that any erection lasting more than four hours need to be dealt with by a physician. Another complication is the development of permanent scarring within the penis. The medications can be irritating to the penile tissues, and scarring is most often seen in patients who abuse the drug by using it too often. Scarring could create difficulty obtaining erections even with additional medication. If the scarring were severe, placement of a penile prosthesis, if that other option was chosen at a later time, might be difficult. Even rarer is the development of other medical problems. Papervine has been known to cause changes in liver function tests which go away if the drug is stopped. Some men complain of dizziness, heart palpitations and/or a flushed feeling with these medications.
About Erectile Dysfunction Drugs: Which one is right for you?
In 1998, the FDA approved Pfizer's drug Viagra for the treatment of ED. There has been over one billion pills sold world wide to over 23 million men, over 600,000 physicians have prescribed the drug and one prescription is written every 4 seconds. As a result the drug has become the second most common trade name in the world just behind Coke but ahead of General Motors, IBM, and Microsoft. This is also one of the most widely tested drugs with more than 130 studies in more than 13,000 experimental patients. There have been more than 2000 articles written on the safety of the drug in heart patients and in men with hypertension making it one of the scrutinized drugs every brought to market. The drug is also a financial success for Pfizer with sales of over $1 billion annually for this pill that sells for about $9 in local pharmacies.
Now there are two new drugs that are available for the 30 million American men who suffer from ED. Levitra (Bayer-Glaxo, Smith, Klein) and Cialis (Lilly-ICOS). Each drug maker is touting the benefits and features of their drug leading to potential confusion for men who suffer from ED.
How to select a drug for ED?
First the efficacy or the success of the drugs are all about 75-80%. No one drug maker can boast better results of their drug over that of the competitor's product. In difficult to treat patients, such as men with diabetes or in men who have had surgery for prostate cancer, all three drugs are less effective. The results in these patient populations is 50-60% for all of the ED drugs.
The onset of action is another area of comparison. Most of other drugs work in 10-30 minutes, although Levitra reports a faster onset of action than Viagra or Cialis.
With or without food?
Viagra appears to work best if not taken with a heavy meal, especially a meal high in fat content. Levitra's onset of action is slightly delayed with high fat meals and Cialis does not seem to be affected by food consumption.
All three drugs are effective with minimal to moderate amounts of alcohol. All three drugs have decreased performance with excessive alcohol consumption. Who wants to have sex when you are passed out from imbibing too many "ritas" or more vodka than tonic?
All three drugs are absolutely contraindicated in men using nitrates for angina and chest pain. The nitrates and the ED drugs can reduce the blood pressure to such a low level that the blood supply to the heart is also affected and result in serious heart complications. However, if a man is able to walk up two flights of stairs without shortness of breath or without chest pain, then it is perfectly safe for him to engage in sexual intimacy. (Just ask Jack Nicholson in "Something Got To Give" when he asked his doctor about returning to sex after suffering from a heart attack.)
ED drugs and alpha blockers.
Levitra is contraindicated in men using any alpha blocker, i.e., Cardura, Hytrin, and Flomax, for the treatment of benign prostate enlargement. Cialis is to be avoided with the use of Cardura and Hytrin but not with the lowest dose of Flomax, or 0.4mg. Viagra is not to be used within four hours of using any of the alpha-blockers. So, if you have sex in the morning and use Viagra, take the alpha blockers in the evening and visa verse for those who prefer their sex when the sun goes down.
Levitra and Viagra have a duration of 8 hours. Cialis, however, is effective for 36 hours thus allowing more spontaneity in the sex act than the other two drugs. Perhaps that is why Cialis is referred to as Le Weekender!
The side effect profiles of the three drugs are also similar. They all cause mild nasal congestion, flushing or redness of the face, and occasional headaches. Cialis can cause temporary low back pain in a small number of men which subsides in a few hours. It is of interest that only 2-3% of men will stop using the three ED drugs because of these adverse events.
MUSE is the name of a drug treatment and represents a unique approach for the treatment of erectile dysfunction. It is based on the discovery that the urethra (the tube in the penis for urine to pass from the bladder to the outside of the body) can absorb certain medications into the surrounding erectile tissues thereby creating an erection. The MUSE system uses prostaglandin E1, the same medication used in the self injection therapy, and has been approved by the FDA for the treatment of impotence.
An erection should begin within 5-10 minutes after administering MUSE. The duration of effect is approximately 30-60 minutes. However, the actual duration will vary from patient to patient.
