vacuum constriction devices for erectile dysfunction

VACUUM CONSTRICTION DEVICES FOR ERECTILE
DYSFUNCTION: A LONG-TERM, PROSPECTIVE STUDY OF
PATIENTS WITH MILD, MODERATE, AND
SEVERE DYSFUNCTION
TIMOTHY C. DUTTA AND JEAN FRANCOIS EID
ABSTRACT
Objectives. To evaluate, using a long-term, prospective study, the satisfaction rate, attrition rate, and
follow-up treatment of well-trained patients using an external vacuum erection device, the Osbon ErecAid
System, in the treatment of mild, moderate, and severe organic erectile dysfunction.
Methods. One hundred twenty-nine patients were assessed to determine the severity and cause of their
erectile dysfunction. Patients with organic erectile dysfunction who were interested in the Osbon ErecAid
received the device after thorough training. Patients received a follow-up questionnaire regarding satisfaction,
months of use, reasons for discontinuing, and further treatment.
Results. Our attrition rate was 65% overall and was lowest among patients with moderate erectile dysfunction
(55%). All patients with mild dysfunction discontinued use, and a large number (70%) of patients with
complete dysfunction also discontinued use. Of the patients who discontinued, most stopped treatment
early (median 1 month, mean 4 months) and 63% did not seek further treatment. Thirty-five percent of
patients were satisfied with the device and have continued to use it long term (mean 37 months).
Conclusions. Our study showed a lower success rate than previous reports. Patients who were satisfied with
the Osbon ErecAid continued to use it for long periods. Patients who were not satisfied dropped out very
quickly, and many did not seek further treatment. Patients with moderate erectile dysfunction had a higher
rate of success than patients with mild or severe erectile dysfunction. UROLOGY 54: 891–893, 1999.
© 1999, Elsevier Science Inc.
Erection-inducing vacuum constricting devices
(VCDs) were described as early as 1917, but
did not become widely used until the 1970s. 1 By
promoting penile blood engorgement with a suction
chamber and maintaining tumescence with a
constricting band, VCDs assist in achieving an
erection. The potential strengths of this therapy are
its nonmedical, noninvasive nature and its costeffectiveness.
The potential weaknesses include
the learning required to use it, complaints of lack
of full rigidity of the penis and lack of rigidity proximal
to the constricting band, and a sense of lack of
spontaneity because of the mechanical nature of
From the Department of Urology, New York Hospital-Cornell
Medical Center, New York, New York
Reprint requests: Jean Francois Eid, M.D., Department of Urology,
New York Hospital-Cornell Medical Center, 525 East 68th
Street, Box 29, New York, NY 10021
Submitted: October 13, 1998, accepted (with revisions): May
20, 1999
ADULT UROLOGY
the device. Numerous published reports exist that
describe this treatment as very effective. 2–7 As
newer treatments for erectile dysfunction emerge,
it is important to better determine for which patients
VCDs are appropriate, what outcomes to expect
from their use, and, for patients who fail, what
alternatives to choose. We conducted a long-term,
prospective study of patients who were well
trained in the use of the Osbon ErecAid VCD (Osbon
Medical Systems, Augusta, Ga). By stratifying
patients by severity of erectile dysfunction, it was
our intent to display any differences in success
rates among these groups. Furthermore, with excellent
and consistent training of all patients by an
Osbon representative, we believe that the patients
in our study had the best opportunity for success
with the VCD. With long-term follow-up, we proposed
to determine when patients would stop using
the VCD and for how long those who were
satisfied with it would continue its use.
© 1999, ELSEVIER SCIENCE INC. 0090-4295/99/$20.00
ALL RIGHTS RESERVED PII S0090-4295(99)00264-2 891

