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Vacuum therapy in erectile dysfunction—science and clinical evidence

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Vacuum therapy (VT) utilizes negative pressure to distend the corporal sinusoids and to increase the blood inflow to the penis. Depending on its purpose, VT could be used as vacuum constriction device (VCD), with the aid of an external constricting ring which is placed at the base of penis to prevent blood outflow, maintaining the erection for sexual intercourse. Also, as a vacuum erectile device (VED), without the application of a constriction ring, just increases blood oxygenation to the corpora cavernosa and for other purposes. The emerging of phosphodiesterase 5 inhibitors (PDE5I) for the treatment of erectile dysfunction (ED) eclipsed VCD as therapeutic choice for ED; however, widespread usage of VED as part of penile rehabilitation after radical prostatectomy and other purposes rekindle the interest for VT. The underlying hypothesis is that the artificial induction of erections shortly after surgery facilitates tissue oxygenation, reducing cavernosal fibrosis in the absence of nocturnal erections, and potentially increases the likelihood of preserving erectile function. Due to its ability to draw blood into the penis regardless of nerve disturbance, VED has become the centerpiece of penile rehabilitation protocols. Herein, we reviewed the history, mechanism, application, side effects and future direction of VT in ED.
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REVIEW
Vacuum therapy in erectile dysfunction—science and clinical
evidence
J Yuan
1
, AN Hoang
1
, CA Romero
1
, H Lin
2
, Y Dai
2
and R Wang
1
1
Division of Urology, University of Texas Medical School at Houston, Houston, TX, USA and
2
Affiliated Drum Tower
Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu Province, China
Vacuum therapy (VT) utilizes negative pressure to distend the corporal sinusoids and to increase
the blood inflow to the penis. Depending on its purpose, VT could be used as vacuum constriction
device (VCD), with the aid of an external constricting ring which is placed at the base of penis to
prevent blood outflow, maintaining the erection for sexual intercourse. Also, as a vacuum erectile
device (VED), without the application of a constriction ring, just increases blood oxygenation to the
corpora cavernosa and for other purposes. The emerging of phosphodiesterase 5 inhibitors (PDE
5
I)
for the treatment of erectile dysfunction (ED) eclipsed VCD as therapeutic choice for ED; however,
widespread usage of VED as part of penile rehabilitation after radical prostatectomy and other
purposes rekindle the interest for VT. The underlying hypothesis is that the artificial induction of
erections shortly after surgery facilitates tissue oxygenation, reducing cavernosal fibrosis in the
absence of nocturnal erections, and potentially increases the likelihood of preserving erectile
function. Due to its ability to draw blood into the penis regardless of nerve disturbance, VED has
become the centerpiece of penile rehabilitation protocols. Herein, we reviewed the history,
mechanism, application, side effects and future direction of VT in ED.
International Journal of Impotence Research (2010) 22, 211–219; doi:10.1038/ijir.2010.4;
published online 22 April 2010
Keywords: vacuum constriction device; vacuum erectile device; erectile dysfunction; penile
rehabilitation; radical prostatectomy
Introduction
Vacuum therapy (VT) uses negative pressure to
distend the corporal sinusoids and to increase blood
inflow to the penis. If a constricting ring is used, VT
would be categorized as a vacuum constriction
device (VCD); in this setting, an external constrict-
ing ring is placed at the base of the penis to prevent
blood outflow from the corpora cavernosa, and an
erection is maintained for sexual intercourse. A
vacuum erectile device (VED) is the use of VT
without a constrictive ring, with the objective of
increasing blood oxygenation in the corpora caver-
nosa, among other reasons. As a non-invasive,
effective, safe, drug-free and cost-effective erectile
dysfunction (ED) treatment, VCD was gradually
accepted by the urological community and was
finally recommended as an alternative for treatment
of ED by the American Urological Association in
1996.
1
With the great success of phosphodiesterase-
5 inhibitors (PDE
5
I) for treatment of ED, VCD lost its
luster. However, when PDE
5
I limitations were
shown and VED use expanded, interest about VT
has been rekindled. This review addresses the
applications of VT for ED, penile rehabilitation
(PR) and other urological conditions.
History
In 1874, John King, an American physician, stated
that ‘when there is impotency with a diminution of
the size of the male organ, the glass exhauster should
be applied to the part’. What he referred to was
simply a vacuum device capable of producing an
artificial erection. However, it failed to maintain the
erection once the glass exhauster was taken off the
penis.
2
It was not until 1917, when a patent was
granted to Otto Lederer for his ‘surgical device to
produce erection with vacuum’, that the concept of a
‘compression’ ring to be used in conjunction with the
Received 2 December 2009; revised 15 January 2010;
accepted 14 February 2010; published online 22 April
2010
Correspondence: Dr R Wang, Division of Urology, Uni-
versity of Texas Health Science Center at Houston, 6431
Fannin St, MSB 6.018, Houston, TX 77030, USA.
E-mail: Run.Wang@uth.tmc.edu
International Journal of Impotence Research (2010) 22, 211–219
&
2010 Macmillan Publishers Limited All rights reserved 0955-9930/10
www.nature.com/ijir
vacuum device was introduced.
3
Since then, several
patents had been granted to modifications,
4,5
but the
credit for the popularization of VCD is generally
given to a Georgian entrepreneur, Geddins D Osbon,
who developed his ‘youth equivalent device’ in the
1960s. It was reported that he personally used the
device for more than 20 years without device failure
while popularizing and perfecting the device. His
effort culminated in the first marketed VCD device,
Erecaid,
6
to receive the US Food and Drug Admin-
istration (FDA) approval in 1982.
7
Despite this, the
device faced strong skepticism among the medical
community and patients. Instrumental in overcoming
these skepticisms and popularizing the device were
the early works of Nadig
8
and Witherington
9
in
establishing its efficacy and safety profiles. It was
thought to have finally gained acceptance by the
medical community with Lue’s commentary in the
Journal of Urology: ‘I recommend a vacuum constric-
tion device to all of my patients (except those with
coagulation disorders and sickle cell disease) as the
initial medical option’.
10
As more evidence emerged,
the American Urological Association ultimately
recommended VCD as one of three treatment alter-
natives for organic ED.
1
Devices and mechanisms
Currently, there are over dozens of commercially
available VCDs, that is, Timm Medical Technologies
(Eden Prairie, MN, USA), Mission Pharmacal (San
Antonio, TX, USA), Encore (Louisville, KY, USA),
Mentor (Santa Barbara, CA, USA) and Post-T-Vac
(Dodge City, KS, USA). All of these devices share the
same basic mechanics since its original develop-
ment. They all comprise three components: a
vacuum cylinder, a battery or manually operated
vacuum pump and constriction rings of varying
sizes (Figure 1).
