Mechanical Devices to Treat Erectile Dysfunction

Erectile dysfunction is a very common problem but awareness has been slow because of the reluctance on part of the males to see/discuss with their physicians. Part of the problem has been embarrassment on the males. In recent years, physicians have made their patients more comfortable and this has helped in the evaluation of the major male sexual problem

Estimates indicate that more than 2.5 percent of men in the United States have erectile impotence. The causes of erectile impotence may be organic, psychological or both. Erectile dysfunction is caused by organic disorders in the majority of cases. Psychological factors are responsible for less than 10% of cases. Less than 5 percent of impotent men have no apparent cause for their erectile dysfunction.

What is available to treat erectile dysfunction

The majority of men with erectile dysfunction can be successfully treated with some type of therapy. When drug therapy fails, various mechanical devices are now available which are safe and effective for the management of erectile dysfunction. In addition implantable penile prosthesis have now become available which are the last resort of therapy for the condition. Penile implants remain the gold standard for the management of erectile impotence in patients with complete inability to have an erection. The manufacturers (who have a keen interest in the sale of these devices) claim a success rate of 80-90%. However, reports from patient surveys suggest that only about 60-70% of patients are satisfied. For excellent results it is recommended that adequate attention be paid to surgical detail and proper patient selection.

Mechanical Devices

When trials of drug therapy and withdrawal of offending medications prove to be ineffective in restoring erectile function, it is probably appropriate for most primary care physicians to refer to a specialist for additional evaluation and discussion of alternative treatment options such as intracavernous injection therapy, vacuum constriction devices, intraurethral therapy or possible surgery.

Mechanical devices for the management of erectile dysfunction include externally applied splints, constriction bands, vacuum constriction devices and penile implants. Over the years, many types of external splints/bands have been available, but none have been very successful. Vacuum constriction devices have gained acceptance only during the two decades.

Implants of prostheses into the penis did not start till 1973. The first implants were inflatable but semi rigid silicone rod prosthesis have become widely available and provide satisfactory results. Both types of implants have been improved, and several highly reliable prostheses are now available. Many individuals with poor heart function and prior history of stroke frequently use vacuum devices as a first line therapy

EXTERNAL DEVICES

A number of external vacuum constriction devices are available in the treatment of erectile dysfunction. The safety of these devices has been evaluated by the FDA and these devices are readily available with a physician’s prescription.

Vacuum Constriction Devices

The idea of using vacuum constricting devices to assist in the treatment of erectile failure is about 75 years old, but the concept was put into reality about 2 decades ago. These devices were first invented in the 1970s and delivered to men via the US postal service. However, this business was initially considered pornographic and obscene. The business was almost ended before it could be started. Finally, better marketing and education of physicians and law officials led to the establishment of this credible medical device company.

The system consists of an acrylic cylinder in which the penis is placed. A lubricant is used to achieve a good seal between the penis and the cylinder. Vacuum is applied to the cylinder and an erection is achieved. This negative pressure pulls blood into the penis and produces an erection-like state.          

Once an erection is achieved a constriction band is applied to the base of the penis to maintain the erection. The constriction band helps maintain the engorgement of blood in the penis and keep it rigid. The penis is then withdrawn from the cylinder and the patient is ready to have intercourse. It is recommended that the band be applied to the base of the penis for no more than 30-45 minutes. If repeat sexual activity is required, the procedure can be repeated.

Availability and Cost

When the devices were first available, a prescription was required for purchase. However, many companies do sell these devices without a prescription. But if reimbursement is required from Medicare or your insurance company, then a doctor's prescription is a must.

Like everything in life, cheaper versions of these devices cost less. The basic models start at around $ 100 and the ultra deluxe light weight devices can cost anywhere from $3-500. The market for these devices is so great that even our beloved Walmart sells these devices and their shelves rapidly empty, especially during special occasions.

Results

Survey of numerous males suggests that these devices are effective and acceptable in the treatment erectile dysfunction of varying etiology. While the initial overall response rate is approximately 80% to 90%, longer term follow up studies reveal that about 50-60% of individuals use the device regularly.

After the initial excitement of achieving an erection, most men claim the vacuum devices are okay. The majority of men can achieve an erection which can last anywhere from 5-20 minutes. The major complaint was that the penile rigidity is not firm enough and that repeat use of the device was required for prolonged sexual activity. Another complaint is that the erection only occurs distal to the constricting band and the base of the penis remained flaccid and many a times prevents insertion for intercourse. However, most men said that being able to achieve an erection was important for self image and improved their relationship. Persistent users have progressively less difficulty manipulating the devices, and the time required for them to achieve an erection or erection-like state lessens.

A positive aspect of the devices, unlike drugs, is that they are usable and repeat use does not cost any money. The devices can be cleansed and re used.

Complications

There are a few complications associated with the use of vacuum devices. A few patients have also complained that if the constriction band on the base of the penis is too tight, sperm cannot be ejaculated and occasionally develop a pain distension. Other may develop some bruising at the base of the penis, numbness or coolness of the penis and pivoting of the penis at the base.  For the perfectionist these complications may be troublesome but for the majority who just want an erection, they are bearable. For those who are not satisfied with these devices, the next step is surgery or a visit to the psychiatrist.

One has to remember that despite these minor problems, these devices have become an integral non-surgical option for some patients with erectile dysfunction.

