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- Clinical Experience -
Combination therapy for male erectile dysfunction and urinary
incontinence
Helen Zafirakis1, Run Wang1, 2, O. Lenaine Westney1, 2
1Division of Urology, University of Texas Health Science Center at Houston, Houston, TX 77030, USA
2Department of Urology, MD Anderson Cancer Center,
Houston, TX 77030, USA
Abstract
Urinary incontinence (UI) and erectile dysfunction (ED) are both very prevalent conditions. Insertion of an
artificial urinary sphincter (AUS) and penile prosthesis (PP) is an effective and proven method of treatment for both
conditions. With advancing age, as well as with increasing populations of patients radically treated for prostate
cancer, the occurrence of both conditions found in the same patient is increasing. The purpose of this article was to
analyze the available evidence for simultaneous surgical management of male ED and UI using prosthetic devices.
The existing literature pertaining to dual implantation of AUS and PP was reviewed. The concomitant insertion of the
PP with the male perineal sling was also considered.
Concurrent ED and UI are increasingly seen in the post radical
prostatectomy population, who are often younger and less willing to suffer with these conditions. Insertion of an AUS
and PP, either simultaneously or as a two-stage procedure, appears to be a safe, efficacious and long-lasting method
of treatment. The improvements in design of both the AUS and PP as well as the development of the single transverse
scrotal incision have made simultaneous insertion of these prostheses possible. Dual implantation of the PP and male
sling looks promising in a selected population. In conclusion,
the insertion of the AUS and PP for the treatment of
concurrent UI and ED is safe and effective. Simultaneous insertion of these prostheses in the same patient offers
potential advantages in operative and recovery time and is associated with high patient satisfaction. Combination
therapy should therefore be included in the arsenal of treatment of these
conditions. (Asian J Androl 2008 Jan; 10: 149_154)
Keywords: urinary incontinence; erectile dysfunction; impotence; penile prosthesis; artificial urinary sphincter; male sling
Correspondence to: Dr O. Lenaine Westney, Division of Urology, The University of Texas Health Science Center at Houston, MSB Suite
6.018, 6431 Fannin Street, Houston, TX 77030, USA.
Tel: +1-713-500-7328 Fax: +1-713-500-7319
E-mail: Ouida.L.Westney@uth.tmc.edu
DOI: 10.1111/j.1745-7262.2008.00364.x
1 Introduction
Urinary incontinence (UI) due to urethral sphincter dysfunction affects up to 40% of men who have undergone
radical prostatectomy [1]. The artificial urinary sphincter (AUS) is recognized as the gold standard for the treatment
of urethral sphincter dysfunction and is also indicated in patients following urethral trauma where other
anti-incontinence measures have failed. Erectile dysfunction (ED) affects an enormous number of men, most of whom have an
organic cause for their ED. When conservative measures have failed to successfully treat ED, the insertion of a penile
prosthesis (PP) is a well established option with excellent long-term results and a consistently high patient satisfaction
rate.
In a significant number of men, ED and UI co-exist, understandably contributing to a significant decline in quality
of life. In addition, the numbers of men undergoing radical treatment for relatively early stage prostate cancer is
increasing, leading to a growing population of men with concurrent organic ED and urethral sphincter incompetence.
Although most of these patients can be adequately treated with conservative treatment modalities, approximately 2%
will elect to have a PP inserted [2] and a higher proportion to have an AUS inserted. Synchronous or non-synchronous
insertion of an AUS and PP is an appropriate treatment option in these patients, with good long-term results.
2 Historical perspective
The modern versions of both the AUS and the PP were popularized by Scott in the 1970s [3, 4]. Since
then, there have been progressive improvements in the
design of both implants. In 1983, the AMS 800 was
introduced. This version of the device consisted of a
narrow-backed cuff coated with a special lubricant, which
allowed for a more even distribution of pressure around
the cuff and a reduction in kink and stress fatigue, which
can cause leakage. It also resulted in a significant
reduction of urethral atrophy [5]. Other developments included
the introduction of a poppet valve in the pump which
facilitates deactivation of the device and kink-resistant
tubing with improved connectors. These developments,
together with delayed activation of the device after insertion,
have dramatically reduced the risks of complications [5].
