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Review – Incontinence
Article history: Context: Radical prostatectomy is the most common reason for male stress urinary
Accepted January 3, 2016 incontinence. There is still uncertainty about its diagnostic and therapeutic manage-
ment.
Associate Editor: Objective: To evaluate current evidence regarding the diagnosis and therapy of post-
James Catto prostatectomy incontinence (PPI).
Evidence acquisition: A systematic review of the literature was performed in October
2015 using the Medline database.
Keywords: Evidence synthesis: Diagnosis and conservative treatment of PPI are currently mostly
Male urinary stress incontinence based on expert opinions. Pelvic floor muscle training is the noninvasive treatment of
choice of PPI. For invasive management of moderate to severe PPI, the artificial urinary
Postprostatectomy incontinence
sphincter is still the treatment of choice, but an increasing number of adjustable and
Conservative treatment nonadjustable, noncompressive as well as compressive devices are used more frequent-
Surgical treatment ly. However, no randomized controlled trial has yet investigated the outcome of one
Pelvic floor muscle training specific surgical treatment or compared the outcome of different surgical treatment
Artificial urinary sphincter options.
Conclusions: The level of evidence addressing the surgical management of PPI is still
Male slings unsatisfactory. Further research is urgently needed.
Efficacy Patient summary: Incontinence after the removal of the prostate (postprostatectomy
Safety incontinence) is the most common cause of male stress urinary incontinence. First-line
therapy is physiotherapy and lifestyle changes. If no satisfactory improvement is
obtained, various surgical treatment options are available. The most commonly used
is the artificial urinary sphincter, but other treatment options like male slings are also
available.
# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.
http://dx.doi.org/10.1016/j.euf.2016.01.002
2405-4569/# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
EUF-100; No. of Pages 15
still high and vary between 6% and up to 69% [4]. This reference lists were also screened for relevant articles.
variation is mostly due to a missing standardization of Initially, articles were screened and selected based on their
definition either of PPI itself or of the severity of the abstracts and then studied in detail. All original articles
respective incontinence [5], and also because of significant addressing the diagnosis and conservative as well as
differences in data acquisition [6]. However, there is surgical management of PPI were included. In total,
evidence for certain risk factors that accompany an >1200 articles were screened and consequently >100 were
increased risk of PPI. These risk factors include patient- systematically reviewed for evidence (Fig. 1).
derived factors such as age and body mass index as well as
technical features and experience of the surgeon [4,7– 3. Evidence synthesis
9]. Confronted with an increasing number of patients with
PPI, urologists can currently choose from a variety of 3.1. Diagnosis
different conservative as well as invasive treatment options.
We provide current evidence regarding the diagnosis To guarantee a sophisticated therapeutic approach, mean-
and management of PPI and offer expert opinions regarding ingful diagnosis is crucial. However, evidence regarding the
the surgical management of PPI. diagnosis is currently based on expert opinions. The current
European Association of Urology (EAU) guidelines support a
2. Evidence acquisition two-step assessment of patients seeking help for urinary
incontinence [10]. The first step includes a medical history,
In October 2015, we conducted a literature search in the physical examination, and an objective assessment of
PubMed/Medline database using the keywords post-pros- symptoms. The medical history can be particularly helpful
tatectomy incontinence (Medical Subject Headings [MeSH]) in specifying the diagnosis of PPI. The ability to disrupt the
OR postprostatectomy incontinence [MeSH], and an addi- urine flow, the severity of incontinence over the day (eg, is
tional PubMed/Medline database search was conducted there worsening in the afternoon/evening?), the presence or
using the keywords urinary incontinence [MeSH] AND male absence of nighttime incontinence, and the existence of
[MeSH] AND artificial urinary sphincter male sling/male incontinence-triggering situations (eg, coughing, moving to
adjustable sling/Argus/ArgusT/ATOMS/Pro-ACT/AdVance/ an upright position, running, sports, in a horizontal position,
AdVanceXP/Remeex/ pelvic floor muscle training/duloxetine fatigue) [11].
