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
1 Kim ED, McVary KT. Long-term results with penile ligation
for venogenic impotence. J Urol 1995; 153:655±8.
2 Montague DK, Barada JH, Belker AMB et al. Clinical
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3 Impotence. NIH Consensus statement, December. 1992; 7±9
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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.
