Injection and topical treatments for Erectile dysfunction

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Injection and topical therapies employ various agents that have properties that help achieve erection. The standard agents used include the following:

• Alprostadil.

• Phentolamine.

• Papaverine.

A 2000 study examined a progressive injection protocol that starts with a less complex and expensive combination of drugs and advances to more complex and costly regimens until positive results, if any, are achieved. The drugs used in the study’s protocol are papaverine, phentolamine, prostaglandin E1, and another agent, atropine sulfate. The logic behind the protocol is to find the least costly and complex therapy that works for the patient. Positive response rates were as high as 97.6%. Although any or all of these agents are very effective, injections or other invasive methods of administration are awkward and uncomfortable. Topical forms of some of these agents are showing promise.

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Treatments Using Alprostadil
Alprostadil is derived from a natural substance, prostaglandin E1, and acts by opening blood vessels. It is an effective alternative treatment for some men. It can be administered in three ways:

• By injection into the erectile tissue of the penis (Caverject, Edex).

• By a device that administers the drug through the urethra (MUSE system).

• In a topical cream (Topiglan, Alprox-TD).

Candidates. Regardless of how it is administered, alprostadil works in many men with a wide range of medical disorders related to erectile dysfunctions, including the following:

• Diabetes.

• Surgery.

• Injury.

Alprostadil is not an appropriate choice for the following individuals:

• Men with severe circulatory or nerve damage.

• Men with bleeding abnormalities or men who are taking medications that thin the blood, such as heparin or warfarin.

• Men with penile implants.

Side Effects of Most Alprostadil Methods. Certain side effects are common to all methods of administration, although they may differ in severity depending on how the drug is administered:

• Pain and burning at the application site. In one study half of the men with injected alprostadil experienced some burning and pain at the injection site.

• Scarring of the penis (Peyronie’s disease). Most likely with injections.

• Sudden, low blood pressure. Symptoms include dizziness, lightheadedness, and fainting. If these symptoms occur, the man should lie down immediately with his legs raised.

• Priapism (prolonged erection). Possible with any method, but less chance with the MUSE system than with injections. If priapism occurs, applying ice for ten-minute periods to the inner thigh may help reduce blood flow. Erections that last four hours or longer require emergency care.

• Effects on female partners. Women partners may experience vaginal burning or itching. The drug may have toxic effects if it reaches the fetus in pregnant women, so men should not use alprostadil for intercourse with pregnant women without the use of a condom or other barrier contraceptive device.

In addition, each method has other specific side effects. [ See discussions of individual methods below].

Injected Alprostadil. Injected alprostadil (Caverject, Edex) employs a very small needle that is injected into the erectile tissue of the penis. About 80% of men report the pain of administering the injection as being very mild. Edex is a newer and less expensive form of injected alprostadil. In one study of 894 patients, Edex injections achieved erections in 95% of attempts after 12 months. There is some evidence that the agent may have long-term benefits on smooth muscles and some men report some return to spontaneous erections after long-term use.

The drug should not be injected more than three times a week or more than once within a 24 hour period.

Specific reports of the severity of side effects using injections include the following:

• Pain and burning at the injection site. Half of men reported this side effect in one study. To help prevent this side effect, experts in one study recommended a lower starting dose of 2.5 micrograms with subsequent doses increasing by increments of 2.5 until an erection is achieved. In this study there were only two episodes of pain out of 138 injections. (Usually, patients start with a dose of 20 micrograms.)

• Priapism. Studies report that up to 4% of men using injection therapy experienced erections lasting more than four hours, but most cases resolve without treatment.

• Scarring (Peyronie’s disease). This occurs in almost 8% of cases of those taking injection therapy for more than a year. Treatment can be resumed when the condition resolves.

In spite of its general success, self-injection therapy has a high dropout rate and is less likely to be used now that oral treatments are available. The primary reasons for dropping out are the following:

• Loss of interest in the procedure.

• Partner objection or relationship breakup.

• Cost.

• Spontaneous improvement in erections.

• Side effects (reported as being severe enough to withdraw by 10% of men in one study).

• Lack of effectiveness (14% in one study).

MUSE System. The MUSE system delivers alprostadil through the urethra. It works in the following way:

• The device is a thin plastic tube with a button at the top.

• The man inserts the tube into his urethral opening right after urination. (Urinating or urine leakage right after administration may reduce the amount of medication.)

• He presses the button, which releases a pellet containing alprostadil.

• The man rolls his penis between his hands for 10 to 30 seconds to evenly distribute the drug. To avoid discomfort, the man should keep the penis as straight as possible during administration.

• The man should be upright, either sitting, standing or walking for about 10 minutes after administration. By that time, he should have achieved an erection that lasts between 30 to 60 minutes. (If a man lies on his back too soon after administration, blood flow to the penis may decrease and the erection may be lost.)

• The erection may continue after orgasm.

Studies on success rates have ranged widely, and in one study, only 18% of men requested additional refills. One expert believes that these less than optimal results may be due to the physician’s failure to discuss the procedure with the patients and their partners.

Specific reports of side effects using the MUSE system include the following:

• Burning in the Urethra. About 10% to 17% of MUSE administrations result in a burning sensation in the urethra that can last five to fifteen minutes. (This pain is generally mild to moderate, however, and is not a primary reason for discontinuing.)

• Penile Pain. Some pain in the penis occurs in about a quarter to a third of cases; it is usually mild.

• Low Blood Pressure. About 3% of patients experience low blood pressure.

• Drug Interactions. Taking certain cold and allergy remedies may offset the effects of the MUSE-administered drug.

• Other Side Effects. Other side effects include minor bleeding or spotting, redness in the penis, and aching in testicles, legs, and area around the anus.

The MUSE system should not be used more than twice a day and is not appropriate for men with abnormal penal anatomy.

Topical Cream. Alprostadil is being developed as a topical cream or gel (Topiglan, Alprox-TD). The cream is applied to the tip of penis 15 minutes before intercourse. Studies are reporting an efficacy rate of 40% to 75% and no significant side effects. The most common one reported is a burning sensation at the application site. The consequences to the female partner are not known.

Injections Using Papaverine and Phentolamine

Until the introduction of alprostadil, the two drugs used for injection therapy had been papaverine (Pavabid, Cerespan) and phentolamine (Regitine). Adverse reactions are usually minor but include pain, ulcers, and prolonged erections (priapism), which sometimes require a needle to withdraw blood or another drug to reverse the process. In a 2000 study, a combination of these two drugs produced a much higher drop out than alprostadil alone or a triple combination of all three.

Comparisons between Injection Therapy and Other Treatments

Comparison with MUSE System. In a 2000 study comparing alprostadil injection and the MUSE system, injection was preferred by more men and their partners. Edex was more successful in achieving erections sufficient for intercourse (82% versus 53%).

Comparison with Viagra. Penile injections have now largely been replaced by oral medications, specifically Viagra. Nevertheless, in one 2000 study comparing injections with Viagra, 43.6% of men who responded to the injections reported that they were more effective than Viagra and about half of these men opted for injections rather than medication. In another 2000 comparative study, about a third of the men selected penile injections over Viagra. 

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