The penile prosthesis can be inflatable, with two or
three-piece types, or semi-rigid, which include the malleable
and mechanical types. They are indicated in a variety of
conditions which cause ED, such as Peyronie's disease,
corporal fibrosis following priapism, ED following radical
treatment for prostate cancer, spinal cord injury and in those
patients requiring penile reconstruction following penile girth
or length loss. Refinements of the PP such as Teflon sleeves
on the cylinders have greatly improved the longevity and
satisfaction associated with this device.
Synchronous insertion of the AUS and PP has not
become popular despite obvious advantages. The reasons
for concern are problems with mechanical failure
associated with each device and the risk of infection, which
would potentially necessitate the removal of all components.
In addition, there were concerns over the extent of
dissection required to insert and place the components,
further increasing the risks of erosion and infection.
A two-stage procedure implies that extra care is
needed to avoid damaging the components of the
existing implant and the added danger of operating in an area
with surgical scarring. With the development of the single
transverse scrotal incision to insert an AUS [6], the
synchronous insertion of an AUS and PP became possible.
The advantages of this approach are a single incision and
anaesthetic, faster operating time, shorter hospital stay
and possibly the supine position, which allows more
mobility of the bulbar urethra. The pump of the AUS is
also easier to place and may reduce the risk of pump
migration [6].
3 Assessment of patients
A detailed history and examination of the patient
assists in identifying the etiology of the ED and urinary
incontinence. Video urodynamics are required to verify
sphincter incompetence, supplemented by cystoscopic
examination of the urethra and bladder neck regions, a
voiding diary and a pad test. In most cases of organic
ED, the cause is obvious in this population, such as a
history of radical prostatectomy for prostate cancer.
However, if there is some doubt as to the diagnosis of
ED, a full ED work-up should be performed, including
nocturnal penile tumescence studies and Doppler studies
were appropriate.
The patient should possess the intellectual capacity
and manual dexterity which would allow them to use the
devices correctly. Any detrusor overactivity, especially
in the context of a small capacity bladder should be
treated prior to implantation of an AUS.
4 Surgical technique
Careful preoperative preparation of the patient is
critical to reducing the incidence of infection. It is important
to exclude any urinary tract infection prior to insertion
of the penile and artificial sphincter prostheses.
Additionally, care should be taken that there is no
irritation in the perineal or genital skin. If a Foley catheter has
been in place, this should be removed a week or so prior
to surgery to eradicate bacterial colonization urine. Some
surgeons recommend that the patient use a
chlorhexidine-based wash 24 hours before surgery to reduce the
overall bacterial load on the skin. Following induction of
anaesthesia, the patient is placed in the supine position
with the legs slightly abducted. He should be shaved in
the operating room, just prior to surgery, to minimize
abrasion and trauma to the perineal skin which can also
increase the risk of infection. A 5- to 10-minute scrub of
the perineal and suprapubic skin with chlorohexidine
soap, followed by application of alcohol-based
disinfectant reduces intraoperative colonization.
Although the use of antibiotics associated with the
AUS and PP vary widely, the use of preoperative
antibiotics is universal. Antibiotics should be broad-spectrum
and cover both aerobic and anaerobic organisms and
should be given parenterally. They should be continued
in this fashion for 24 hours, after which they may be
given orally, usually for further four or five days.
A soft latex 12_14 Fr Foley catheter is placed in the
urethra. To insert both the PP and the AUS, a single
transverse scrotal incision is made a few centimeters
below the penoscrotal junction [7] (Figure 1A and 1B).
This incision allows adequate exposure to both the
bulbar urethra and the corpora. The corpora are then
exposed and the scrotal septum is divided. The
bulbocavernosus is dissected to expose the entire bulbous urethra
and the remainder of the bulb is dissected free from the
corpora by dissecting through the Buck's fascia.
