The first commercial vacuum constriction treatment for erectile dysfunction was marketed in 1974 by Geddings D. Osbon Sr., a businessman from Augusta, Georgia. However, it was not until 1982 when FDA approval for these units as a medical device was granted. The VED may be manual or battery operated and includes the following components: the pump, cylinder, and constriction rings to decrease the venous outflow (i.e. help keep the blood within the penis for a rigid erection). VEDs work by generating negative pressure around the penis. The patient places the constriction rings on one end of the apparatus and then connects the pump to the cylinder. After lubricating the end at the base of the penis for a better seal, negative pressure is obtained by manual or automatic (battery) activation of the pump and simultaneous application of pressure on the cylinder toward the pubic area. It is generally not recommended to apply the device for more than 30 minutes at any one time.
VEDs may be effective for treating ED resulting from different causes, but those patients with severe ED and veno-occlusive dysfunction (i.e. “venous leak” or inability to store blood under high pressure in the penis) may not respond as well. Many physicians use VEDs in combination with other treatments for ED (i.e. injections or oral medications). Recent reports indicate that VED may also be effective in minimizing the slight penile length loss that can accompany penile implant surgery.
VED therapy is covered by Medicare and may be offered as first line of therapy by many physicians, although first line therapy has largely shifted to oral therapies since the latter were FDA approved. As compared to long-term injection therapies, urethral suppositories (i.e. MUSE), and penile prosthesis surgery, studies have shown that VED is the least costly alternative and may be a good option for older patients on a limited, fixed income.
The adverse events (i.e. complications) associated with the VED are typically mild when the patients follow the correct usage protocol. Patients who have bleeding disorders or unexplained priapism (painful erections that do not subside on their own) should not use the VED. Side effects such as occasional, transient numbness, pain, and penile bruising can occasionally occur, but are of minor clinical significance. Severe complications are extremely rare.
Reports on the satisfaction rates with VED are generally encouraging, although some studies have found that when followed for a prolonged period, a large number of patients (30-65%) stop using the device for a variety of reasons. The “drop-out” rates are lowest in patients who have mild to moderate ED. The convenience of oral therapies continues to challenge VED use. Not unexpectedly, studies have shown that when a patient responds equally well to the VED and the oral therapies such as sildenafil (i.e. “Viagra”), more than 2/3 choose the oral therapies. Nonetheless, there is a definite role for VED therapy alone or in combination with other modalities in the management of ED.