[MeSH], respectively. Our search was restricted to articles These expert recommendations highlighting the value of
published in English in the last 20 yr. The respective a sophisticated medical history are based on current
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
EUF-100; No. of Pages 15
findings regarding the pathophysiology of male SUI. It has function including the functional sphincter length (‘‘coap-
been shown that the external sphincter complex consists of tive zone’’) and determine suitability for a potential
slow and fast twitch fibers that allow a tonic contraction for retrourethral transobturator male sling implantation
baseline continence, on the one hand, and rapid recruitment [21]. If the patient has any indication of concomitant
following rapid pressure increase and/or voluntary disrup- overactive bladder (OAB) symptoms or neurogenic dis-
tion of the urine flow, on the other. Baseline continence is orders, a multichannel urodynamic testing is mandatory.
additionally sustained by a combination of smooth muscle Regarding the urodynamic evaluation of the residual
fibers and the slow-twitch striated muscle fibers internal sphincter function, the use of abdominal leak point
[12,13]. PPI is usually caused by an impaired function of pressure via transrectal catheterization seems to be more
smooth muscle fibers and therefore is primarily a problem accurate than the measurement of the Valsalva leak point
of reduced baseline continence. This is why men with so- pressure (VLPP) [22]. Debate is still ongoing regarding the
called model PPI usually report incontinence episodes after use of urodynamics in general and the VLPP in particular in
exhausting the striated muscle fiber complex (eg, during terms of therapeutic decision making. Barnard et al.
longer physical activity like sports or longer walks with analyzed the preoperative urodynamic findings of
worsening over the day and no urine loss during coughing 46 patients undergoing AdVance male sling implantation
[14]). and found a VLPP >100 cm H2O having a high predictability
According to the EAU guidelines, basic diagnostics for postoperative success (defined as no pads or one safety
should also include a urinalysis and an ultrasound of the pad) [23]. In contrast, Han et al. found no negative impact of
bladder including measurement of postvoid residual urine an impaired preoperative VLPP on functional outcome after
(grade of recommendation [GR]: A) [10]. To assess male sling implantation [24]. Trigo Rocha et al. analyzed
concomitant voiding and storage disorders, voiding diaries preoperative urodynamic findings of 40 consecutive
should be used (GR: A) [10]. According to current EAU patients undergoing artificial urinary sphincter (AUS)
guidelines, standardized questionnaires do not have to be implantation due to intrinsic sphincter deficiency and
used regularly but offer useful additional information in found no correlation between preoperative urodynamic
standardized clinical settings such as clinical trials (GR: B) findings and the surgical outcome [25].
[10]. Thus currently no evidence shows that the preoperative
Various validated testing tools are available; the most VLPP might play a similar important role in predicting
frequently used ones include the International Consultation postoperative success as it does in female patient cohorts
on Incontinence-Short Form [15], the Patient’s Global [26]. Cornu et al. concluded in a recent review article that
Impression of Improvement Score [16], and the UCLA/ urodynamic studies might not be relevant in all PPI patients
RAND-Prostate Cancer Index Urinary Function Score [27].
[17]. Strong evidence indicates that the number of pads In summary, a correct diagnosis should be performed to
per day correlates well with the weight that can be objectify the patient’s symptoms, to reveal any contra-
measured during a standardized pad test [18]. This indications regarding potential surgical treatment options,
indicates that grading of a patient’s incontinence based and to detect and objectify any concomitant comorbidities
on daily pad usage is sufficient for a daily routine. In clinical and complicating factors. Based on the findings during
trials, standardized pad tests are useful to objectify the diagnosis, one should be able to classify among mild,
patient’s urine loss [19]. However, there is still insufficient moderate, and severe sphincter impairment and plan
evidence about the optimal length of standardized pad further treatment accordingly [10].
testing. Evidence indicates that a 24-h pad test is the most
accurate one [20]. However, a 1-h pad test seems more 3.2. Conservative therapy
feasible in daily practice and is therefore the most widely
used. Besides lifestyle interventions, conservative therapy for PPI
Since 2003, the International Continence Society has includes physiotherapy (pelvic floor muscle training
provided a classification of SUI based on the 1-h pad test: [PFMT]) as well as pharmacotherapy. Lifestyle interventions
grade 1, urine loss <10 g; grade 2, urine loss 11–50 g; grade include timed voiding, reduction of fluid intake, and the
3, urine loss 51–100 g; grade 4, urine loss >100 g [19]. It has reduction of bladder irritants (caffeine, hot spices). The
to be kept in mind, however, that usually a retrograde value of behavioral therapy was highlighted by Goode et al.