Wilson [6] reports that by using the single upper transverse
scrotal incision, the bulbocavernosus muscle does not
need to be disturbed in order to place the AUS cuff at the
bulb. However, to access the proximal bulb, the muscle
must be retracted ventrally while continuing to divide the
midline attachment to the raphe. This dissection should
be continued until the perineal body has been
encountered and divided sharply. Circumferential dissection of
the urethra is then performed for a sufficient vertical
distance to accommodate the 2.0 cuff width.
The correct AUS cuff size is then determined using the
measuring device and the cuff placed. In most cases, the
remaining elements of the AUS are placed prior to starting
the PP part of the surgery.
Vertical corporotomies are then made bilaterally
(Figure 2). The corpora are dilated and sized for the
cylinders (Figure 3). Once the cylinders are in place, the
corporotomies are sutured such that they are water-tight.
The bladder is then emptied by suction and the catheter
plug or clamp replaced. Gloves and suction tip are
changed. The reservoirs are then placed on either side in
the prevesical space by puncturing the transversalis
fascia [7] and the tubing, pump and connections are
completed. The pumps are placed in the scrotum on
either side, without opening the tunica vaginalis (Figure
4A and 4B). The AUS is cycled and left in a deactivated
state and the PP is left inflated overnight as usual to
minimize bleeding. A Foley catheter is left in place for 24
hours. A suction drain may be placed at the lowest point
of scrotal dissection, coming out at the level of the pubic
tubercle (Figure 5A and 5B). Layers are closed by
continuous suture, with care not to damage any prosthetic
material. Usually three layers can be closed before skin
closure and dressing is applied.
Some surgeons use a second low transverse
suprapubic incision to place the reservoir of the PP [8]. However,
access can usually be accomplished via the scrotal
approach and thus both implants can be successfully placed
with a single scrotal incision. Important maneuvers to
help avoid infection post operatively include meticulous
care and avoidance of hematoma formation. Some
surgeons will also apply ice packs to the perineal area to
reduce edema and assist with pain control [8].
If the implants are not to be placed synchronously,
the AUS is usually placed first followed by the PP. Great
care needs to be taken to avoid interrupting the AUS cuff
when subsequently placing the PP components, especially the cylinders. A malleable prosthesis can also be
inserted via the penoscrotal transverse incision and
dissection of the corpora more distally can avoid
encountering the AUS prosthesis. An added advantage of using
a malleable prosthesis is the smaller number of
components needed, especially if the scrotum is small.
Patients can usually be discharged within 24 of
surgery on oral antibiotics. The inflatable PP can be
activated in as early as 2 weeks, if intracorporal fibrosis was
marked; otherwise cycling can begin at 6 weeks when
the AUS can also be activated.
The male perineal sling is a procedure which is more
recently gaining popularity for the treatment of male UI.
It uses a silicone coated polymer mesh material and is
anchored in place by 6 bone screws which are fixed to
the descending pelvic pubic rami, resulting in
compression of the distal bulbar urethra by increasing urethral
coaptation at this point. The operation has previously
been described in the literature and essentially consists
of a mid-perineal incision and exposure of the
bulbospongiosis muscle, The material is anchored to the
inferior public rami utilizing titanium bone screws.