The most common side effects that have been reported using MUSE are aching in the penis, testicles, legs and in the area between the scrotum and the rectum, warmth or burning sensation in the urethra, redness of the penis due to increased blood flow, and minor urethral bleeding or spotting due to improper administration
MUSE was released in early 1997 and more experience will be gained over the first few years that it is available to the public through their physicians. It is likely that MUSE will not be as effective as the self-injection therapy because of the variability of absorption of the medication and will most definitely be more expensive. The absence of needles however makes this form of therapy very attractive for those men in whom the treatment works.
The vacuum erection device is a simple mechanical tool, which allows the man to develop an erection which is suitable for sexual intercourse.
Why do Vacuum Erection Devices Work?
Erections are created when blood in trapped in the penis much like air is trapped in an inflated tire. The more air that is placed into the tire, the firmer the tire becomes. Likewise, the more blood trapped temporarily in the penis, the firmer the erection. The vacuum erection device works by bringing more blood into the penis and then trapping it.
How Does Vacuum Erection Devices Work?
The penis is inserted into a hollow plastic tube, which is pressed against the body creating a seal. A vacuum is then created in the tube by use of a small hand pump. This in turn draws blood into the penis causing engorgement, enlargement and rigidity. After one to three minutes of vacuum, an adequate erection is created and a soft rubber O-ring is then placed around the base of the penis in order to trap the blood and maintain the erection. The vacuum tube is removed and sexual intercourse is then possible. The rubber O-ring will maintain the erection until removed, and in most circumstances this can be left in place for 25 to 30 minutes.
Who are the Best Candidates for Vacuum Erection Devices?
Vacuum erection devices work best in patients who are able to achieve a partial erection on their own. After having adequate foreplay, which creates a mild erection, the partner can be of help in applying and using the vacuum device. In any type of sex therapy, the partner's full acceptance of whatever technique used is always helpful.
One of the major advantages of vacuum erection devices is safety. There is no surgery, internal injections or significant side effects. The vacuum erection device will work for almost any type of erectile problem. The cost of the vacuum erection device is less than surgery or the continued use of self-injection treatments. The vacuum device can be used at the patient's convenience and at any time. Most of the major companies that manufacture vacuum erection devices provide a refund policy if the vacuum erection device is not successful. The vacuum erection devices range in cost from $300 to $500 and require a prescription. Some insurance companies will reimburse all or part of the costs.
One of the disadvantages of the vacuum erection device is the mechanical aspect of obtaining an adequate erection. This might have a negative influence on the patient and his partner. The device takes 5 to 10 minutes to set up, which technically interferes with foreplay. Some patient's body build makes it difficult to apply the vacuum erection device. Once the rubber O-ring is applied, there is not an erection between the rubber band and the body, making the penis somewhat floppy.
The O-ring inhibits the normal flow or ejaculation after orgasm in some patients. This is not harmful and the semen will pass once the rubber band is removed. Some patients complain of a sense of coldness and/or numbness of the penis after the O-ring has been placed. The O-ring should be removed after 25 to 30 minutes because of restricted blood flow. The erection will soften when the O-ring is removed. Vacuum erection devices might be harmful to patients who have blood clotting problems or use blood thinners because of bleeding into the tissue.
If you have any questions about vacuum erection devices, please don't hesitate to ask us. We have videotapes available for further information about vacuum erection devices, and you need only to borrow a tape or come into the office to view it.
Implantation of a penile prosthesis is one of several options available for the treatment of impotence. The penis consists of three hollow tubes running along the length of the shaft. One of these, the urethra, runs along the bottom of the penis and brings urine from the bladder out through the end of the penis. The other two matched tubes running side by side on the top of the penis are constructed much like an automobile tire with an outer tube and an inner tube. The erection is created by the two inner tubes filling and pushing against the outer tubes much like a tire that is inflated with air.
One of the treatment options for erectile dysfunction is the placement of prosthetic inner tubes within the penis to mimic the inflation process and create an erection. Penile implants were first used in the 1950s, and as time went on further advances occurred. Different types of prostheses were developed and hundreds of thousands of men throughout the world have been successfully treated with a penile implant.
Today there are three types of penile prostheses. These include the semirigid implant, the inflatable implant and a self-contained inflatable implant.
Semirigid implants are paired silicone-covered malleable or bendable metal rods. The semirigid prosthesis allows the penis to be rigid enough for penetration, but the malleable rods allow it to be flexible enough to allow concealment in a curved position. It is the simplest of all prostheses and has the least chance of mechanical failure. It is also the simplest to place.
The major limitations include the fact that the penis is always semi-erect. Even with the bendability, concealment is a potential problem when wearing some types of clothing. Another disadvantage is that the prosthesis does not inflate so the erection achieved is only from the size and rigidity of the prosthesis.
