Constriction ring as the exclusive treatment of veno-occlusive erectile dysfunction

J . CHEN, A. GREENSTEIN AND H. MATZKIN

Department of Urology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

Introduction

The results of the various reconstructive surgical treatments for veno-occlusive erectile dysfunction (ED) are unsatisfactory, with the reported long-term success rates being around 40±60%.1 There is general agreement that these operations should not be recommended as the treatment of choice in this patient population.2

Other therapeutic modalities such as vacuum constrictor devices or intracavernosal injections of vasoactive medications are occasionally not well accepted emotionally by the patients or their partners, and this leads to a high drop-out rate. A simple cost-effective device that will allow men with veno-occlusive ED to have satisfactory functional erections remains elusive. We conducted the present study to address the question whether a constriction ring alone without a vacuum device or the use of intracavernosal injections of vasoactive medications would answer this need.

Materials and methods

Eighteen patients evaluated for ED of at least 6 months duration and who had never undergone treatment for this condition were recruited from the erectile dysfunction clinic at the Tel Aviv Sourasky Medical Center. All study patients were diagnosed as having veno-occlusive ED after undergoing a detailed medical and sexual history and a physical examination conducted according to the NIH Consensus Conference on Impotence.3 They were healthy, relatively young men, who were able to reach full erection following spontaneous sexual stimulation but lost their erection before or during vaginal penetration or immediately afterwards, before reaching orgasm and ejaculation. All underwent RigiScan testing and dynamic colour duplex Doppler (B-K Medical, Gentofte, Denmark) with intracavernosal injection of a 0.5 cc mixture of papaverine 15 mg, PGE1 10 lg, and phentolamine 0.8 mg. Six patients also underwent dynamic cavernosometry and cavernosography.

Aim

We evaluated the efficacy of a commercially available rubber constriction ring as the first line in non-invasive treatment of veno-occlusive erectile dysfunction (ED).

Method and results

Eighteen subjects (mean age 33.8 years) with veno-occlusive ED used the band as sole treatment and graded their subsequent erection as satisfactory, partially satisfactory, or unsatisfactory. The study follow-up period was 2 years. After 1 month, 14/18 subjects could maintain an erection adequate for vaginal penetration. After 3 months of follow-up, the same quality of erections in 13 of these 14 participants persisted. After 24 months, 12 of the originally enrolled 18 patients continued to use only the constriction ring for overcoming their ED.

Following a discussion with the patients and their partners about the various available treatment options, the constriction ring was recommended as the preferred first choice approach. After obtaining signed informed consent, the men entered this prospective open study and were followed up for 2 years. Their average age was 33.8 years (range 18±59 years).

All patients used the Post-T-Vac,TM B-100 (Post-TVac Inc., Dodge City, KS, USA) type constriction ring. The rubber band size was adjusted to penis circumference at the ED clinic. Patients were instructed to release the rubber band from the ring holder and place it on the base of penis once they had achieved full spontaneous erection with adequate rigidity. They kept a diary at home in which they graded their erection and at each subsequent visit to the clinic they reported their evaluations of those erections and their ability to have intercourse with vaginal penetration.

The quality of the erections were graded as: satisfactory when penile rigidity during the erection allowed vaginal penetration in more than 90% of attempts at intercourse, partially satisfactory if penile rigidity during erection was not full but was sufficient for vaginal penetration and intercourse in more than 70% of the attempts, and unsatisfactory if penetration and intercourse were not possible. In addition, patients were asked to record their satisfaction with the use of the constriction ring (i.e. satisfactory or unsatisfactory for vaginal penetration and intercourse) or if they wish to explore other options, such as oral medication (Viagra), an intraurethral device (MUSE), intracavernosal injection, an external vacuum device, or the insertion of a penile prosthesis.

Results

All the patients responded to the intracavernosal injection by achieving a full erection for a short period of time (<10 min) during dynamic colour Doppler testing, as expected in veno-occlusive erectile dysfunction.

The measurement of peak systolic velocity in all patients was >35 mL sec±1, the diastolic velocity was >5 mL sec±1 and the resistivity index (RI) was <0.75. Each patient had a Rigi-Scan test score of more than 70%, but the duration of erection was <10 min.

After 1 month of using only the ring to overcome their veno-occlusive ED, 14/18 study subjects reported that they were able to maintain a full erection and rigidity throughout the entire time of sexual intercourse. The other four subjects were not satisfied and declared their interest in other treatments such as intracavernous injections. After 2 months of followup,

13/14 patients who continued in the study could have vaginal intercourse assisted by the constriction ring alone. Twelve subjects graded their penile rigidity during the erection as satisfactory, one subject graded his erection as partially satisfactory, and one described the use of the ring as unsatisfactory and wished to employ other treatments.