MATERIAL AND METHODS
PATIENT EVALUATION
Between 1990 and 1996, 146 patients were enrolled in our
Osbon study. These patients all presented to our clinic with a
complaint of erectile dysfunction. All patients completed a
detailed sexual function questionnaire at their initial office
visit. From this survey, the duration and severity of the erectile
dysfunction were determined.
The erectile dysfunction of patients whose penis had atrophy
with degenerative changes of the penile tissue and whose
penis was completely limp or became full but without hardness
was classified as complete. The erectile dysfunction of
patients who achieved sufficient hardness for intromission but
were unable to maintain their erection was classified as moderate.
The erectile dysfunction of those patients who could
penetrate and achieve orgasm was classified as mild.
Each patient was seen and evaluated by one of us (J.F.E.),
who took a detailed medical and sexual history. A complete
physical examination was conducted, as were studies of serum
testosterone and duplex Doppler ultrasound of the penile arteries
combined with intracavernous administration of prostaglandin
E 1. In this manner, all patients were diagnosed with
vascular, cavernosal, neurogenic, or hormonal erectile dysfunction.
Only patients with these organic diagnoses were included
in the study.
INSTRUCTION
Patients with a diagnosis of organic erectile dysfunction
were presented, in a nonbiased manner, with choices of no
treatment, VCD, injection, or implantation. All patients included
in the study chose the VCD as the first line treatment.
The Osbon VCD was the only device prescribed to limit variables
and because tutoring by an Osbon representative was
available. All patients received verbal instruction from an Osbon
ErecAid representative on the use of the VCD, viewed a
videotape, and received an individual demonstration. If the
patient achieved a satisfactory erection with the sales representative
in an office setting, the patient received a prescription
for the Osbon ErecAid System. Patients were then followed
up by one of us (J.F.E.) and obtained advice or
alternative treatments as necessary.
FOLLOW-UP
In late 1996, patients received a follow-up questionnaire by
mail. Those who did not respond or did not complete the
questionnaire entirely were followed up by telephone. Patients
who could not be reached were considered to have
dropped out of the study.
RESULTS
Of the 146 patients originally enrolled in the
study, 129 completed the patient questionnaire
and were included the analysis. The mean time of
follow-up was 37 months after receiving the Osbon
prescription. All but 11 patients included in the
study had filled their prescription more than 12
months before completing the follow-up questionnaire.
At the conclusion of the study, 84 patients
(65%) were no longer using the device (inactive),
and 45 patients (35%) were still using it (active).
Patient age and diagnosis were comparable between
the two groups. The mean age of active patients
was 66 years (range 52 to 78), compared
with 64 years (range 39 to 80) for inactive users.
FIGURE 1. Months of use from time of purchase until
discontinuing.
Diagnoses were very similar between the two
groups; the most common etiology was vascular,
followed by cavernosal, neuronal, and hormonal.
Nine of the patients (7%) had mild erectile dysfunction,
54 (42%) had moderate erectile dysfunction,
and 66 (51%) had complete erectile dysfunction,
as defined above. All 9 patients with mild
erectile dysfunction discontinued use of the VCD.
Patients with complete erectile dysfunction also
quit at higher rates (70% quit and 30% continued).
Patients with moderate erectile dysfunction were
the most likely to continue using the device (55%
quit and 45% continued). Fisher’s exact test for use
status as a function of severity indicated that the
percentage of patients who stopped was significantly
different across the severity levels (P
0.01).
Among inactive patients, the average number of
months before quitting was 4 months (median 1,
range 1 to 36) (Fig. 1). The three most common
reasons for stopping use were as follows: 48% (n
57) considered it ineffective, 20% (n 17) too
painful, and 24% (n 20) too cumbersome (Table
I). Additional reasons for drop out were as follows:
5 considered the erection to be artificial, which led
to a loss of desire, 2 reported loss of a partner, and
6 reported that their ability to obtain a natural erection
had been restored. Follow-up treatments for
the 84 patients who dropped out were as follows:
31% (n 26) received intracavernosal therapy, 6%
(n 5) received a prosthesis, and 63% (n 53)
chose to receive no further treatment (Table I).
COMMENT
Previous studies of VCDs have had varying satisfaction
rates. Some studies have shown high satisfaction
rates, 3,6–9 but other studies have shown
lower satisfaction rates. 1,10 Some researchers have
892 UROLOGY 54 (5), 1999

TABLE I. Reason for discontinuation and new
treatment among inactive patients
n (%)
Reason*
Ineffective 48 (57)
Cumbersome 20 (24)
Too painful 17 (20)
Lack of interest 5 (6.0)
Loss of partner 2 (2.4)
Problem resolved
New treatment
6 (7.1)
No new treatment 53 (63)
Injections 26 (31)
Surgery 5 (6.0)
* Patients were allowed to give two reasons.
argued that success rates are highly determined by
the degree of training. 11 We believe that we studied
the most motivated and best trained cohort of patients
clinically possible. All patients chose the
VCD as the first line therapy and received training
by watching a videotape and having an individual
demonstration with an Osbon representative. Despite
this, our overall failure rate was 65%. Most of
these patients quit early; the median time of drop
out was only 1 month (Fig. 1). These patients most
commonly quit because the device was found to be
ineffective, cumbersome, or painful.
The severity of erectile dysfunction was a significant
factor in drop-out rates. Patients with moderate
erectile dysfunction were the most successful.
All patients in our study with mild erectile
dysfunction discontinued use of the VCD. Patients
with complete erectile dysfunction also had low
success rates. Thus, the VCD was most useful to
patients with moderate erectile dysfunction (P
0.01).
Sixty-three percent of patients who were unsuccessful
with the VCD sought no further treatment.
In another study by our group, of patients receiving
intracavernosal injections, only 28% of patients
who discontinued injections did not seek further
treatment. 12 In the intracavernosal injection study,
52% of those patients who discontinued injections
opted for a prosthesis; only 6% in our VCD study
did. It appears that there may be different motivations
for patients seeking these different treatments.
The appeal of the VCD is largely that it is
noninvasive. Patients willing to give themselves injections
may be more willing to try other, more
invasive treatments, and patients who choose the
VCD may be less willing to try more invasive therapies.
This underscores the noninvasive strength
of the VCD.
Of the active patients in our study, these patients
had long-term success with the VCD. The average
duration of use for these patients was 37 months
(maximum 84). For these patients, the treatment
successfully provided a cost-effective, noninvasive,
nonmedical therapy. This clearly shows the importance
of the VCD as an option in the treatment of
organic erectile dysfunction. Again, the success
rates were highest for patients with moderate erectile
dysfunction. Moderate erectile dysfunction
was defined as achieving sufficient hardness for
intromission but being unable to maintain the
erection. Nearly half of these patients were satisfied
with the VCD.
CONCLUSIONS
The Osbon ErecAid provided successful longterm
treatment in 35% of patients overall. Our
study was the first report to stratify patients as having
mild, moderate, or severe erectile dysfunction.
Patients with moderate dysfunction had the highest
rates of success, and all patients with mild dysfunction
discontinued use of the VCD. Many patients
who were unsuccessful with the VCD did not
seek alternative treatments. The VCD remains a
viable noninvasive treatment for erectile dysfunction,
particularly for patients with moderate dysfunction.
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