Inflatable Penile Prostheses
Inflatable prostheses are the most natural of the implants. These are soft paired inner tubes made of silicone or bioflex, which are inert plastics. The inner tubes are literally filled with a solution that comes from a small reservoir placed under the muscles of the abdomen. A pump is used to transfer the fluid from the reservoir to the penile cylinders or inner tubes. The more fluid that is pumped into the inner tubes, the firmer and larger the erection. When the erection is no longer desired, the fluid returns to the reservoir leaving the penis soft and pliable.
The major advantages of inflatable penile implant are a more natural erection with total patient control, both in the amount of fluid that is put into the penis, as well as the time the erection is desired. The erection will last indefinitely until the patient transfers the fluid back into the reservoir. One major disadvantage is that the surgical implantation is a little more complicated than a simple semirigid implant. Also, with the multiple parts there is a higher chance of mechanical failure which might require revision or repair. 9Many of the companies do have insurance policies to cover part or all of the costs of the prosthesis replacement but not the surgical or hospital fees.)
Self Contained Inflatable Prostheses
Self-contained inflatable implants are paired silicone cylinders which have a pump at the very tip of the prosthesis, along with a reservoir within the shaft that transfers fluid in such a way that the cylinder becomes firm.
The advantage of this type of prosthesis is that the surgery is somewhat simpler than the multi-component prosthesis.
The major disadvantage is that the inflatable portion of it does not really increase the girth of the penis significantly. It is also not as soft or concealable as the multicomponent implant when deflated.
Advantages of Implants
Implants are effective in treating impotence due to almost every cause. There is a 90%+ success rate when both partners are informed of the nature and limitations of the prosthesis. Prostheses require no further treatment after implantation, and there is no external equipment which might have negative connotations to the partner. No medications or injections are needed and once the prosthesis is placed and functioning, there are no further costs. The newer prostheses are very reliable and the chance of mechanical failure is very low, in the range of two to four percent per year.
Disadvantages of Implants
Once an implant has been placed, natural erections usually no longer occur. If the prostheses were then removed the normal erections are unlikely to return. There is a small chance of infection which would require removal of the prosthesis. Some patients can develop surgical complications or anesthetic complications. Occasionally patients will notice numbness at the head of their penis and intercourse can be uncomfortable. Because the erection is not caused by increased blood flow to the penis, the head of the penis is not part of the erection, and this softness may be bothersome to some patients.
Recently the safety of silicone and silicone products such as silastic have been questioned. Breast prostheses using liquid or gel forms of silicone were removed from the market by the FDA. Concerns raised were the inflammatory responses to this type of silicone which included pain, scarring and disfigurement. In addition, possible associations were raised among silicone and the development of immune disorders like rheumatoid arthritis and a possible association to an increased development of cancer. It is noteworthy that the solid silicone breast implants that are filled with water were not removed from usage. In May, 1994, a class action suit was filed against the major manufacturer of penile prostheses claiming many of these same issues. The penile prostheses are all of the solid variety and use water as a filling. Most observers feel the suit to be without basis, but of course, only time will tell and more research and follow-up needs to be done. Solid silicone products are used extensively in medicine and include cardiac pacemakers and brain shunts. Thousands and thousands of implants of all types have been used for years with very little and predictable risks and side effects.
Some insurance policies will cover the cost of prostheses and this can be established through our business office. Patients who are considering a prosthesis should be aware that other types of therapy might be available, including vacuum devices and self-injection therapy.
Vascular Reconstructive Surgery
A small percentage of patients may be candidates for some form of reconstruction of the penile blood flow. This includes patients with poor arterial blood supply and those also with venous leaking. The long-term results from this type of surgery have been generally disappointing with even the best of results showing only 1 out of 20 men being helped. Surgery is technically difficult, relatively expensive, and includes complications of nerve damage and scar tissue formation. Given the relatively low success rate, along with the technical difficulty and expense of this type of procedure, vascular reconstructive surgery has not been generally accepted widely.
For many years physicians believed almost all of the sexual dysfunctions to be caused by psychologic reasons. As we have gotten a better understanding of the physiology of erections, it has become known that many of the problems with impotence are caused, in fact, by physiologic reasons that are uncontrollable by the patient. However, a significant number of men still develop erectile problems purely on the basis of psychologic causes. In addition, men with an underlying physical disorder often develop psychologic problems as well because of their lack of performance. Even if the physiologic or as physicians often say "organic" problem is corrected, the man's self-image and confidence may be affected significantly enough that return to normal functioning is difficult.
Among the problems in dealing with psychologic problems is the fact that the topic is difficult to talk about or even bring up in front of a physician. Once the lack of confidence is deeply imbedded in the man's psyche, the subsequent lack of confidence becomes very difficult to remove from the man's thinking. Other emotions that may be felt include deep frustration, anger, depression and a sense of inadequacy.
