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Penile prostheses for the treatment of ED have been available for more than 30 years in the US.

A key discovery in the field of penile prosthetics was that the corpora cavernosa could be accessed surgically without damaging the penile vessels, urethra or sensory nerves. The most commonly used implants are multi-component inflatable implants, consisting of two or three components. Inflatable cylinders placed in the corpora cavernosa, a fluid reservoir implanted in the abdomen or lower pelvis and a small pump placed in the scrotum.

The user squeezes the pump and fluid moves from the reservoir into the cylinders to create an erection.

A further squeeze of the pump reverses the process.

The main problem with penile implants is that the normal functionality is damaged permanently, meanwhile a devise like PotencyFlow® adds to your exiting functionality. 3 Belsley et al., 1998; Brooks & Jordan, 2001 4 Garber, 2005. Implantica is developing products for the treatment of Erectile Dysfunction (ED).

The company is focused on high technology products which are designed to help patients attain a higher quality of life and provide benefits over current existing products by being easier to use and generally more acceptable to the patient population. Formerly known as ‘impotence’, the term Erectile Dysfunction (ED) is now more often used to distinguish it from other problems related with sexual intercourse, e.g. lack of sexual desire or ejaculation and orgasm problems (Brooks & Jordan, 2001). ED is treatable and not a life-threatening disease. However, the condition may result in numerous social and personal problems: depression, withdrawal from sexual intimacy, marital problems, reduced quality of life, decreased working productivity, and increased healthcare utilization (Dhanani et al., 1998, cited by Joyce et al., 2007).

With the introduction of Viagra in 1994, the market for erectile dysfunction treatments boomed.

Still, many men hesitate to seek help due to the social stigma and

embarrassment

Satisfaction is determined by both patient and partner, making ED a ‘couple’s disease’. The degree of ED can range from a total inability to achieve an erection, an inconsistent ability to do so, or a tendency to sustain only brief erections.

The World Health Organisation specifies a three-month minimum duration of symptoms to establish the diagnosis (WHO cited by

Joyce

The corpora cavernosa are surrounded by a membrane called the tunica albuginea. The spongy tissue contains smooth muscles, fibrous tissues, spaces, veins and arteries. The urethra runs along the underside of the corpora cavernosa in the corpus spongiosum and is the channel for urine and ejaculate.

An erection is a complex, involuntary, neuropsychological, hormone-mediated, vascular event, which begins with both sensory and mental stimulation. Impulses from the brain and local nerves cause the muscles of the corpora cavernosa to relax, which allows rapid blood flow to fill the spongy chambers, thus creating pressure in the corpora cavernosa and expanding the penis. An erection is sustained when the tunica albuginea helps trap the blood within corpora cavernosa, but is reversed when the muscles in the penis contract, which stops the inflow of blood and opens the outflow channels. As previously

mentioned

ED can occur when any of these events are disrupted. Brooks & Jordan (2001) states the

cause

The condition can be categorized as

psychological

Psychological factors include stress, anxiety, and guilt, lack of self-esteem, depression, and fear of sexual failure.

Physical factors are more prominent, and can be things such as: System diseases, for example: cardiac, hepatic, renal, pulmonary, cancer, metabolic, post organ transplant, pelvic irradiation.

Androgen deficiency, as androgen resistance, other endocrinopathies. Vascular insufficiency, like atherosclerosis, pelvic steal, penile Raynaud’s syndromE, venous leakage. Neurological disorder: Parkinson’s, Alzheimer’s, Shy-Drager, encephalopathy, spinal cord or nerve injury. Penile disease: Peyronie’s disease, priapism, phimosis, smooth muscle dysfunction, trauma.

Many of the above causes of this disease relate to high age.

(2007) states that 69.4 % of all 70-76 year old men suffer from erectile dysfunction to some extent. In this study, at the age of 50-54, 26.0 % of all men have ED, which supports the over the counter sildenafil cvs above statement.

In the US, erectile dysfunction is more common among obese men and men with diabetes (Carson et al., 2007). ED is and will continue to be a significant problem.

Today patients developing ED generally have a higher expectation in terms of quality of life and the effects of ED will most certainly be even harder to cope with for these patients. Due to the many different causes of ED there are numerous treatment methods, spanning from oral drug treatment to surgical methods such as penile implant. However, most physicians agree that the treatment path adopted should begin with the least invasive and

end

Usually, oral drugs are the first step in ED treatment and are referred to as first line treatment. There are a number of pharmaceuticals used to treat erectile dysfunction, the most common being so called PDE5 inhibitors.

