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Pharmacologic Erection Program

Pharmacologic Erection Program

A penile erection results when stimulation of the nerve of the penis releases certain substances call neurotransmitters. In the erection tissue these substances initiate both an increase in arterial blood inflow and a decrease in blood drainage. The net effect of these hemodynamic changes is an accumulation of blood and thus and increase in pressure within the erectile tissue. When the pressure is sufficiently increased the penis is sufficiently rigid for successful intercourse.

Researchers have demonstrated that a penile erection rigid enough for sexual intercourse may result following the injection of small amount of a drug combination into the erectile tissue of the penis. This treatment for male impotence called Pharmacologic Erection, has already enabled numerous patients to resume sexual intercourse without the need of surgery a penile prosthetic device or Erection Aid Devices. From time to time patients do not respond to the single use of Caverject« and a combination of drugs must be used in order to achieve a full erection. Although our policy is to use Caverject as a first line of therapy we provide the following information for educational purposes. Please remember the following mixtures are not approved by the FDA.

The drug combination consists of Papaverine Hydrochloride and Phentolamine Mesylate. In erectile tissue both drugs mimic the action of natural neurotransmitter substances and cause both an increase in arterial blood inflow and a decrease in blood drainage. Thus injection of these agents into erectile tissue allows for a rigid penile erection to occur.

The rigidity and duration of the erection may be dependent on the dose of the drug injected. The usual initial dose of 1 cc. of the drug combination consists of papaverine 25 mg., and phentolamine .83 mg. Some patients respond well to papaverine alone without phentolamine. It has been our experience that the pharmacologic erection so achieved, may be improved in duration and rigidity with sexual stimulation. The drugs do not usually interfere with either ejaculation or orgasm. At present is a rational option for patients with neurologic impotence, whose penile tissue and blood supply are normal, but whose nerve to the penis is abnormal and some patients with mild vascular impotence. This program may be used to delay or defer indefinitely the more traditional treatment option by penile prosthesis implantation. The long term effects of repeated injections into the erectile tissue is unknown. It is felt that repeated penile injections should not, however, interfere with implanting a prosthetic device at anytime in the future.

Anatomy: The penis consists of two erectile cylindrical bodies called the corpora cavernosa and a urination component called the urethra. The urethra starts at the base of the bladder and ends at the meatus in the head of the penis. This tube conducts urine from the bladder out the end of the penis. It is soft cylindrical and is easily felt along the shaft of the penis on the bottom. Also along the top of the shaft of the penis are important nerves, arteries and veins. These structures provide for sensation of the penis, arterial blood supply to the shaft and head of the penis as well as venous drainage from these areas.

The two erectile bodies begin in the crotch area near the buttocks and end underneath the head of the penis. It is important to realize that these two erectile bodies constitute the greater portion of the shaft of the shaft of the penis. Thus, it is relatively easy to locate and self inject this area. With the penis held taut to the left or right over the upper portion of the thigh, the area for injection lies in the base of the penile shaft. The erectile body can be felt with your fingertips as a smooth, slightly firm area just below the area of the nerves, arteries and vein and just above the urinary channel (urethra).

Equipment Needed for Self-Injection:

  1. Alcohol sponges.
  2. One cc. insulin syringes with 27 or 28 gauge needle.
  3. Pre-mixed PAP-REG (R) mixture or triple mixture sold by Urology Consultants in any of our locations after proper medical evaluation. Medicine should be kept in the supplied cardboard box; exposure to light results in discoloration. This medicine will last longer if refrigerated (Do not freeze).

Procedure: The self-injection technique for pharmacologic erection is performed in three separate stages.

  1. Syringe Preparation: The first stage consists of preparing the syringe for injection. First, wipe the rubber top of the premixed medication vial with an alcohol swab. Take a new, sterile one ml. syringe and remove the plastic cap overlying the needle. Place the plastic cap overlying the needle on a flat surface with the open end up. Do not contaminate the open end of this plastic cap. Withdraw the barrel of the syringe back to one ml. pierce the needle of the syringe into the center of the rubber diaphragm of the vial. Do not contaminate the needle by touching the surrounding metal cover of the premixed vial. Inject the one ml of air into the vial so that no vacuum is created in the drug vial and slowly withdraw one ml. of the drug solution. The vial and syringe should be in a vertical orientation to minimize withdrawal of air. If there are air bubbles in the syringe, tap the syringe gently or inject the solution back into the vial and slowly withdraw again. Carefully replace the plastic cap over the needle. Do not touch the needle to the sides of the plastic cap. Should contamination of the needle occur at any time either by touching the metal ring of the medicine vial, touching an edge of the plastic cap or touching your fingers, both syringe and needle should be discarded.