Whether the cause of the difficulty with maintaining or achieving erections is purely psychologic or secondary to another physiologic cause, the end result creates a lack of confidence which results in a "self-fulfilling prophecy". The patient is so fearful of not obtaining an erection that the worry becomes so overwhelming that fears are born out -- no erection or loss of erection.
Sex therapists are trained professionals who deal with sex problems uniquely, and are very goal oriented to provide techniques, advice and counseling on dealing with the sexual problem only. They may provide reading and videos for help in their training. Usually only a few visits will provide definite improvement, and it is usual not to require more than a few months of treatments before seeing some definite results. Other causes of stress, obtaining adequate expectations from your partner and looking at relationships are also essential to effective sexual counseling. Some of the more specific treatments include exercises or treatment plans that are carried out in the privacy of one's home and does not require in-hospital or in-office treatments. The patient's partner is definitely brought into the technique training.
Working together to reduce anxiety and increase confidence, both partners can help each other to relieve some of the anxieties and reestablish normal sexual relationships.
Sex therapy is also helpful in patients who have premature ejaculation or difficulty in obtaining an ejaculation.
In some patients the problems are so deep-seated that the pure psychologic techniques are not effective. In these cases the sex therapist might work with the physician in concert using a technique such as a vacuum erection device or self-injection therapy to aid in the early achievement of erections. As the patient's self-confidence improves, these therapies might be discarded, although they can be used in the future as well. On occasion, medications or injections of hormones can be used to also help initiate or stimulate early sexual functioning. Sex therapy is usually not covered by insurance policies, but it is unlikely that the counseling will need to continue past six months or so, which should keep the costs within most people's budgets.
Some men have had success using external support devices. The most popular of these is called Rejoyn. These devices are essentially a semi-rigid condom. They are placed over the penis and provide the necessary rigidity without the need of an erection. These can be purchased without a prescription at many pharmacies or by calling 1-800-297-9329 for more information.
What Does Work
At this point there is no evidence that nutritional supplements or vitamins have any significant bearing on sexual performance. The Food and Drug Administration has currently banned the sale or advertising of all nonprescription products for the treatment of male impotence because none had been scientifically shown to be effective. Nitroglycerin patches and minoxidil (the drug for baldness) have not been shown to be effective for impotence when used as penile patches.
Another new oral (taken by mouth) drug is apomorphine. This drug also seems to promote erections in men with psychogenic problems Apomorphine may also work in men having difficulty maintaining erections. Large studies are currently underway in the US to determine the safety and effectiveness of these drugs. We do not expect release of this drug until late 1998.
Yet another oral drug is Vasomax (phentolamine). This medicine is still being tested and does not seem to have the effectiveness of Viagra with a 40% response in men tested. At higher doses, a lowering of blood pressure may be problematic.
All of the oral drugs have different modes of action and if one does not work, the others may. Combinations of drugs, (e.g. Viagra and ?) and other techniques may also be possible.
In recent European studies, a new injectable drug called VIP is being tested. VIP stands for vasoactive intestinal peptide. When mixed with phentolomine (Regitine), an older injectable drug, 80% of men had successful erections, even if they had failed other injectables. Studies are just beginning in the US.
Two other injectables being researched abroad are called moxislyte and forskolin Initial success rates of 80% are being reported. No US studies are yet completed.
North American studies of creams containing nitroglycerin that are applied to the penis have shown modest success in mild to moderate erectile dysfunction. Plans to study this drug in the US are planned. South American studies of creams containing prostaglandin (Alprox-TD) that are applied to the penis have shown modest success in mild to moderate erectile dysfunction. No plans to study this drug are planned in the US for now.
Impotence is a treatable problem, and is not the inevitable consequence of aging. Almost all patients with impotence can be treated. A thorough evaluation looking for the causes of impotence can be followed by the appropriate diagnostic testing, and then a multitude of treatment choices become available to assure that each patient has a successful outcome. In terms of determining which therapy is best for each individual, one must be informed of all the various possibilities, both about the cause of the impotence and the type of treatments that are available. None of the treatments will significantly affect the ability to have an orgasm. About 35-50% of men that start with self-injection therapy or vacuum devices will not be satisfied and will seek other treatments. Some men will, unfortunately, give up and not seek additional help from their urologist. Penile prostheses have an acceptance rate of 90% or more but requires a procedure. MUSE suppositories are too new to give long term follow-up.
If needed, psychologic support and counseling by a professional sexual counselor should be considered in many patients regardless of the cause of the impotence to help with any adjustments. Sex therapy is often helpful and can be done by a qualified psychiatrist, psychologist, physician, or sex therapist with training and experience in this specialty area. In addition to counseling, exercises and reading to help increase sexual skills and reduce anxiety and improve communications can be very helpful.
Reprinted with permission from Dialog Medical, dialogmedical.com.
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