bladder filling is needed to perform a proper 1-h pad test. [10,28]. Recommendations for lifestyle interventions are
Current guidelines indicate that an initial conservative still mainly based on expert opinions [10].
treatment attempt should be performed after basic
diagnostics [10]. If this attempt fails and a surgical approach 3.2.1. Physiotherapy
is initialized, a more invasive diagnosis should be Following current EAU guidelines, instruction for PFMT
performed [10]. Urethrocystoscopy aims to detect potential should be offered to all men undergoing RP to speed up
urethral pathologies such as bladder neck stenosis or postoperative continence recovery (GR: B) [10]. Fernández
urethral stricture that might contribute to current symp- et al. recently performed a meta-analysis of eight random-
toms or complicate a future surgical approach. Urethro- ized controlled trials [29]. Four of the analyzed studies
scopy can also be used to perform a so-called repositioning compared PFMT with no physiotherapy [28,30–32]; the
test and thereby evaluate the patient’s residual sphincter remaining four studies compared PFMT sessions under
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
EUF-100; No. of Pages 15
professional supervision with PFMT at home [33–36]. The fatigue (50% vs 13% placebo), insomnia (25% vs 20%), loss of
authors found that PFMT improves continence rate in the libido (19% vs 7%), constipation (13% vs 7%), nausea (13% vs
short, medium, and long-term follow-up after RP and 7%), diarrhea (13% vs 7%), and dry mouth (6% vs 0%)
concluded that programs should include at least three sets [44]. There is also current evidence that duloxetine seems to
of at least 10 repetitions of muscle training daily [29]. How- have synergistic effects when combined with PFMT [43]. It
ever, it has to be stated that nearly all studies in this meta- must be kept in mind that treatment of male SUI with
analysis focused on the perioperative period. Furthermore, duloxetine is still off label [46]. Current EAU guidelines
it does not include the recent controlled randomized clinical conclude that duloxetine should not be offered to men who
trial by Geraerts et al, who analyzed 180 patients undergoing are seeking a cure of their SUI but for a temporary symptom
RP and randomized them into a group that started PFMT 3 wk relief (GR: B) [10].
before RP (altogether three preoperative sessions) and a
control group that started PFMT postoperatively. The authors 3.3. Surgical therapy
found no significant difference in duration of PPI between the
two groups; the median time to continence was 30 and 31 d, Current EAU guidelines recommend surgical treatment if
respectively [37]. Regarding the effect of PFMT in the long- initial conservative treatment strategies failed [5]. Offering
term period after RP, Goode et al. found in a randomized high continence rates as well as long-term follow-up
controlled trial that PFMT and behavioral therapy reduced evidence, the AUS has been the therapeutic gold standard
incontinence episodes even for patients experiencing PPI >1 for many years [47]. However, in recent years, male slings
yr, highlighting the beneficial effect of PFMT on PPI even a have emerged as an important alternative treatment option
long time after RP [28]. Thus there is currently level-1 and are gaining worldwide popularity. The following
evidence that, prior to offering invasive therapy, all patients section summarizes current evidence regarding outcomes,
should undergo a course of PFMT. complications, and limitations of the respective devices.
Debate is still ongoing whether to combine PFMT with Figure 2 shows a flowchart that provides recommendations
additional biofeedback training. Goode et al. randomized for different clinical situations based on expert opinions.
208 patients into three groups (8 wk of PFMT and behavioral We point out that there might be a different ideal device for
therapy, additional biofeedback and electrical stimulation each individual patient. Based on the respective clinical
therapy, and control) and found no benefit after addition of situation, a retrourethral transobturator male sling, an
biofeedback and pelvic floor electrical stimulation adjustable male sling, or an AUS might be the preferred
[28]. However, there are also randomized trials indicating device.
better continence results after additional biofeedback
therapy [32,38]. 3.3.1. Artificial urinary sphincter
Evidence is also conflicting regarding the potential The perineal AUS is the current established standard in the
benefit of electrical stimulation therapy. Although there treatment of moderate to severe PPI [5]. The AMS 800
are studies indicating better continence improvement (Boston Scientific, Marlborough, MA, USA, formerly AMS,
through electrical stimulation therapy [39,40], there are USA) is by far the most commonly used device; however,
also studies showing no benefit after electrical stimulation alternatives are now available [48,49].
therapy [28,41,42]. Current EAU guidelines recommend not Table 1 summarizes selected contemporary studies
using electrical stimulation therapy alone in the treatment investigating the outcomes after AMS 800 implantation
of male SUI (GR: A) [10]. with a minimum follow-up of 2 yr [25,50–57]. Most of them
were included in a 2013 meta-analysis by van der Aa et al.
