Vacuum Device

Vacuum erection devices, also known as vacuum constriction devices have been utilized for improving erectile rigidity for over a century. In its current form it has gained popularity only over the past twenty years. It has been FDA approved for use in the management of men with erectile dysfunction (ED). There are a number of medical equipment companies that have specially-designed devices which are carefully constructed so that a limited amount of pressure is allowed to develop. This is to reduce the likelihood of pressure-induced penile injury. This pressure is approximately 200-250 mmHg. In contrast, there are devices available, generally termed “penis developers” which have not been tested and can expose the penis to pressures well in excess of the above figure. Often these devices can be obtained through mail order companies. It is important for clinicians and patients to be aware that these instruments are potentially dangerous and have no FDA clearance. Patients with ED and without ED are to be discouraged from using these latter devices.

The Device

The vacuum device consists of a clear plastic cylinder with an aperture at one end that is placed over the penile shaft. At the other end of the cylinder is a pump mechanism that is used to generate negative pressure within the cylinder. The pump mechanism can be in the form of either a manually operated or a battery-operated system. The former generally requires two hands to control the device, one on the pump handle and the other to steady the cylinder on the penis itself. The battery-operated device can be used with one hand. In this system, the trigger mechanism is on the top end of the cylinder and thus one hand can activate the pump and steady the cylinder at the same time. This is an important consideration for patients with poor manual dexterity or strength, such as men with Parkinson’s disease or rheumatoid arthritis. All FDA approved cylinders have pop-off valves, which limit the amount of pressure held within the chamber.

Technique

Once a decision has been made to pursue sexual relations, water-soluble jelly is applied to the base of the penis. This maneuver prevents air from seeping into the chamber, by creating a water-tight seal, thus maintaining the negative pressure within the cylinder. Some men may find that trimming the pubic hair may aid achieving this water-tight seal. Once the cylinder has been placed over the penile shaft and held firmly against the pubic bone, the pump mechanism can be activated (either by hand or battery). Slow generation of the negative pressure prevents penile pain due to too rapid a build-up of pressure within the cylinder. The negative pressure causes an inflow of blood into the corporal bodies, both arterial and venous in nature. The latter blood is drawn into the erectile chambers in a retrograde fashion.

Many men find that “double-pumping” increases the comfort level. This technique involves the generation of negative pressure and then letting some of the negative pressure off, waiting a while and then recommencing with the negative pressure build-up and repeating the process until a full erection is achieved. Early on in a patient’s experience with the vacuum device, this technique is to be encouraged until the patient develops a comfort level with the amount of negative pressure that he can tolerate and that gives him a functional erection. Once the erection has been achieved, a constriction ring (band) must be applied to the base of the penis to act as an artificial valve, thus maintaining the blood within the corporal bodies. The rings come in a variety of shapes, sizes, and most importantly tension (tightness). Trial and error is used to define which ring size is most comfortable and efficient. Most manufacturers suggest that the constriction ring remain in place for no longer than 30 minutes. Once the ring is in place the plastic cylinder can be removed and sexual relations may commence.

Indications

The vacuum device is indicated for men with ED. There are no specific conditions that would interfere with the use of these devices. However, caution should be exercised by men if they are (i) using blood-thinners or have a history of bleeding disorders (ii) have diminished penile sensation (iii) have significant penile curvature or (iv) have a history of priapism (prolonged erection) or are at risk for its development (see section on Priapism). Anticoagulant therapy may cause the patient to develop bruising and swelling in the penis due to rupture of the superficial veins on the shaft of the penis resulting from the constriction ring. In the patient who is not on anticoagulant therapy this trauma is uncommon and if it occurs usually resolves of its own accord. Given this, we avoid the use of a vacuum device in this patient population. Likewise, patients with a history of bleeding disorders should be directed toward other treatments.

Patients who have reduced sensation in their penis, especially men with spinal cord injury, are at risk for trauma with repeated use of the constriction band. It should be used with extreme caution in this group and the ring should be applied for only short periods of time. Men with Peyronie’s disease (acquired penile curvature) or congenital penile curvature, with significant degrees of curvature should be discouraged from using a vacuum device as the straight cylinder may exert significant stress on the curved penis resulting in trauma to the already bent shaft of the penis. Patients with hematologic forms of venocclusive priapism (sickle cell disease, thalassemia, or leukemia) should not use a vacuum device under any circumstances.

The above patient groups represent just a tiny fraction of all patients who present for the evaluation and treatment of ED. The VED is a simple and safe form of impotence therapy. It typically receives good insurance coverage and, most importantly, it is totally reversible. If the patient does not wish to continue with this therapy, it is easily stopped and if used in a proper fashion no long-term negative effects will have occurred. It has minimal disadvantages. It is easy to use, although we suggest to all of our patients to spend one visit in clinic to be formally and properly educated regarding its optimum use. We have found that patients’ acceptance and compliance increase with this approach. However, there are a significant number of patients who find this treatment option unacceptable. Many feel this way because of two important factors, namely cosmetics and difficulty integrating this technique into love-making. In the white male the inflow of blood combined with the application of a constriction band renders the penis cool in temperature and causes a large amount of superficial vein swelling. These factors make the vacuum device erection a non-cosmetic one and the younger patient and the impotent patient who is currently not in a stable long-term relationship often find this unacceptable. It has been estimated that the surface temperature of the penis during use of the VED is 1°C lower than the temperature prior to application of the device. The patient and his partner should be counseled regarding this fact prior to the initial use of the device. The average man using such a device will typically take 10-20 minutes to obtain a significant erection of penetration rigidity. This time combined with the mechanical nature of the treatment modality makes this option cumbersome for some men and they may have some difficulty integrating it into sexual relations.

Side Effects

Bruising, skin breakdown, and penile pain associated with the application of the constriction band have already been discussed. The tightness of the band may also result in failure to achieve an ejaculation (although no interference with orgasm should occur) and the development of a temporary penile numbness. One of the other problems with the erection achieved with the vacuum device is that it may hinge at the point of application of the constriction ring. That is, the penis behind the ring is soft and only that portion of the shaft that is beyond the ring has any degree of hardness. Therefore, the ring must be applied as far towards the base of the penis as possible.

Results

Despite the apparent drawbacks to the use of vacuum devices, there is a population of patients who find its use easy and it has allowed many couples to successfully resume penetrative sexual relations. A number of reports have cited satisfaction rates above 80%. This treatment has been shown to result in definite improvement in erection hardness, increase in frequency of sex and increase in overall sexual satisfaction. Increased satisfaction for the partner has also been demonstrated. Drop-out rates of up to 30% have been cited and the commonest reasons for drop-out include, inadequate rigidity, penile pain, failure to ejaculate and dissatisfaction with penile appearance and temperature. The vacuum device is suitable for all groups of patients with ED except those listed as contraindications above. Patients should be comprehensively counseled regarding the pros and cons of this modality. Furthermore, patients should not be just sent home with a video to watch, they should have in-office counseling by a health care worker experienced in the working of the device. This approach maximizes patient acceptance, satisfaction, and long-term compliance. In the era of oral therapy, the vacuum device is currently viewed as a second-line therapy, one which, however, has good patient/partner satisfaction and an excellent safety profile.