11
Some of the latest models have a
pressure release valve designed to prevent penile
injury from excessive negative pressure.
12
It is
reported that single-handed devices are more desir-
able to novice users.
13
Usage begins with placing the correct constriction
ring over the open end of the vacuum cylinder. A
copious amount of a water-soluble lubricant is then
applied to the base of the penis to create a tight seal
once the vacuum cylinder is placed over. Negative
pressure (100–225 mm Hg) generated either by hand
or a battery-operated pump is then applied to create
an artificial erection.
14
Once the desired state of
erection is achieved, the constriction ring is dis-
placed onto the base of the penis to maintain the
erect state. Variable vacuum cylinders and constric-
tion rings are available to select for those that are
most comfortable and effective. The vacuum cylin-
ders could then be removed and the patient may
have intimacy. Patients can become proficient with
the device within 5 days
15
or four practice sessions.
9
The time required to achieve an adequate penile
erection ranges from 30 s to 7 min,
9,16
and many
manufacturers advise patients to pump for 1–2 min,
release and then pump again for 3–4 min.
7
Unlike the normal physiology of penile erection
in which a complex interplay between neural
inputs, vascular patency and hormonal secretion is
required, tumescence from VCD resulted from
passive flow of mixed venous and arterial blood.
17,18
Broderick et al.
17
showed by color Doppler ultra-
sound that the negative pressure transiently drew
arterial blood into the sinusoidal spaces of the
cavernosal tissues, increasing its diameter nearly
two-fold. The change in diameter owed itself to both
intracorporal and extracorporal distention. The
constriction ring placed at the base of the penis
prevented the venous outflow. Color Doppler ultra-
sound performed after the placement of constriction
ring, however, showed no arterial inflow into the
penis.
17
Blood gas analysis showed ischemia after
30 min of applying constriction ring.
18
This led to
the recommendation that the constriction ring
should not be left on for 430 min to prevent
ischemic injury to the penis. Compared with
naturally occurring erections, VCD-derived erec-
tions are perceived differently by both the man
and their partner. The ‘erection’ looks dusky and
feels cooler than normal, with increased volume
distally, especially at the glans penis.
7
VT in erectile dysfunction–VCD
Indications
VCD therapy can be applied successfully for nearly
all etiologies of ED;
8
although its success depends
Figure 1 Three types of human vacuum devices.
Vacuum therapy in erectile dysfunction
J Yuan et al
212
International Journal of Impotence Research
on appropriate instruction and practice.
19
More than
90% of men will experience functional erection
with VCD therapy with adequate practice.
9
It is currently a second-line therapy along with
intracavernosal self-injection and intraurethral ther-
apy with vasoactive substances.
20
It is widely
believed that VCD therapy is more acceptable among
elderly patients with occasional sexual intimacy, as
younger patients may show limited acceptance
because of its perceived ‘unnatural’ erection.
21
Chen
et al., conversely, reported that VCD therapy
remained the preferred treatment option among
couples who had achieved satisfactory erections
with either VCDs and PDE
5
I.
22
VCD may also be used in conjunction with other
therapies for synergistic effects. It has been reported
that VCD therapy could be combined with PDE
5
I,
23
intracavernosal self-injection,
24,25
intraurethral ther-
apy,
26
psychotherapy
27
and even penile prosthesis.
28,29
Contraindications
Contraindications to the use of VCD are few and
primarily include patients with a tendency for
spontaneous priapism or intermittent prolonged erec-
tions, and those with severe penile anomalies (either
congenital or acquired).
7
There are some relative
contraindications, which can be overcome by educa-
tion and precautious care, such as cultural taboo,
cervical or high-thoracic spinal cord injuries, neuro-
logical disease or degenerative joint diseases with
poor manual dexterity.
30
Patients with bleeding dis-
orders or those on anticoagulation therapy are
considered at high risk to develop petechiae, eechy-
mosis or hematoma;
7
however, it was shown that the
risk did not exceed that of the general population.
31
Clinical results
VCDs, unlike PDE
5
Is, have not had to undergo strict
clinical trials to show their safety and efficacy before
their widespread usage. A review of literature
consists largely of single-center observational series,
collection of small prospective clinical trials and
commercial databases. Despite the paucity of data, a
wealth of clinical experience is available, although
with big variability in the clinical efficacy of VCD
therapy. These data are present in Table 1.
Nadig et al. were the first to provide objective data
regarding penile rigidity obtained using VCDs. It
was found that buckle pressures of 454 g (the
minimal criterion for rigidity used by many sleep
laboratories) were achieved in 27/35 (77%) pa-
tients.
8
Bosshardt and co-workers showed that a
nocturnal penile tumescence rigidity of 80% (70%
being sufficient for intercourse)
40
was the norm after
6 months in their group of 26 patients. They also
showed that induced ischemia could result after
30 min of applying the constriction rings. This led to
the recommendation that the constriction ring
should not be left on for 430 min to prevent
ischemic injury to the penis.
18
The effectiveness of VED has been established for
different causes of ED. For those with arteriogenic
ED, VCD therapy achieved the efficacy and satisfac-
tion rates of 67 and 84%, respectively.
37
For the
corporeal veno-occlusive dysfunction ED, Kolettis
et al.
38
reported a 56% satisfaction rate. For diabetic
ED, Arauz-Pacheco et al.
41
and Bodansky et al.
42
reported successful rates of 75 and 58%, respec-
tively. No severe side effects were reported. For
spinal cord injury-induced ED, an impressive 85%
successful rate was achieved with minor side
effects.
43
The largest patient group (34 777 cases)
was reported by Lewis and Witherington
7
who used
the VCD data from Osbon data bank with satisfac-
tion rates 65–83%; however, only 17% (5847) cases
had enough information to evaluate. Conversely,
Vrijhof et al.
36
and Sidi et al.
16
reported much lower
satisfaction rates, 50 and 68%, respectively. More
dramatically, Dutta et al. reported only 35% satisfac-
tion rate, with an attrition rate of 65%.
39
It is
Table 1 Efficacy of VCDs
Authors Year
published
Study
design
Enrollee
(mean follow-up)
Results
Nadig et al.
8
1986 Prospective 35 (8–22 months) 490% achieved adequate erections. 80% use regularly
Witherington
9
1989 Retrospective 1517 (8.6 months) 92% good erection
Sidi et al.