3.2.2. Pharmacotherapy [47]. Definition of success was based on pad usage in all
According to current EAU guidelines, concomitant OAB analyzed studies, and dry rates varied between 4.3% [51]
symptoms should be treated with antimuscarinics [10]. In and 85.7% [58]. Notably, these case series were very small
mixed urinary incontinence, the most bothersome symp- (23 and 21 patients, respectively). Only one study reported
tom should be treated first [10]. Regarding SUI after RP, no the outcome of >100 patients; it observed a dry rate of
approved pharmacotherapy yet exists. Duloxetine, a sero- 57.3% [59]. Pooled analysis by van der Aa et al. revealed a
tonin-noradrenaline reuptake inhibitor, is an approved combined dry rate (based on pad usage) of 43.5%
treatment in some countries for female SUI, and evidence [47]. Another pooled analysis of complications after
indicates that it also reduces SUI-related symptoms in male single-cuff AMS 800 placement showed urethral erosion/
patient collectives [43–45]. In a recently published ran- infection in 8.5% of the patients, mechanical failure in 6.2%,
domized placebo-controlled double-blind trial, mean re- urethral atrophy in 7.9%, and a global reintervention rate for
duction in incontinence frequencies and impact on QoL any reason in 26.0% [47]. Regarding revision rates, patient
based on standardized questionnaires was analyzed satisfaction correlates with the functional outcome after
[44]. The authors randomized 31 patients with mild to AUS implantation and not with the number of reinterven-
moderate SUI (16 subjects, 80 mg duloxetine for 8 wk vs tions [60].
15 subjects on placebo) and found a significant reduction of Two studies reporting long-term outcome after AMS
incontinence episodes as well as a significant improvement 800 implantation were published recently. Linder et al.
of QoL for the duloxetine treatment group [44]. Treatment analyzed outcome after 1082 AUS implantations with a
was well tolerated; however, there were increased rates of median follow-up of 4.1 yr. The authors found a surgical
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
EUF-100; No. of Pages 15
Fig. 2 – Flowchart based on expert opinions indicating different therapeutic approaches for varying clinical conditions.
revision rate of 31.3% with mechanical failure, erosion/ that does not need intraperitoneal implantation of a
infection, and urethral atrophy the most frequent causes reservoir balloon and therefore spares the abdominal
[56]. Léon et al. analyzed the outcome of 57 consecutive incision. Staerman et al. analyzed the outcome of 36 patients
patients after a median follow-up of 15 yr. At the end of the [48]. After a mean follow-up of 15.4 mo, social continence
follow-up, 41% of the patients had their native AUS in situ, (0–1 pad per day) was achieved by 73% at 6 mo after device
47% had a revised active AUS in situ, and 12.3% had their activation [48].
AUS explanted. The median time to erosion was >6 yr, The FlowSecure device (Barloworld Scientific, Stafford-
indicating that actual erosion rates might be higher than shire, UK) was introduced in 2006 by Knight et al. and
expected based on current literature [57]. consists of a one-piece silicone device that comes prefilled
In 2003, the transscrotal (also known as penoscrotal) with 30 ml saline. It also includes a stress-release balloon to
approach was described by Wilson et al. [61]. However, a cope with changes in intra-abdominal and intravesical
recent multicenter study including 158 patients indicated pressure changes. Preliminary results of 11 patients found a
that dry rates might be lower with this approach (27.4% reduction of mean daily leakage volume based on 7-d
compared with 44.1% with the classic perineal approach) voiding diaries from 771 ml to 55 ml at 12 mo postopera-
[62]. However, evidence indicates that outcomes might tively. Mean daily pad usage decreased from 3.3 to 1.6 pads
improve after the introduction of the 3.5-cm cuff, and it has per day. No major complications were noted within the first
been suggested that this cuff size should be used if possible 12 mo [64]. Both the FlowSecure and the ZSI 375 AUS have
[63]. been updated in the meantime. However, there is currently
Debate is also ongoing about whether to use a primary no literature available evaluating those updated versions.