Oral drug treatment is relatively easy to explain and maintain and patients are easy to motivate.

Many different agents exist, but in recent years, two groups of agents have become the most commonly used: Phosphodiesterase (PDE5) inhibitators. The erection process involves the release of nitric oxide (NO) in the corpus cavernosum. This step increases the levels of cyclic guanosine monophosphate (cGMP), which leads to smooth muscle relaxation (vasodilation) in the corpus cavernosum, which in turn increases in the inflow of blood. The most known phosphodiesterase-5 (PDE5) inhibitor Sildenafil Citrate (Viagra™) was introduced in the US in 1998.

It is one of three oral PDE5 treatments used today (the other two being Cialis™ and Levitra™).

the patient’s normal sex drive is not affected directly but the ability to get a full erection is enhanced. They are

not

Common side effects include headache, dizziness, facial flushing, sneezing and visual changes (due to its effect on PDE6, which is present in the retina of the eye) (Pfizer, 2007).

About 30 % of men fail to respond to PDE5 inhibitors and another 20 % suffer significant side effects (McCullough, 2007). Apomorphine over the counter

sildenafil

The reason is that PDE5 inhibitors such as Viagra are efficient and currently dominate the market (Frost & Sullivan, 2005). Penile injection has been used as a second line treatment for over a decade.

It has a 70-90% success rate, higher than PDE5 inhibitors, but it is not generally considered a popular form of treatment with patients because of the need to administer regular self-injection into the corpora cavernosa of the penis (Belsley et al., 1998; Brooks & Jordan, 2001).

The most common drug is prostaglandin E1 under the name Alprostadil. This drug is a vasodilator, which causes blood vessels to expand and thus blood flow to the penis increases.

The use of injections can lead to scarred tissue and risk of wrong dosage that in severe cases damaged tissue in the corpora cavernosa.

Alprostadil usually begins to work in about 5 to 20 minutes.

Intercourse should be attempted within 10 to 30 minutes after using the medication. This will produce an erection that lasts about an hour. It is advised to use no more than three times per week with at least 24 hours between each use.

There is a reported 37-70 % dropout rate, mostly due to fear of injections or lack of spontaneity (Kandeel et al., 2001; British Society for Sexual Medicine, 2007).

With a better method of treatment the high dropout rates will certainly fall. Furthermore, an easier method of drug delivery may reach a broader patient group, patients that cannot take injections due to various problems.

This is another second line treatment, but without the injections. Following urination, a small pellet is inserted approximately an inch deep into the urethra via an applicator at the tip of the penis. It is most commonly known under the name of MUSE, “medicated urethral system for erection”. Since the introduction of above mentioned oral PDE5 inhibitors, urethral suppositories have diminished. The method is just slightly easier to self-administer than injections and it also suffers from the lack of spontaneity. Due to the scaring of injections of Alprostadil and the cardiac side effects of existing oral treatments such as Viagra, intranasal therapy and topical therapy are interesting alternatives for future patients. Intranasal therapy method uses a faster way of delivering an active substance for ED patients through the nose.

Using this method gives rapid drug absorption via highly vascularised mucosa and a rapid onset of action (Frost & Sullivan, 2005). Topical therapy is a method already existing under the name of Befar (with Alprostadil) produced by NexMed. It is a cream that delivers the active substance through the skin.

It is applied to the opening of urethra and is therefore a less invasive way than injections.

Mechanical vacuum devices cause an erection by creating a partial vacuum around the penis, which allows the inflow of blood and the penis to engorge and expand in a way similar to a natural erection. The device is made of three necessary components: a plastic cylinder that covers the penis, a hand or battery pump, which draws air out of the cylinder, and an elastic ring, which is fitted over the base of the penis and maintains the erection.

A typical erection lasts up to 30 minutes using a vacuum pump and should not be longer because of the development of ischemia (absolute or relative shortage of the blood supply to an organ) Third line treatments. Patients generally have tried both drugs and other treatments before they are considered suitable for third line treatment. Of all ED patients, 6-10 % reaches these invasive treatment methods (HBS Consulting, 2007).

Approximately 25 000 patients every year are treated with penile implants/prosthesis (AMS, 2006).

In some cases, surgery is used to repair damaged arteries and tie off veins. The most common methods are

called

surgery