16
1990 Prospective 100 (7.9 months) 68% satisfaction rate
Cookson et al.
32
1993 Retrospective 216 (29 months) 70% use regularly. Quality of erection plus satisfaction 490%
Segenreich et al.
33
1993 Prospective 150 (25 months) 75% achieved adequate erection. 490% satisfaction rate
Blackard et al.
34
1993 Prospective 45 (?) 69% satisfaction rate
Meinhart et al.
35
1993 Prospective 74 (3 weeks) 27% satisfaction rate
Vrijhof et al.
36
1994 Prospective 67 50% achieved adequate erection
Baltaci et al.
37
1995 Retrospective 61 (12.8 months) 480% satisfaction rate. 67% effectiveness rate
Bosshardt et al.
18
1995 Prospective 30 (6 months) Quality of erection 80%
Kolettis et al.
38
1995 Prospective 50 56% satisfaction rate. An acceptable treatment mode for CVOD
Lewis et al.
7
1997 Retrospective 5847 (?) 65–83%
Dutta et al.
39
1999 Prospective 129 (37 months) High attrition rate (65%). 35% satisfaction rate
Abbreviations: CVOD, corporeal veno-occlusive dysfunction; VCD, vacuum constriction device.
Vacuum therapy in erectile dysfunction
J Yuan et al
213
International Journal of Impotence Research
believed that the huge discrepancy of satisfaction
rates may be attributed to patient selection and
patient education.
Complications
The use of VCD is usually well tolerated with mostly
mild side effects (Table 2). The most common side
effects include numbness, pain, penile bruising or
petechiae.
9,32,37,44–46
Due to the constriction
rings, painful ejaculation or sensation of trapped
ejaculate has also been commonly reported.
7,9
Other
rare complications such as leg spasms, testicular
migration, urethral varicosities/bleeding have been
reported.
47
Major complications like Peyronie’s
disease, penile skin necrosis, penile gangrene
and Fournier’s syndrome have been reported anec-
dotally.
47,48–52
VT in penile rehabilitation—VED
Introduction
Prostate cancer is the most common solid-organ
cancer among men and one of the leading causes of
death.
53
With early detection and radical prostatect-
omy (RP), the 15-year overall actuarial cancer-
specific survival rate has reached 90%.
54,55
Unfortu-
nately, RP is associated with several quality-of-life
side effects, mainly urinary incontinence and
ED.
56,57
With improvements in technique and the
use of robotic-assisted procedures, incontinence
rates have reduced to an acceptable level.
58–61
However, the same cannot be said for ED, as the
incidence of ED after RP ranges from 10 to 100%.
62
In an attempt to improve patients’ quality of life
after RP, PR is now widely applied in clinical
practice.
55,63–65
Currently, PR methods include the
use of PDE
5
I, intracavernosal self-injection/intraur-
ethral suppositories, VED or a combination of
different therapy modalities.
55,63–65
Pathophysiology
Erectile function (EF) becomes impaired immedi-
ately after RP secondary to cavernous nerve damage
during surgery, resulting in neuropraxia.
66
Even
with the most meticulous nerve-sparing dissection,
some degree of neuropraxia is unavoidable because
of the close proximity of the nerves to the prostatic
gland. These nerves tend to recover slowly, and it
may take as long as 3 years for them to return to a
new baseline functional status.
58
Absence or de-
creased erection and penile size ensue before
recovery of the cavernous nerve.
57,67
A reduction
in arterial inflow has also been reported due to
ligation of the accessory internal pudendal arteries
during RP.
68,69
The combination of nerve damage
with decreased arterial inflow may cause penile
tissue hypoxia leading to apoptosis and collagen
deposition, which ultimately results in venous leak,
which in turn, has been linked to the pathophysiol-
ogy of ED after RP.
70–79
As nerve recovery requires
time, it is hypothesized that VED may bypass the
neuropraxic period by directly dilating the caverno-
sal arteries, therefore, overcoming hypoxia and
preventing apoptosis and fibrosis before the func-
tional recovery of the cavernous nerve.
Laboratory and clinical evidence
VED, as PR modality, simulates natural erection and
allows reoxygenation of the penis.
80
There has been
growing evidence to support this. Blair et al.
81
documented that sub-atmospheric pressure induces
an initial increase in arterial inflow in the forearm of
healthy volunteers; Greenfield and Paterson
82
further showed a vasodilation effect on the arteries
of the forearm in volunteers exposed to a sub-
atmospheric pressure of 150 to 200 mm Hg,
which is similar to the pressure used in VED.
14
Diederichs et al.
83
noticed that negative pressure
induces expansion of penile tissue followed by
increase in blood flow in primates; the authors
believed that the increased blood flow was arterial
inflow. Broderick et al.
17
showed that a transient
vacuum application increases the peak flow velocity
of the cavernous arteries in humans. Donatucci and
Lue
84
further determined that chronic VED usage
increases cavernous arterial flow in men with mild
vasculogenic ED as measured using a duplex
ultrasonograph. Bosshardt et al. performed blood
gas analysis before VED application, immediately
after the application of a constriction ring and
repeated blood gas analysis 15 and 30 min later
with the constriction ring in place in ED patients.
This test showed that the mean O
2
saturation of
corporal blood immediately after VED-induced
erection was 79.2%, which translates as arterial
and venous contributions of flow of 58 and 42%,
respectively. In addition, after 30 min of continuous
application of a constriction ring, blood gas analysis
showed ischemia of the penile blood.
18
This is the
rationale for the use of VED as PR modality, instead
of VCD. Recently, Mu
¨ller et al.
85
applied hyperbaric
oxygen therapy on a bilateral cavernous nerve crash
rat model and showed that hyperbaric oxygen
Table 2 Complications of VCDs
Most common Rare
Penile discomfort/pain Penile hematoma
Penile coldness Penile hyper-pigmentation
Penile numbness Penile skin necrosis
Petechia or bruising Urethral bleeding
Ecchymosis Peyronie’s disease
Inability to ejaculate Penile gangrene
Pain on ejaculation Fournier’s syndrome
Abbreviation: VCD, vacuum constriction device.
Vacuum therapy in erectile dysfunction
J Yuan et al
214
International Journal of Impotence Research
therapy improved the preservation of EF. To explore
the molecular mechanism of VED, a rat-specific
VED, which simulates human VED, was success-
fully created and applied on a bilateral cavernous
nerve crash model by our group.
