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Vacuum constriction devices for treating ED

Patricia Allen
MA DipN(Lond) RM RGN
Clinical Nurse Specialist
Royal Hallamshire Hospital
Sheffield

Impotence, or erectile dysfunction (ED), affects as many as two million men in the United Kingdom. Prolific media attention, especially since the introduction of Viagra, and the breakdown of sexual taboos have led to increased awareness of sexuality and higher sexual expectation.

A decrease in the stigma of ED, allied to an ageing world population with a prevalence of chronic disorders, such as diabetes and vascular disease, has meant an increasing workload for healthcare professionals in this field. Consequently, the treatment of sexual dysfunction has attained a higher priority than ever before.(1)

Reflecting the upsurge in interest are the huge strides taken in the treatment of erectile dysfunction, with options ranging from oral medication (eg, Viagra, Cialis, Levitra),(2) intracavernosal injections of vasoactive compounds (eg, Caverject, Viridal duo),(3) androgen therapy(4) and surgery (eg, penile implants).(5)

The need for a safe, reliable, reversible and non­invasive technique led to the development of the vacuum/constriction device (VCD),(6) and more recently the construction band alone, as a treatment for the patient with ED.

Following their introduction in 1982, VCDs were initially seen in some quarters as no more than "gadgets that artificially increase the blood supply to the penis".(7) However, there has subsequently been widespread acceptance and awareness of their use by the medical profession. So much so that, by 1991, it was suggested that vacuum devices were prescribed more often than any other successful treatment,(8) becoming an integral part of the armamentarium to treat ED.
 
Since then, however, with the advent of the intra­urethral therapy MUSE (Medicated Urethral System for Erection) and the oral preparations such as Viagra, the use of VCDs as a first-line treatment has declined.
 
However, the VCD has still an important role to play in the treatment of ED, as increasing numbers of patients with ED are finding that oral and other medications either do not work or cease to work after a period of time.

Vacuum constriction devices and how they work
The device consists of a cylinder, pump (battery-operated or manual) and constriction rings. A vacuum is created over the flaccid penis and, by creating negative pressure within the cylinder, blood is drawn into the penile tissues, which creates an erection. This can then be maintained by applying a constriction ring around the base to prevent blood flowing back into the circulation.

Efficacy
Since their introduction, many studies have been carried out to assess efficacy of the VCD. The data in the literature tend to uniformly predict successful erections being attainable in 84-95%(9-13) of cases with overall satisfaction, with the device having slightly less impressive rate due to side-effects, with figures ranging from 72-94%.(10-12,14)

A postal study of 160 couples from our centre in Sheffield confirms that 85% had an erection with quality sufficient for intercourse, and 69% were satisfied and continuing to use the VCD at one year, and 50% at three years (personal data).(15)

Role of vacuum devices in the treatment of ED
In the early days of physical and pharmacological treatment for ED, the only treatments available were penile injections, VCDs and penile implants. Since then, advancements in knowledge have led to the introduction of other treatments, including MUSE in 1996 and the revolutionary oral medication Viagra in 1998. Other oral medications have followed, including Cialis, Levitra and Uprima. However, in spite of this, the VCD still has a major role in the treatment of ED. Many patients now currently qualify for treatment with drug therapy on the NHS, but for a percentage these drugs are not appropriate or may be contraindicated due to the possibility of drug interactions.

Many men do not like taking medication, and very often, due to underlying medical conditions, such as vascular disease and diabetes, medication does not work very well, even if they are happy with taking it. The VCDs could be ideal for these patients, and now the availability of them in the NHS is to be welcomed for certain categories of patients.

The VCD is a noninvasive, safe and efficient treatment, and now that the majority of men have to pay privately for treatment, it is also cost-effective compared with the cost of drugs. Most VCDs available for purchase have a lifetime guarantee, so it is a "one-off" payment and in the long term works out much cheaper financially (prices range from £90-£200 or more) than continuously purchasing prescription medications, and this is a popular reason for choosing the VCD.
 
Acceptability of device use

Advantages
Couples who benefit the most from the use of a VCD have a good loving relationship and ideally are still having close sexual contact. And a sense of humour helps as they can be fun to use!