double-cuff device or not. Originally intended to improve Complications after AUS placement, frequently urethral
dry rates, there is currently evidence that the double-cuff erosion or device infection, usually lead to explantation of
system might lead to increased complication rates without the whole device. Implantation of a second device is
improving continence rates [52]. associated with a worse outcome [65]. Regarding different
Evidence addressing alternative AUS is still weak and revision techniques after primary AUS failure, Eswara et al.
based on small case series. The ZSI 375 (Zephyr Surgical recently analyzed the outcome of 90 patients who received
Implants, Geneva, Switzerland) is a preconnected device cuff downsizing, pressure-regulating balloon replacement,
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
6
Table 1 – Selected studies analyzing safety and efficacy after artificial urinary sphincter implantation*
Study Device Patients Patients Study design Mean/median Success Definition of Improved, % Explantation, % Comments
included with PPI, % follow-up, yr rate, % success
Lai et al. [50] AMS 800 218 81 Retrospective single 2.2 NS 1 pad NS 27.1, including Previous radiotherapy
center revision in 34% of PPI patients
Table 2 – Contraindications, optional indications, and ideal indications for different surgical treatment options of male stress urinary
incontinence based on current expert opinions
AUS Complete intrinsic sphincter Mild to moderate SUI with high Patients mentally or manually unable to
insufficiency in the level of suffering use the AUS properly
urethroscopic repositioning
test
Complete incontinence
High level of suffering
Adjustable male sling Mild to moderate SUI Patients not able or not willing to Retropubic systems not suitable for patients
undergo AUS implantation with SUI after orthotopic neobladder
Patient able to interrupt urine
stream and capability to
store urine
Previous radiotherapy
Retrourethral transobturator Mild to moderate SUI SUI after TURP or open enucleation Nocturnal incontinence
male sling with positive repositioning test and
coaptive zone >1 cm
Coaptive zone >1 cm during Previous radiotherapy and positive Negative repositioning test with coaptive
repositioning test repositioning test with coaptive zone <1 cm
zone >1 cm
No previous radiotherapy Urine loss >500 ml in 24-h pad test
Compressive balloon Mild to moderate SUI History of previous urethral manipulation Previous radiotherapy
system
History of bulking agents
Bulking agents None Elderly patient; not fit for surgery None
AUS = artificial urinary sphincter, SUI = stress urinary incontinence; TURP = transurethral resection of the prostate.
cuff repositioning, or placement of a second cuff. The seems to be transient urinary retention and transient
authors found that implantation of a second cuff led to more perineal pain [75].
favorable continence results, whereas cuff downsizing led At the end of 2010, the AdVance XP, a second-generation
to an increased rate of mechanical failure [66]. device, was introduced. It includes several innovative
Table 2 summarizes the ideal indications and contra- features such as anchors at the sling arms to reduce early
indications for AUS implantation based on current expert postoperative sling loosening, an updated needle shape to
opinions. facilitate placement in larger and obese patients, increased
sling arm length, and protection sheaths on the sling arms
3.3.2. Retrourethral transobturator slings to cover the anchors during the implantation procedure.
The AdVance sling (Boston Scientific) is the most frequently Efficacy and safety of the AdVanceXP sling has been
used retrourethral transobturator sling worldwide and evaluated in comparative nonrandomized studies
consists of a polypropylene mesh that is placed under the [79,80]. Cornu et al. analyzed 110 patients treated with
membranous urethra after transection of the centrum AdVanceXP and found a cure rate (no pad or one safety pad)
tendineum via a transobturator approach. Regarding its use of 59% after a median follow-up of 16 mo and a transient
for PPI, it is postulated that the AdVance sling acts urinary retention rate of 2% [80]. Bauer et al. reported a
multifactorially via relocating the posterior urethra as well slightly higher cure rate of 65% (no pad or one safety pad)
as the sphincter region into its original position, increasing after a median follow-up of 25 mo and a persistent residual
the venous sealing effect and increasing the functional urine rate of up to 5%. However, the residual urine
urethral length [67]. Despite its frequent use, most evidence disappeared in all affected patients after dissection of one
is currently based on single-center studies (Table 3) with sling arm [68].