86
Our preliminary
data indicated that daily VED therapy significantly
improved the intracavernosal pressure/mean artery
pressure ratio, preserved penile length and girth,
decreased the level of hypoxia-inducible factor-1a,
transforming growth factor-b1, collagen and apopto-
sis, and increased the level of eNOS and a-smooth-
muscle actin.
87
The latest PR trials are summarized in Table 3.
88
Most trials used PDE
5
I to preserve penile sexual
health. One limitation of PDE
5
I is its requirement of
intact nerves to produce nitric oxide for proper
function. There have been theories that PDE
5
I may
work through a separate, neuron-independent en-
dothelial cell mechanism; however, it is still
unproven.
80
The direct mechanism of VED circum-
vented this limitation. Given its low complication
rate and relatively high compliance rate, along with
being the only modality that preserves penile length,
VED is an ideal choice as PR after RP
80
or other
pelvic injuries.
97,98
Munding et al.
99
documented that up to 48% men
had considerable shortening of the stretched penile
length (greater than 1.0 cm) at 3 months after RP.
Savoie et al.
100
found that nearly 20% of men who
undergo RP experience a penile length loss greater
than 15%. Gontero et al.
101
followed 126 men who
had undergone RP and measured penile length
before surgery, at the time of catheter removal, and
then at 3, 6 and 12 months. They found that the
greatest amount of shrinkage occurs in the immedi-
ate postoperative period, although shortening con-
tinues at a lesser rate throughout the entire study
period. They also found that a return of EF, defined
as an International Index of Erectile Function (IIEF)
of 15, and a nerve-sparing technique during RP,
mitigated penile shaft shrinkage. Several studies
looking at the efficacy of VED in preserving EF have
also examined preserved penile length as a second-
ary endpoint.
Raina et al.
92
randomized 109 post-NSRP patients
to early VED daily usage (group-1, n¼70) versus no
erectogenic aid (group-2, n¼35). The participants
were followed by the Sexual Health Inventory for
Men (SHIM) score. The secondary endpoints in-
cluded compliance, changes in penile circumfer-
ence or length, return of natural EF and ability for
vaginal intercourse. At the end of the 9-month
follow-up, 80% (60/74) of those in group-1 were
able to have sexual intercourse using the device,
with a satisfaction rate of 55%. Nineteen patients
reported return of natural erections and 17 had
erections sufficiently firm for vaginal penetration.
Conversely, only 37% (13/37) of the patients in
group-2 regained natural erections. When evaluating
for secondary endpoints, among those who used the
device regularly, only 23% (14/60) reported a
decrease in penile length and girth, whereas 22/35
Table 3 Summary table of penile rehabilitation trials
Authors Year
published
Treatment regimen Study design Enrollee Results
Schwartz et al.
89
2004 QOD PDE
5
I Prospective 21 No loss of smooth muscle in 50-mg group, gain
of smooth muscle in 100-mg group
Bannowsky et al.
90
2008 Daily PDE
5
I Prospective,
randomized
control
41 Treatment group has significantly higher IIEF
and higher spontaneous erection rates
Mccullough et al.
91
2008 Daily PDE
5
I Prospective,
randomized,
placebo
control
54 Treatment group had higher return of rigidity,
higher rate of spontaneous erections
Raina et al.
92
2006 Daily VED Prospective,
randomized
control
109 Improved sexual satisfaction, higher rate of
spontaneous erections
Ko
¨hler et al.
93
2007 Daily VED (10 min),
immediate versus
delayed
Prospective,
randomized
28 Delayed use of VED did not affect sexual satisfaction
once use began. No statistical significance in
penile shrinkage once VED started
Montorsi et al.
94
1997 ICI 3 times weekly Prospective,
randomized
control
30 Higher percentage of treatment group having
spontaneous erections
Mulhall et al.
95
2005 ICI or PDE
5
Ito
achieve erections
3weekly
Prospective,
control
132 Treatment group had 2.7 times the rate of spontaneous
erections, statistically higher IIEF scores
Nandipati et al.
96
2006 Daily PDE
5
I and
ICI 2–3 times weekly
Prospective 22 Assisted early sexual activity and satisfaction.
Addition of PDE
5
I allows lower dose of ICI
Abbreviations: ICI, intracorporal injection; IIEF, International Index of Erectile Function; PDE
5
I, phosphodiesterase inhibitor; VED,
vacuum erectile device.
Source: Hinh P and Wang R: Overview of Contemporary Penile Rehabilitation Therapies. Advances in Urology, 2008.
Vacuum therapy in erectile dysfunction
J Yuan et al
215
International Journal of Impotence Research
(60%) patients in the control group complained of
penile shrinkage. This result was confirmed by
Dalkin et al. who administered VED therapy to 39
men after RP for 90 days after catheter removal.
102
In
their study, 97% of compliant men maintained their
preoperative stretched penile length; shrinkage was
defined as X1 cm. The authors concluded that early
usage of VED facilitates early return of spontaneous
EF, early resumption of sexual life resulting in
spousal satisfaction and preservation of penile
length and size.
Other authors have investigated the timing of VED
therapy to maximize its benefits. Ko
¨hler et al.
93
randomized 28 patients undergoing RP to early VED
use (group-1, n¼17) and delayed VED use (group-2,
n¼11). Group-1 was instructed to use VED daily,
starting at 1 month after RP for two consecutive
5-min periods. Group-2 was instructed to use VED,
as many times as desired, starting at 6 months after
RP. These men were followed using IIEF scores. At a
follow-up of 3 and 6 months, group-1 had a
statistically higher IIEF score than group-2. Beyond
6 months, when group-2 began using VED therapy,
there was no statistical difference in IIEF scores
between both groups. When evaluating for penile
shortening after RP, group-1 did not experience any
significant penile length reduction; whereas group-2
experienced considerable shrinkage at 3 months
(mean loss 1.87 cm) and 6 months of follow-up
(mean loss 1.82 cm). However, when group-2 began
using VED therapy, the mean penile length loss
decreased to 1 cm. The authors concluded that early
VED therapy after RP helps to improve early sexual
function and preserve penile length.
Solid evidence that VED daily rehabilitation
preserves penile length and EF has been scattered;
however, a multicenter, randomized study with
objective criteria and long-term follow-up is still
needed.
VT under other urological conditions
In addition to its applications for ED and PR, VT
has been expanded to other urological conditions.
VED has been regarded as an initiator and enhance-
ment of other ED therapies. Bellorofonte et al.
103
showed a synergistic action between intracavernosal
vasoactive agents and VT. John et al.