     

  2. Skin Site Preparation The second stage consists of preparing the skin at the base of the penis for injection. First, grasp the penis just underneath by the glans (head) using your thumb and first three fingers. If you are right handed, this is usually accomplished with the left hand. If you are left-handed, this is usually accomplished with the right hand. Your thumb and first three fingers should form a vise-like, non slip grip of this area. Stretch the shaft of the penis taut to your left or right over the upper thigh area. Feel with your fingers along the side of the base of the shaft. The important arteries, nerves and veins of the penis lie on top. The softer urinary passageway lies on the bottom, the firmer and wider erectile body lies in front. Next, thoroughly clean the area at the base of the penis overlying the erectile body with a fresh alcohol swab.

     

  3. Injection/Compression: The third stage consists of injecting the drug solution into the erectile bodies followed by a three to five minute period of compression of the base of the penis. First remove the plastic cap overlying the needle. Grasp firmly under the head of the penis and position your penis as previously described. Hold the syringe with your injecting hand like a cigarette between the first and second fingers with the thumb pressed against the end of the syringe. Your thumb will provide the necessary forward strength for the injection. Locate the site of injection overlying the erectile body. Place the needle on the skin site without piercing the skin. Check that the needle is correctly positioned 90 degrees to the erectile body. Check that the needle will avoid small skin blood vessels. When sure of the needle location "dart" the needle into the erectile body all the way to the hub of the needle. You should be able to feel the resistance of the needle piercing through the firm lining of the erectile body. Carefully move your thumb from the end of the syringe to the end of the plunger. Slowly inject the drug solution into the erectile body. Do not allow the penis to rotate or move. Injection should meet little resistance and should not be painful. Inject the entire amount slowly, then withdraw the needle and discard. Compress the injection site for three to five minutes using the alcohol swab. Your thumb can be placed on the injection site while your first finger is placed at the opposite side of the penis shaft. If pain occurs during injection withdraw the needle immediately and compress the injection site for three to five minutes.

A proper placed injection is usually painless, when pain occurs is due to a shallow placed needle and injection of the solution into the subcutaneous tissues.

Complications: There have been few complications from repeat injections of the drug combination. The following however, must be considered and possibly happening. The needle may

  • Cause bleeding in a skin blood vessel.
  • Be inserted to shallowly and not penetrate the erectile tissue.
  • Be inserted too high and injure nerves/arteries or veins of the penis.
  • Be inserted too low and injure the urinary passageway of the penis.
  • Ccause irritation of the skin to the penis.
  • Cause infection of the skin or of the erectile tissues.
  • Cause scarring of the erectile tissue or injury to the artery of the erection tissue.
  • Cause infection which spreads to another location of the body (heart valves, bone, etc). The drug and combinations or drugs are not approved by the FDA for this use. Urologists throughout this country have used this type of injection extensively during the last 20 years.

Due to insurance carrier regulations you will be requested to sign a disclaimer and consent form accepting the risks of this injection program and understanding that the product although widely used, is not approved by the FDA or endorsed by any of the manufacturers of the drug for this particular purpose.

The papaverine-phentolamine drug combination has a low toxicity. Each drug has been used safely for many years in this country in much larger doses for disorders involving vasodilatation (such as impending stroke or hypertensive crisis). Rare drug side effects which have been reported in other usages include heart rhythm changes and liver injury. These have not yet seen with the small doses used in this procedure.

More commonly, the drug injection may result in prolonged erection greater than 8 to 10 hours in some patients. Thus far this has only occurred during initial test dosing. It is felt to occur only in patients very sensitive to the drug combination. In the few patients that this complication has occurred, successful treatment by irrigation of the erectile body with an antidote to the drug solution has been carried out, usually in our office as an outpatient.

Usually after a few visits to our office the patient is able to inject himself and return initially on a monthly or bimonthly basis for follow up.