Contraindications

There are relatively few contraindications to the use of this device and individuals with sickle cell anemia, bleeding disorders and those taking blood thinning medications should not use these devices

Implanted INTERNAL DEVICES

A few individuals with erectile dysfunction may require the ultimate therapy. Implantation of a penile prosthesis is a common procedure and in the past decade has become the treatment of choice for many individuals. However, once a penile prosthesis is implanted, a significant amount of irreversible damage occurs to the penile tissues. The muscles can be severely damaged and thus lose their elasticity and erection can rarely be achieved spontaneously. For this reason, implantation of penile devices is a last resort treatment

Questions about Penile Prosthesis

Individual who are about to get a penile prosthesis are very anxious. The anxiety and apprehension is common and some of the questions asked are:

-          where is the prosthesis going to be placed

-          how it will be placed

-          how it will function

-          with a small deflated penis, how will all that equipment fit into me

-          Will sex feel natural?

-          Will I be able to ejaculate?

-          Will other people know that I have an implant?

-          Will I look natural?”

-          Is the implant permanent

-          It the surgery painful

Getting a penile implant requires a combined decision from the couple involved. The couples should be educated on all aspects of the implant and the decision to get an implant should be based after being informed on other alternatives. There are two versions of the devices- semi rigid or inflatable implants.

How Does a Penile Implant Work?

A penile implant provides firmness/rigidity to the penis. The implant is a cylindrical rod which is placed in the penile muscle tissues to give rigidity so that sexual intercourse can take place. Over the last decade, Over 250,000 implants have been inserted. If the individual was able to achieve orgasm and ejaculation prior to the implant, than these functions will be maintained with the implant.

For those men who had lost the ability of orgasm and ejaculation following prostate surgery or radiation, the implant will only provide an erection and a mild sensation of orgasm. The implant is not designed to restore ejaculation or orgasm. Today, several varieties of penile implants are available.

Semi-Rigid Implants

These were the first implants developed. They are made of silicone and are devised in such a way that during an erection the device is pushed out on to the penis and later partially retracts. These semi rigid implants are usually inserted in individuals who are not fully able to use their hands (due to arthritis). The devices are simple to use and have few complications. The devices are easily inserted. However, they may become obvious as they do not completely retract.

Inflatable Penile Prosthesis

The inflatable penile devices were first developed 30 years ago and have had good success. Over the years, newer generation of these devices have been developed. Initially the inflatable penile prosthesis had numerous technical problems but today the majority last at least 5 years. Technological advances have helped in making stronger material and smaller appliances and most manufacturers give the patients a life time guarantee on their products with free re-placement of the implant in case of mechanical malfunction.

The inflatable penile prosthesis consists of two small cylinders which are implanted into the penis. A micro pump is implanted in the scrotum, and a reservoir is placed in the same area. The reservoir contains the fluid which will inflate the prosthesis. The entire device is not visible to the naked eye. The device is activated when one pushes the pump trigger through the scrotal skin. The pumping action transfers fluid from the reservoir into the penile implants which cause the erection.

The inflatable penile prosthesis are simple to implant. Once implanted, they are not visible to the naked eye. However, manipulation of the groin will reveal the presence of some hardware. Because these devices are mechanical, technical problems are more frequent than the semi rigid prosthesis

Procedure

These devices are typical placed in those who have failed to respond to drug therapy. These prostheses can be inserted at an outpatient surgery center or as an inpatient in the hospital. The procedure takes about 1-2 hours and there is minimal pain associated with the procedure. Once the incisions have healed, the device is ready for use.

Individuals with penile implants can resume most activities. A man can even shower at the local club and the implant would not be obvious. The procedure is tolerated and associated with minimal pain. There is localized tenderness and bruising near the scrotum which lasts for a few weeks. Most men can return to work after 2-4 weeks.

Results

Depending on whom one talks to, the satisfaction rate is variable. As always the doctors and the manufacturer over estimate the satisfaction- claiming that 90% of men are in a state of Nirvana. However, surveys of men who have undergone the procedure reveal that about 50-70% are satisfied.

Penile implants are a last resort to a difficult problem and the individual has to be realistic in his expectations. The device does help produce an erection, but neither ejaculation nor orgasm is promised. For those men who are realistic, a well placed device can help one enjoy an active sex life until the device fails.

Complications

Complications are more common with inflatable devices and include pain, erosion, extrusion, infection, breakage, malposition and malfunction. Inflatable devices most commonly malfunction due to leakage of the fluid from the reservoir or the prosthesis- akin to water leaking out of a portable swimming pool. Rarely, the presence of pain or an infection requires removal of all the hardware.

Device failures and Cost

As with any mechanical appliance, the number of implant failures increases with time. The majority of these devices work for 5-7 years and with better technology, the technical failures have markedly decreased.

The penile implants may be rather expensive and prohibitive for a number of men. The cost can range anywhere from $3-10,000. The procedure may not be covered by the insurance companies and Medicare may pay some of the costs. With no real guarantee of a result, some men would prefer to spend the money fixing the kitchen sink.

Conclusion

Today there are millions of men use these mechanical devices to mange their erectile dysfunction. These devices, though not ideal, allow the impotent men to regain his ability to achieve sexual intercourse and a satisfactory sexual life style. A few advantages of these devices include no medications and their rising costs and no repeat injections. . Some men even claim that the use of these devices has enlarged their penis- dream on.

However, the downside is that the sex is not spontaneous and requires some mechanical preparation. The partner has to be understanding and patient.

It must be emphasized that these mechanical devices are an alternative treatment for patients who have no other option. Vacuum constriction devices are often considered second and are generally recommended when oral therapy fails. This is followed by the implantable devices. Even though there are no Federal policies on which is the preferred therapy for erectile dysfunction, always seek a second opinion if surgery is recommended prior to drug therapy for erectile dysfunction.