Broad-spectrum antibiotics are given and the patient
is placed in an exaggerated lithotomy position. Under
general or spinal anesthesia, a 16-Fr Foley catheter is
placed. A midline perineal incision is then performed with
dissection down to the bulbospongiosus and inferior
pubic rami (Figure 6). Six titanium screws_three on each
side_with swedged on #1 polypropylene sutures are then
drilled in the pelvic bone, carefully avoiding the corpora
as there is a risk of bleeding. The perineal incision may
be shifted superiorly or a separate penoscrotal incision is
made to facilitate the insertion of the PP. The cylinders
of the inflatable PP are inserted next via corporotomies
as usual. The remaining components of the PP are placed
but left deflated so that the mesh of the sling can be
positioned more easily and to prevent damage to the
components of the PP (Figure 7A and 7B). The
polypropylene mesh is then tied down on either side using the
sutures already attached to the screws and the tension is
adjusted. A retrograde leak point pressure test may be
performed at this point. The sutures are then tied. There
should be some resistance to passing the 16 Fr Foley
after the sling is placed. In a small series of patients who
underwent this procedure, there were no perioperative
complications and all were home within 24
hours. All patients were completely dry and satisfied at one year
[9]. Alternatively, the sling may be placed in its entirety
followed by the PP. However, due to the placement of
the apical screws close to the pubis, it may then be
difficult to insert the PP [9].
5 Complications
Although there is much written about the outcomes
of AUS and PP insertion alone, there is a relative paucity
of quality data involving the outcome of synchronous
insertion of AUS and PP. Most studies mention the
combined procedure anecdotally within series looking at
either device alone. These represent very small numbers,
about which it is difficult to comment. However, two
papers have looked at this topic in some detail.
Bhalchandra et al. [8] looked at combined
implantation of PP and AUS in 65 patients, 40 of whom had the
implants performed simultaneously. The remaining
patients had their PP inserted either before or after the AUS.
In this study, a dual-incision approach was used as
described above and the patients were grouped according
to which AUS device was used, where group 1 were inserted with older AUS devices and group 2 were
inserted with the AMS 800 sphincter. Over a mean of 35
months of follow-up, 90% of patients required one pad
or less for continence and 98% of the PP were functional.
34% of patients in group 1 and 40% of patients in group
2 required revisions. Although this study did not
distinguish those patients who had synchronous insertion of
AUS and PP, two patients had the AUS components removed for infection, two had the PP removed for
infection and further three had both sets of components
removed for erosion of the cuff or cylinders, giving an
overall erosion/infection rate of 11%. None of the
inflatable PP required revision [8].
Kendirci et al. [10] looked at synchronous insertion of
an AUS and inflatable PP via a single upper transverse
scrotal incision in 22 men. In their series, at 17 months, 9% of
patients had an erosion, with no infections noted
[10]. No patient required more than one pad per day for continence.
There is little published data looking at the infection
and erosion rate of combined implants. Two studies
looking at this have reported an AUS infection/erosion rate of
between 16% and 25% [10, 11]. In one study looking at
447 men with PP, the infection/erosion rate was 13% at
50 months follow-up [12].
The incidence of mechanical failure with the AUS
device is 32% over the long term [11] but has been
reported to be as low as 7.6% in one series which looked
at the device after the introduction of the narrow-backed
cuff [5]. In Minervini's series, the mechanical failure rate
was 21% [13]. Bhalchandra's series showed a
mechanical and technical failure rate of 48% overall with a
proportionally higher rate of failure in the group where the older
AUS device was used (62% vs. 25%) [8]. Kendirci's
series reported reservoir migration in two (9%) patients [10].
Further reports on simultaneous insertion of AUS and
PP are limited. In one study looking at the management
of UI following prostatectomies of various sorts, four
out of 37 patients had a synchronous insertion of an AUS
and PP with no complications after a mean of 37 months
follow-up [14]. Wilson reported on using an upper
transverse scrotal incision to insert an AUS, with 11 out of the
37 patients also having an inflatable PP inserted through
the same incision [6]. Most of these were placed in
patients requiring revision AUS surgery. The incidence
of infection was 9% and no patient had mechanical
failure or atrophy at one year.
6 Outcomes of combination surgery
Combination therapy with the AUS and PP has been
shown to be feasible, safe and an efficacious method for
the surgical treatment of ED and UI. The patient
satisfaction for either implant alone or in combination has
been consistently and reproducibly high. The benefits
are also obvious if one looks at cost and time savings
with synchronous insertion. One study looking at this
demonstrated reduced operation time using the
synchronous approach as well as a cost savings of USD 7 000,
compared with staged procedures [15].