After 24 months, 12 subjects of the 14 who had enjoyed success with the constriction ring with erection adequate for sexual intercourse during the initial month of the study were using it with continuing success.

Discussion

Erectile dysfunction may be caused by vascular, endocrine, neurologic, psychogenic, or anatomic derangement or from a combination of all this factors.

The arsenal of treatment options available for patients with ED includes medical as well as surgical methods of therapy. In addition to the constriction ring, there are intracavernous pharmacotherapies, vacuum constriction devices, surgical procedures (penile vein ligation, arterial revascularization, and the insertion of a penile prosthesis) and recently introduced oral medications. Many of these remedies are often rejectedby the patients due to lack of efficacy, invasiveness or cost. Therefore, a simple cost-effective device that will allow men with veno-occlusive ED to have satisfactory functional erections will be welcome.

In this prospective study we evaluated and, for 24 months, followed patients who used the constriction ring as the sole treatment modality for venoocclusive ED. These men were younger than the usual population treated in an erectile dysfunction clinic. They had a clear-cut clinical presentation of venoocclusive erectile dysfunction, i.e. able to achieve full erection following spontaneous sexual stimulation but with the rigidity subsiding before, during, or shortly after penetration with no association with ejaculation.

Eighty-six percent of the patients who had employed the constriction ring successfully for 1 month continued to be satisfied with their erectile function. Furthermore, they reported not being interested in trying other treatments throughout the entire follow-up period. In other words, satisfaction with the use of the ring for a period of time as short as 1 month appeared to be sufficient to predict that the ring will adequately achieve the desired effect over longer periods of time. Our results are comparable to those reported in the literature using other therapeutic modalities. Hanash reported the success rate for the first choice goal-directed therapy in 400 patients with ED as being 60% (using mainly intracavernosal injections).4  Kim and McVary reported a long-term potency rate of 60% of patients with veno-occlusive ED who underwent surgical treatment.1 In contrast to the side-effects such as priapism, penile necrosis, or penile induration which are associated with surgery and orally or injected medications, none of our patients reported having suffered from any side-effects which could be associated with the use of the ring. It should be noted that complications such as penile Fournier's gangrene have been reported with the use of the constriction ring.5 However, we contend that adequate instruction in the use of the device will circumvent most complications.

We showed the constriction ring to be an adequate and cost-effective treatment for veno-occlusive ED. The cost of each ring in our country is US$20, and it can, of course, be frequently reused. In comparison, the cost of one vial of PGE1 is around US$30, one Viagra pill is US$15, one MUSE is US$20 and of a reusable external vacuum device is US$250. Moreover, the cost of one penile prosthesis, excluding the expenses involved in surgery, is US$1000±4500, depending upon whether it is semirigid or inflatable.

This study was conducted on a small cohort because the number of patients with pure veno-occlusive erectile dysfunction is itself relatively small. It is therefore impossible to draw strong conclusions from our study. However, our results appear very encouraging in this difficult treatment group. Patients satisfied with the use of the constriction ring after the first month can be expected to enjoy long-term satisfactory erections.

Conclusions

We propose that this device is a good non-invasive, simple and cost-effective treatment in this patient group an that its success during the first month is a good indication for the physician to encourage its continuing use.

Keywords: constriction ring, erectile dysfunction, veno-occlusion.

Accepted for publication 5 October 1999

Correspondence:

Juza Chen, Department of Urology, Tel Aviv Sourasky Medical Center, 6 Weizman Street, Tel-Aviv, 64239, Israel.

Acknowledgements

We thank Esther Eshkol for editorial assistance.

References

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2 Montague DK, Barada JH, Belker AMB et al. Clinical guidelines panel on erectile dysfunction: Summary report on the treatment of organic erectile dysfunction. J Urol 1996; 156: 2007±11.

3 Impotence. NIH Consensus statement, December. 1992; 7±9 10(4): 1±31.

4 Hanish KA. Comparative results of goal oriented therapy for erectile dysfunction. J Urol 1997; 157: 2135±8.

5 Theiss N, Hofmockel G, Frohmuller HGW. Fournier's gangrene in a patient with erectile dysfunction following use of a mechanical erection aid device. J Urol 1995; 153: 1921±2.