26
combined
VED with intra-urethral prostaglandin E1 to eliminate
the need for constriction ring, with 100% successful
rate in 19 patients. Cecchi et al.
104
evaluated
VT with topical minoxidil in 18 patients and
found that the combination enhanced the erec-
tion quality, reduced the time of device application
and avoided 67% (12/18) the need for constrictive
rings.
VED has also been used to preserve or restore
natural potency. Oakley et al.
11
speculated that VED
usage may delay the onset of intractable impotence
in high-risk groups, such as those with diabetes and
dyslipidemia. Colombo et al.
105
showed that daily
VED with or without weekly intracavernosal papa-
verine (20 mg) injection for 6 months showed
significant improvement in spontaneous erectile
ability (VED only: 54% (14/26 patients);
VED þpapaverine: 65% (17/26 patients)). In addi-
tion, VED therapy has been shown to have penile
length preservation effect in both non-NSRP and
NSRP.
92
VED has also been successfully used in
patients after penile prosthesis removal. Moul and
Mcleod
106
reported 91% (10/11 patients) satisfac-
tory erection and successful intercourse with the
same or better length and circumference, compared
with the previous natural erection. The authors
attributed the prevention of penile scarring and
shortening to the gradual resolution of corporeal
scarring, with progressively improved blood flow
into corporeal sinuses by the VED therapy. Lue and
El-Sakka
107
have reported that chronic intermittent
stretching with VED successfully lengthened the
shortened penis due to severe Peyronie’s disease
after venous grafting in three patients. Lastly,
anecdotal evidence from Oakley et al.
11
indicated
that VED alone improved the size of both the flaccid
and the erect state of the microphallus. However, a
program of penile stretching with VED showed no
statistically significant difference after 6 months of
therapy; although it showed a 30% rate of patient
satisfaction, probably due to psychological effect.
108
Some VED derivatives have been invented.
Gus’kov
109
in 2003 reported a combination of the
vacuum effect along with vibration—the vibrova-
cuum fallostimulator named ‘Sanos’. The author
claimed that this new device reduced the exposure
of the penis to the vacuum effect, thus preventing
edema, hemorrhage and necrosis of the penile skin.
He also claimed that this had an efficacy rate of
92.1% among 330 patients; however, no further
confirmatory report has been found. Another ver-
sion of VED is the EROS-CTD (Clitoral Therapy
Device; UroMetrics Inc., St Paul, MN, USA), the
only FDA approved mechanical treatment for female
sexual dysfunction. This device causes clitoral
vascular engorgement using a vacuum system.
110
Billups et al.
111
reported that a 3-month Eros
therapy improved sensation (90%), vaginal lubrica-
tion (80%), orgasm (55%), and sexual satisfaction
(80%) without adverse effects in 20 women with
female sexual dysfunction. Wilson et al.
112
con-
firmed the results in 10 women with female sexual
dysfunction. Schroder et al.
113
found that the Eros
therapy significantly improved patients’ arousal,
lubrication, orgasm and desire among 11 women
with cervical cancer treated with radiation therapy
and sexual arousal and/or orgasmic disorder. Bill-
ups et al. showed similar results in terms of vaginal
lubrication (92%) and orgasm (62%) for 13 women
with female sexual dysfunction and diabetes.
114
Many women in this study also noted that after
Vacuum therapy in erectile dysfunction
J Yuan et al
216
International Journal of Impotence Research
using the Eros therapy several times per week over a
2- to 3-month period, they continued to have
improved vaginal lubrication, genital sensation or
orgasms even without the device.
Future prospects
VCD therapy is an established alternative for ED
therapy when PDE
5
I therapy failed, contraindicated
or became unaffordable. As a variation of VCD, VED
has been expanding to more urological conditions
that are difficult to manage. The most striking use of
VED is penile rehabilitation after RP or other pelvic
injuries. As data are increasingly being accumulated
from clinical and basic research, the movement is
gaining support to establish VED therapy as the
centerpiece of PR protocol for post-prostatectomy/
pelvic injuries. VT in general will be an indispen-
sable modality in the urological armamentarium for
the management of ED and related conditions.
Conflict of interest
The authors declare no conflict of interest.
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... When they are contracted an increase of the local blood flow to the pelvic region is verified. This process seems to lead to a release of NO to the penis, acting on endothelium vasodilation and dependent on the flow, increasing in oxygen supply to the penile tissue and keeping the erectile tissue healthy (23, 52, 58-60). ...
... Following this same point of view, the vaccum therapy could also provide oxygen supply generated by negative pressure that distends the corporal sinusoids and increases the blood inflow to the penis. The vaccum therapy could be combined with anothers therapies for ED, as pelvic floor muscles exercices (kinesiotherapy) and oral therapies (medications) (52). ...
... In addition to ED, RP has been also associated with a 50% weaking of the orgasmic sensation (51). Treatment regimens currently available for ED include psychotherapy, sex therapy, oral pharmacological agents, androgen replacement therapy, intraurethral therapy, intracavernosal injections, several procedures related to the physiotherapy and surgery (23, 34, 45, 46, 48, 52). Dorey et al, 2009 (23) has reported that contracting the pelvic floor muscles during sexual activity has been also recommended to the patient to maintain or improve erectile strength. ...
Article
Full-text available
Advances in medical science procedures and their utilization in the field of oncology improved the survival of patients. In consequence, these advances have influenced the practice of physiotherapy. Physiotherapists utilize physical agents with the objective to enhance the health, welfare and quality of life and thus they can play important role in the management and rehabilitation of patients with prostate cancer (PCa). Urinary incontinence (UI) and erectile dysfunction (ED) are effects normally associated with the radical prostatectomy and radiotherapy due to the damage of the muscles of the pelvic floor (MPV). The aim of this work is to present findings related to the PCa and how the physiotherapist can guide the patient in relation to the knowledge and understanding of the anatomic structures related directly with the pelvic floor, the correct breathing and the perception of the MPV, as other muscles of the pelvis. Interventions of the physiotherapy will re-train the muscles of the pelvis by improving the active retention strength of the MPV in order to overcome the insufficiency (mainly the UI and ED) of the injured muscles. In conclusion, it is suggested to consider and to offer to the PCa patients the techniques related to the physiotherapy before and after the treatment.
... [1] The vacuum pump uses negative pressure to increase blood flow to the penis by distending the corporeal sinusoids. [2] Constriction rings can be used to maintain an erection for penetration. [1] It was previously named as a vacuum constriction device, vacuum tumescence device, and so on. ...