The advantages of a VCD include the fact that it works for the majority of men who try it and effectively puts a man back "in charge" of his erections. And it takes away the feeling of powerlessness and inadequacy that ED often causes. It also can inspire natural erectile function, which may well be partly due to restoration of confidence in ability to perform on a psychological level. But VCDs have also been shown to improve circulation in the penis with regular use. The majority of couples have noticed not only an improvement in their sex life(10) but also an improved marital relationship.(16)

Disadvantages
Although the majority of patients and their partners find the VCD acceptable, there are some disadvantages, including: (10,17)

  • Lack of spontaneity.
  • Blockage of ejaculation.
  • Cool penis.
  • Penile bruising.
  • Cost.
  • Pain.
  • Pivotal effect caused by ring usage.

Reasons for discontinuation of the use of a VCD include: (10,17)

  • Return of erectile function.
  • Decreased sex drive.
  • Loss of partner.
  • Partner dissatisfaction.
  • Side-effects.
  • Switch to other forms of treatment.

Schedule two
Categories where prescription of VCDs are acceptable by the NHS are:

  • Diabetes.
  • Multiple sclerosis.
  • Parkinson's disease.
  • Poliomyelitis.
  • Prostate cancer.
  • Prostatectomy.
  • Radical pelvic surgery.
  • Severe pelvic surgery.
  • Renal failure treated by dialysis or transplant.
  • Single gene neurological disease.
  • Spinal cord injury.
  • Spina bifida.

Also, patients who have been receiving treatment for ED prior to 14 September 1998 and patients who suffer from severe distress.

The future of the use of VCDs
It has been postulated by some experts in the field that the use of a VCD, especially in patients susceptible to ED, such as diabetics, may increase blood flow.(17)

Although the VCD has been around for a long time for use in treating ED, on its own merits, it is also being used in conjunction with drug therapy, as a pre-drug treatment penile exerciser to increase circulation and to reduce tissue resistance to medication. Some success has also been achieved anecdotally in the author's clinic with the VCD as an enhancer of medications, if not totally effective alone, and a preliminary study supports this.(18)

Research also has been carried out on the use of VCDs as a treatment for Peyronie's disease, a condition that affects one in 100 men, whereby scar tissue builds up penile tissue, causing scarring and ED in some cases.(19)

Conclusion

The VCD still remains a relatively inexpensive, noninvasive treatment for ED and will, no doubt, remain an integral part of the armamentarium to treat, and possibly prevent, this condition for the foreseeable future.

References

  1. Kirby RS. BMJ 1994;308:957-61.
  2. Bancroft J, et al. Arch Sex Behav 1983;12:59-62.
  3. Reid K, et al. Lancet 1987:2:421-3.
  4. Padma-Nathan H, et al. World J Urol 1987;5:160-5.
  5. Wilson SK, et al. J Urol 1988;139:951-2.
  6. Nelson RP. J Urol 1988;139(1):2-5.
  7. Baum N. J Postgrad Med 1987;81(7):133-6.
  8. Hoffman JAS. External vacuum therapy for erectile dysfunction: an historical and clinical review. Australia: Osbon Medical Systems; 1996.
  9. Witherington R. J Urol 1989;141:320-2.
  10. Sidi AA, et al. J Urol 1990;144:1154-6.
  11. Turner LA, et al. J Sex Marital Ther 1991;17(2):81-93.
  12. Cookson MS, et al. J Urol 1993;149:290-4.
  13. Baltaci S, et al. Br J Urol 1995;76(6):757-60.
  14. Vrijhof HJ, et al. Br J Urol 994;74(1):102-5.
  15. Allen PA. A twelve month study of external vacuum devices for the treatment of erectile dysfunction. Birmingham: BAUS; 1994.
  16. Althof SE, et al. J Urol 1992;47(4):1024-7.
  17. Donatucci CF, et al. Int J Impotence Res 1992;4:149-55.
  18. Linh V Ho, et al. SSI. Boston University School of Medicine; 1999.
  19. Lue TF, et al. J Urol 1994;161:114.