Literature on irradiation and results of combination
therapy with AUS and PP is scarce. In one series, the
only erosions following synchronous insertion of an AUS
and PP occurred in the irradiated patients post radical
prostatectomy [10]. Previous irradiation in patients
receiving an AUS has demonstrated higher revision rates in
some studies [16] mostly due to urethral atrophy.
Evidence on the risk of erosion and infection in the
irradiated population with an AUS is inconsistent [16_19]. This
issue is also confounded by the fact that erosion in the
irradiated population may be due to the poorer quality of
the irradiated tissue or to improper sizing of the urethral
cuff or even by an unrecognized injury to the urethra
during dissection.
Evidence on the use of PP in the context of the
irradiated patient is relatively lacking. One paper studied the
insertion of PP following radiotherapy for prostate cancer
in 43 men [20]. At a mean follow-up of 40 months, 70%
of patients were using their implant for sex. There were
no incidences of infection or erosion, with only a 7%
malfunction rate and a high satisfaction rate.
The results of the male perineal sling vary in the
literature, however, intermediate follow-up demonstrates
that 80%_93% are dry or socially dry (one pad or less
per day) at 3_4 years follow-up [21, 22]. The male sling
may be more suited to patients with no more than
moderate UI and there is concern over the durability of this
technique. Stringent patient selection will therefore
continue to be important as this procedure is developed and
its outcomes are assessed. In the only study looking at
dual implantation of the sling and the PP [23] no patients
were reported to have any peri-operative complications
and the implication from this study is that at 1 year, no
patients reported further complications and all four were
dry and satisfied with the operation. It is still prudent,
however, to apply the same patient selection criteria to
this group as to those who are considered for the male
sling only; that is, those with mild to moderate UI and
who are also good candidates for a PP.
7 Technical considerations of simultaneous
insertion of AUS and PP
Although simultaneous insertion of an AUS and PP is
appealing there are some drawbacks. Most authors
report that it is easier to do the AUS portion of the insertion
first, then start placing the penile components [8, 10].
Once the AUS cuff is in place, great care needs to be
taken to avoid damaging the cuff and urethra while
placing the PP cylinders. The respective tubing needs to be
positioned such that tubing from one prosthesis does not
interfere with that of the other.
In the event of an infection, the concern is that it will
spread to all components necessitating their removal and
making revision more challenging. Bhalchandra argues
that in this situation, if one acts early to locate the
components effected, it is possible to salvage the
components of the unaffected device [8]. Erosion without
infection may make salvaging one of the devices possible
however in the context of infection, it can sometimes be
very difficult to determine which components are affected. One would expect similar considerations in
patients who have had a PP inserted in conjunction with
a male sling, however, there is currently no published
data looking at this.
8 Conclusion
Both the AUS and the PP are established treatments
for urethral sphincter dysfunction and ED, respectively.
With the high prevalence of both conditions and the
increasing awareness of the treatments for these conditions,
it is anticipated that more men will present to their
physicians for a resolution to these debilitating problems.
Additionally, concurrent ED and incontinence are
increasingly seen in the post radical prostatectomy population,
who are often younger and less willing to suffer with
these conditions. Insertion of an AUS and PP, either
simultaneously or as a two-stage procedure is a safe,
efficacious and long-lasting solution to these problems.
The technical design improvements of both the AUS and
PP as well as the availability of the single transverse scrotal
incision have made simultaneous insertion of these
prostheses possible, with shorter net operating times,
hospital stay and recovery time. Insertion of the PP in
conjunction with the male perineal sling is still a relatively
new approach to combination therapy and may find
success in selected patients with mild to moderate stress UI
who are also good candidates for PP. Patient
satisfaction is consistently high and will continue to drive this
combined approach.
Acknowledgment
Thanks to Paul K. Hegarty for the use of his pictures
on penile prosthesis (PP).
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