Article
Patients with cardiovascular disease (CVD) are prone to developing erectile dysfunction (ED) due to the common risk factors and pathogenesis underlying ED and CVD. As a result, ED affects nearly 80% of male patients with CVD. The efficacy of phosphodiesterase type 5 inhibitors, vacuum erection devices or intracavernosal injection of vasodilating agents is well established in the treatment of ED; however, their use is limited. Low energy shock-wave therapy (LESWT) is a novel modality that may become a causative treatment for ED. The review aims to assess the efficacy and safety of LESWT in the treatment of ED in men with CVD.
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About 30 % of patients receiving PDE5-Inhibitors for the treatment of erectile dysfunction do not respond to oral drug. It could depend on lack of correct information for drug use, lack of appropriate follow-up, presence of comorbidities, unrealistic patient expectations, incorrect diagnosis, performance anxiety and problematic relationships. So, before prescribing to patients a second line therapy, it is mandatory to carefully check if patient is taking PDE5-inhibitors in the right way and with an adequate sexual stimulation, if the medication taken is a licensed one, if patient is affected by hypogonadism and therefore needs a testosterone replacement therapy or if patient could benefit from the treatment of comorbidities. In addition, switching to another PDE5-inhibitor or a combination therapy with long-acting and short-acting PDE5-inhibitors could be effective strategies in non-responders. If patients are still not-responders, a second line therapy could be suggested. Intracavernosal injections (ICI) with vasoactive agents (prostaglandins, papaverine, phentolamine, vasoactive intestinal polypeptide) are the most widely used second line therapy and their effectiveness is high (>70 %). Nevertheless, the drop-out rate of these therapy is still high due to willing of a definitive and permanent therapy, discomfort in self-injection, lack of spontaneity in sexual relationship and stop of sexual activity. Use of vacuum device is a valid treatment too for erectile dysfunction with a success rate of more than 90 % and could be an alternative method in older patients in a stable relationship. Treatment with alprostadil cream with a permeation enhancer in patients affected by erectile dysfunction of all etiology and physical therapy with low-intensity shockwave in patients affected by vasculogenic erectile dysfunction are very promising strategies but to date no specific recommendation could be given for their use. Combination of different second line therapies or combination between a second line treatment and a PDE5-inhibitor could be tried before proposing a penile prosthesis implant.
Article
Introduction: The field of sexual medicine is continuously advancing, with novel outcomes reported on a regular basis. Given the rapid evolution, updated guidelines are essential to inform practicing clinicians on best practices. Aim: To summarize the current literature and provide clinical guidelines on penile traction therapy, vacuum erection devices, and penile revascularization. Methods: A consensus panel was held with leading sexual medicine experts during the 2015 International Consultation on Sexual Medicine (ICSM). Relevant literature was reviewed and graded based on Oxford criteria to develop evidence-based guideline and consensus statements. Main outcome measures: The development of clinically relevant guidelines. Results: Penile traction therapy is a viable therapy to modestly improve penile length as a primary therapy, before penile prosthesis placement in men with decreased penile length or after surgery for Peyronie's disease. It also might have a role in the acute phase of Peyronie's disease but has inconsistent outcomes in the long-term phase. Vacuum erection devices are effective in creating an erection satisfactory for intercourse, even in difficult-to-treat populations. They also might be used in the post-prostatectomy setting to maintain penile length but have insufficient evidence as a penile rehabilitation therapy. For vasculogenic erectile dysfunction, men with suspected arterial insufficiency can be evaluated with penile Duplex Doppler ultrasonography and confirmatory angiography. Penile revascularization procedures have consistently demonstrated benefits in very select patient populations; however, inadequate data exists to suggest the superiority of one technique. Men with vascular risk factors are likely poor candidates for penile revascularization, although veno-occlusive dysfunction and age are less significant. Therapies for treating primary veno-occlusive dysfunction are not recommended and should be reserved for clinical trials. Conclusions: Since the prior ICSM meeting, multiple developments have occurred in external mechanical devices and penile revascularization for the treatment of erectile and sexual dysfunction. Sexual medicine clinicians are encouraged to review and incorporate recommendations as applicable to their scope of practice.
Article
Erectile dysfunction know ledge and management have improved vastly over the last 15 years. We now see erectile dysfunction as an indicator of vascular health and a sentinel marker for cardiovascular risk stratification. As a presenting symptom, erectile dysfunction should trigger a cardiovascular assessment. Erectile dysfunction and lower urinary tract symptoms may share similar pathophysiology, and both may be managed with phosphodiesterase type 5 inhibitors. Current postprostatectomy penile rehabilitation options include these agents as well as intracavernosal injections and vacuum erection device therapy. A simplified assessment approach that relies on questions about sexual history and a physical exam can help with diagnosis and treatment of erectile dysfunction.
Article
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Generally, hypoxia is a normal physiological condition in the flaccid penis, which is interrupted by regular nocturnal erections in men with normal erectile function. [1] Lack of spontaneous and nocturnal erections after radical prostatectomy due to neuropraxia results in persistent hypoxia of cavernosal tissue, which leads to apoptosis and degeneration of cavernosal smooth muscle fibers. Therefore, overcoming hypoxia is believed to play a crucial role during neuropraxia. The use of a vacuum erectile device (VED) in penile rehabilitation is reportedly effective and may prevent loss of penile length. The corporal blood after VED use is increased and consists of both arterial and venous blood, as revealed by color Doppler sonography and blood gas analysis. A similar phenomenon was observed in negative pressure wound therapy (NPWT). However, NPWT employs a lower negative pressure than VED, and a hypoperfused zone, which increases in response to negative pressure adjacent to the wound edge, was observed. Nonetheless, questions regarding ideal subatmospheric pressure levels, modes of action, and therapeutic duration of VED remain unanswered. Moreover, it remains unclear whether a hypoperfused zone or PO 2 gradient appears in the penis during VED therapy. To optimize a clinical VED protocol in penile rehabilitation, further research on the mechanism of VED, especially real-time PO 2 measurements in different parts of the penis, should be performed.
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Objective: The vacuum erectile device (VED) uses negative pressure to increase blood inflow into the corpora cavernosum, with a ring at the base of the penis to maintain erection for intercourse or without a ring for penile rehabilitation. Owing to the limitation of phosphodiesterase 5 inhibitors (PDE5I) shown in the treatment of refractory erectile dysfunction (ED), the use of VED has resurged and is becoming the first line therapy in the treatment of ED following radical prostatectomy (RP). Currently, the combination therapy of VED with PDE5I and that of VED with intracavernous injection are advocated for post-RP ED. Hereby, we review the role of VED in penile rehabilitation, its underlying mechanisms, and the combination therapies for it.
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Radical pelvic surgery: radical prostatectomy, colonic and rectal surgery are iatrogenic causes of erectile dysfunction with major impact on health-related quality of life. The major cause of erectile dysfunction in such surgical procedures is cavernous nerve injury that leads to apoptosis of cavernous smooth muscle, fibrosis and venooclusive disease. After radical nerve-sparing prostatectomy up to 50 % of patients may develop erectile dysfunction and recover rate varies from 16%to 86 % in 6-12 month. The prevalence of erectile dysfunction after rectal surgery varies largely according to the technique used, nerve dissection, associated irradiation and chemotherapy from 33 % to 95 %. Laparoscopic and robotic-assisted surgery allows a better autonomic nerve preservation and a better postoperative sexual function. Rehabilitation programs in patients with iatrogenic erectile dysfunction must start as soon as possible in order to provide blood supply, good oxygenation and to prevent smooth muscle loss and fibrosis. Best candidates for this program are young patients with normal sexual function before surgery. First line therapy in rehabilitation programs are phosphodiesterase type 5 inhibitors, followed by intracavernosal erectogenic drugs injections and vacuum constriction devices. Rehabilitation programs are efficient in 14%-81% of patients with bilateral nerve-sparing prostatectomy and in 43%-93% of patients following robotic-assisted laparoscopic surgery.
Article
Objective To evaluate the efficacy and safety of combination therapy of sildenafil plus vacuum erection devices in men with type 2 diabetes mellitus with moderate to severe erectile dysfunction who are dissatisfied with the results of using sildenafil alone.Methods The study included 66 diabetes mellitus patients presenting erectile dysfunction for at least 6 months and dissatisfied with the use of 100 mg sildenafil monotherapy. The patients were randomized in two groups. Those in group A (n = 33) were instructed to use a vacuum erection device only, whereas those in group B (n = 33) were treated with combination therapy, including sildenafil 100 mg and a vacuum erection device. Erectile function was evaluated subjectively using the International Index of Erectile Function, Sexual Encounter Profile questionnaire questions 2 and 3 at visit 1 (baseline; study entry), visit 2 (4 weeks after baseline), and visit 3 (12 weeks after baseline; study end).ResultsThere were no significant differences in average patient age, duration of diabetes, duration of erectile dysfunction, baseline International Index of Erectile Function scores, hypertension, blood testosterone, smoking and alcohol consumption between two groups. Mean International Index of Erectile Function scores were significantly higher for group B at the 1-month (14.86 ± 2.17 vs 12.41 ± 2.63; P < 0.0001) and 3-months (17.53 ± 2.95 vs 14.29 ± 2.81; P < 0.0001) visits. Men in group B had better successful penetration (73.3% vs 46.6%) and successful intercourse (70% vs 46.6%) at 3 months compared with group A.Conclusion Combined use of sildenafil and vacuum erection device therapy significantly enhances erectile function, and it is well tolerated by diabetes mellitus patients not responding to first-line sildenafil alone.
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Context Patients with prostate cancer and their physicians need knowledge of treatment options and their potential complications, but limited data on complications are available in unselected population-based cohorts of patients.Objective To measure changes in urinary and sexual function in men who have undergone radical prostatectomy for clinically localized prostate cancer.Design The Prostate Cancer Outcomes Study, a population-based longitudinal cohort study with up to 24 months of follow-up.Setting Population-based cancer registries in 6 geographic regions of the United States.Participants A total of 1291 black, white, and Hispanic men aged 39 to 79 years who were diagnosed as having primary prostate cancer between October 1, 1994, and October 31, 1995, and who underwent radical prostatectomy within 6 months of diagnosis for clinically localized disease.Main Outcome Measures Distribution of and change in urinary and sexual function measures reported by patients at baseline and 6, 12, and 24 months after diagnosis.Results At 18 or more months following radical prostatectomy, 8.4% of men were incontinent and 59.9% were impotent. Among men who were potent before surgery, the proportion of men reporting impotence at 18 or more months after surgery varied according to whether the procedure was nerve sparing (65.6% of non–nerve-sparing, 58.6% of unilateral, and 56.0% of bilateral nerve–sparing). At 18 or more months after surgery, 41.9% reported that their sexual performance was a moderate-to-large problem. Both sexual and urinary function varied by age (39.0% of men aged <60 years vs 15.3%-21.7% of older men were potent at ≥18 months [P<.001]; 13.8% of men aged 75-79 years vs 0.7%-3.6% of younger men experienced the highest level of incontinence at ≥18 months [P = .03]), and sexual function also varied by race (38.4% of black men reported firm erections at ≥18 months vs 25.9% of Hispanic and 21.3% of white men; P = .001).Conclusions Our study suggests that radical prostatectomy is associated with significant erectile dysfunction and some decline in urinary function. These results may be particularly helpful to community-based physicians and their patients with prostate cancer who face difficult treatment decisions. Prostate cancer is the most frequently diagnosed solid tumor in US men. An estimated 179,300 men will be diagnosed as having the disease in 1999,1 and in more than 70% of these patients, the disease will be clinically localized.2 Treatment options for men with tumors confined to the prostate who have at least a 10-year life expectancy include radical prostatectomy, external beam radiation, brachytherapy, or expectant management. Each of these approaches is associated with a different spectrum of morbidity and effects on quality of life, which may be short-term or long-term. To make informed choices about treatment alternatives, patients with prostate cancer and their physicians need accurate information to assess the potential and pattern of complications associated with each option. Numerous investigators have assessed urinary and sexual function 1 or more years after radical prostatectomy, with rates of incontinence ranging from 4% to 40% and impotence from 29% to 75%.3- 12 These findings reflect the experiences of patients from selected clinical practices,3- 5,7- 9,12 a health maintenance organization,10 and Medicare recipients.6,11 Differences in patient mix, study size, and data collection methods may explain the wide range of results. Limited data are available to describe the outcome experiences of unselected population-based patients. We report results from the multicenter Prostate Cancer Outcomes Study (PCOS), which has completed longitudinal assessments of functional status in a large community-based cohort of patients with prostate cancer treated with radical prostatectomy for clinically localized disease.
Article
The U.S. Food and Drug Administration (FDA) lists vacuumconstriction devices (VCD) as safe, nonsurgical therapy for erectile dysfunction. Our study compared the responses of 30 male (10 novice and 20 regular) VCD users of seven commercially available systems (Mentor Response, Mentor-Touch, Mentor-Piston, Dacomed Catalyst, Mission VED, Osbon ErecAid, and Pos-T-Vac). Variables evaluated included simplicity of instruction, ease of use, cost, instructional value of videotape, company follow-up, presence of a pressure-limitation gauge, and length of warranty. The results from our study show (1) 100 percent reported an additional cost to be of minor importance in determining choice of device, (2) 80 percent of novice and 95 percent of regular users stated the instructional videotape was essential, (3) 95 percent of the participants desired a twenty-four-hour hot-line, (4) 40 percent of novice users but only 25 percent of regular users wanted personalized company follow-up, (5) 100 percent of novice users preferred single-handed devices, while regulars showed no preference. (6) Regular users scored Mentor Response, Osbon ErecAid, and Mentor-Piston highest regarding ease of use. While the vacuum constriction devices are conceptually similar, there are subtle operational distinctions between the different brands. The clinical urologist should be aware of these nuances.
Article
Prostate cancer remains the most common cancer in adult men. Its treatment usually results in compromised or absent erectile function. This article will review the treatment options available to resume sexual activity following prostate cancer therapy and will focus on non-surgical treatment options. In addition, intracavernosal injection therapy has been shown to enhance recovery of spontaneous, unassisted erections when started shortly after nerve-sparing radical prostatectomy. Most recently, oral treatment with sildenafil citrate begun shortly after surgery was shown in a placebo-controlled trial to encourage return of normal erections. Presumably this occurs by promoting nocturnal erections which appear to prevent the permanent neurovascular damage to the penis following radical prostate surgery.
Article
Twelve patients with erectile impotence related to diabetic neuropathy were treated with a vacuum device, Pos-T-Vac. Efficacy of the device and psychological evaluation (Dyadic Adjustment Scale for marital satisfaction and Hamilton Rating Scale for depression) were performed before and 3 months after treatment. Vacuum therapy was successful in 75% of the patients. Patients with successful impotence treatment and normal baseline marital satisfaction scores showed a modest increase in the scores of marital satisfaction (from 114 +/- 3 points, baseline, to 121 +/- 3 points, posttreatment; p <0.05). Vacuum therapy for the treatment of erectile dysfunction due to diabetic autonomic neuropathy appears to be safe and effective. (C) Copyright 1992 Southern Society for Clinical Investigation
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Introduction. The Journal of Sexual Medicine (JSM) held a debate at the annual fall meeting of the Sexual Medicine Society of North America (SMSNA). The motion was “Penile Rehabilitation Should Become the Norm for Radical Prostatectomy Patients.” At the suggestion of several SMSNA members, it was requested that this debate might be of interest to JSM readers in the form of a published controversy. Methods. Two debate speakers with expertise and/or strong opinions in the area of penile rehabilitation submitted their literature-review, evidence-based opinions on the topic. Main Outcome Measure. Literature review of laboratory basic science and clinical research studies on penile rehabilitation. Results. Penile rehabilitation involves prophylactic procedures designed to improve oxygen delivery to penile erectile tissues, aimed at preserving erectile tissue health and minimizing erectile tissue damage that otherwise occurs during the period of neural recovery to the autonomic cavernosal nerve following radical prostatectomy. There are several studies in the sexual medicine literature on penile rehabilitation after radical prostatectomy, and the positive results appear to support this concept, the rationale, and mechanism. The use of prophylactic penile rehabilitation programs has not been fully elucidated, nor have the results been replicated in large multicenter placebo-controlled trials. Conclusion. Penile rehabilitation may be performed along with counseling with the couple, vacuum erection therapy, and vacuum erection device therapy if it is the patient and partner's preference, provided that it is undertaken in a safe and effective manner and is monitored closely. Mulhall JP, and Morgentaler A. Penile rehabilitation should become the norm for radical prostatectomy patients. J Sex Med 2007;4:538–543.
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In 1996, the American Urological Association began to recommend the vacuum constriction device (VCD) as an alternative to the treatment of erectile dysfunction (ED) (Montague et al. Journal of Urology 156, 2007–2111, 1996). Since then, millions of Americans have benefitted from the device. It remains well-accepted and popular among patients due to its efficacy, noninvasiveness, ease of administration, and affordability. Nearly all patients, including those with hematological disorders, experience some degree of erection with the device. The process of applying negative pressure to passively fill the corpus cavernosum via arterial and venous sources remains the basis of mechanism since its conception in 1874. With the advent of oral pharmacotherapy for the treatment of ED, its usage and availability have decreased tremendously. However, its application is being expanded into new realms. Penile rehabilitation following prostatectomy is a perfect example. Despite increasing success of surgical and medical therapy for ED, the demand for a noninvasive, effective, safe, drug-free, and cost-effective treatment persists. This chapter presents the development of VCD, its mechanism of action, indications, safety profile, efficacy, and future directions. KeywordsProstatectomy-Penile rehabilitation-Corpora cavernosa-Tumescence-Penile length preservation
Article
PurposeThe American Urological Association convened the Clinical Guidelines Panel on Erectile Dysfunction to analyze the literature regarding available methods for treating organic erectile dysfunction and to make practice recommendations based on the treatment outcomes data.Materials and MethodsThe panel searched the MEDLINE data base for all articles from 1979 through 1994 on treatment of organic erectile dysfunction and meta-analyzed outcomes data for oral drug therapy (yohimbine), vacuum constriction devices, vasoactive drug injection therapy, penile prosthesis implantation and venous and arterial surgery.ResultsEstimated probabilities of desirable outcomes are relatively high for vacuum constriction devices, vasoactive drug injection therapy and penile prosthesis therapy. However, patients must be aware of potential complications. The outcomes data for yohimbine clearly indicate a therapy with marginal efficacy. For venous and arterial surgery, based on reported outcomes, chances of success do not appear high enough to justify routine use of such surgery.ConclusionsFor the standard patient, defined as a man with acquired organic erectile dysfunction and no evidence of hypogonadism or hyperprolactinemia, the panel recommends 3 treatment alternatives: vacuum constriction devices, vasoactive drug injection therapy and penile prosthesis implantation. Based on the data to date, yohimbine does not appear to be effective for organic erectile dysfunction and, thus, it should not be recommended as treatment for the standard patient. Venous surgery and arterial surgery in men with arteriolosclerotic disease are considered investigational and should be performed only in a research setting with long-term followup available.