only one multicenter study available to date [68–80]. Cure There is evidence that the efficacy of retrourethral
rates vary between 9% and 63% with a follow-up of up to transobturator slings is reduced in patients with previous
40 mo. However, results are difficult to compare because pelvic irradiation therapy [75,81–83], and therefore its use
the definition of ‘‘cured’’ as well as ‘‘success’’ varies is not generally recommended in this patient collective.
significantly between the respective studies. Not all studies Best results can be achieved in patients with good residual
focus on PPI, and there is a significant proportion of sphincter function with long functional sphincter and a
evidence based on mixed patient populations. Regarding mobile posterior urethra. Unlike the adjustable male slings,
the study by Cornel et al, reporting a cure rate of only 9%, the no postoperative readjustment is possible. However,
authors used a very strict definition of success (no pad and regarding the principle of a tension-free repositioning sling,
<2 g urine loss in a 24-h pad test) [73]. AdVance sling a readjustment, in terms of increasing the tension of the
placement seems to be a safe procedure, and severe sling, is not expedient. In case of failure after AdVance sling
complications as well as sling explantations are rare implantation, an explantation of the sling is usually not
(Table 3). The most frequently observed complication necessary and goes along with considerable collateral
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
EUF-100; No. of Pages 15
Table 3 – Selected studies analyzing safety and efficacy after retrourethral transobturator male sling implantation*
Study Device Patients Patients Study design Mean/median Cure Definition of Improved, %
included with PPI, % follow-up, mo rate, % cure
damage. Instead, implantation of a second AdVance sling is (alphabetical order): Argus classic (Promedon, Córdoba,
possible. However, there is evidence that the functional Argentina), ArgusT (Promedon), Phorbas (Promedon),
outcome after second implantation might be less favorable ATOMS (A.M.I., Feldkirch, Austria), and Remeex (Neomedic,
compared with primary implantation [84]. Barcelona, Spain). Current evidence indicates that efficacy
Several additional retrourethral male slings were of the respective slings is comparable (Table 4). However,
recently introduced in the marketplace including the there are differences in the complication rates and types of
TOMS male sling (CL Medical, Sainte Foy Les Lyon, France) complications that are addressed in this review article. Ideal
and the Virtue male sling (Coloplast, Humlebaek, Denmark) indications and contraindications for adjustable male sling
that has four sling arms. Both devices seem to show implantation based on current expert opinions are summa-
comparable results, but further evidence is needed rized in Table 2.
[85–87].
Table 2 summarizes the ideal indications and contra- 3.3.3.1. Argus classic/ArgusT/Phorbas. The Argus classic and
indications for retrourethral transobturator male sling ArgusT adjustable male sling systems consist of a radi-
implantations based on current expert opinions. opaque silicone foam pad attached to two silicone sling
arms (formed by multiple conical elements). Subcutane-
3.3.3. Adjustable male sling systems ously placed radiopaque washers fix the sling arms and
Adjustable male slings are generally inserted suburethrally allow postoperative retensioning when indicated. Whereas
on top of the bulbospongiosus muscle and put pressure the Argus classic is implanted via a retropubic approach, the
primarily on the bulbar urethra and to a lesser extent on the ArgusT male sling system is implanted via a transobturator
more vulnerable membranous urethra to improve basic approach.
continence. Postoperatively, the tension can be adjusted. Currently four studies are available that report outcome
However, current EAU guidelines state that there is no after primary implantation of the Argus classic system with
evidence that adjustability of a sling offers a benefit for the a mean follow-up of up to 45 mo and include a total of >250
patient (level of evidence [LE]: 3) [5]. In contrast to patients (Table 4) [88–91]. Definitions of success vary
nonadjustable retrourethral transobturator slings, good between the respective studies, and therefore comparison is
continence rates can also be achieved in patients with nontrivial. Reported cure rates vary between 17% (defini-
more severe PPI and previously irradiated patients. The tion of success: 0 pads or 1 safety pad per day) [89] and
following adjustable male slings are currently available 79.2% (definition of success: 1 ml in 20-min pad test)
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
EUF-100; No. of Pages 15
11.9, including
failed patients
the patients. Regarding the safety of the Argus classic
system, the rate of intraoperative bladder perforation is
reported to be up to 10%. Consequently, an intraoperative
15.8
15.8
10.4
5.9
11
35
cystoscopy is recommended. The most frequently observed
4
1 readjustment within
1.7: median per patient
38.6%: 9.9% loosening;
Readjustments
functional outcome for the Argus classic male sling with the
nonadjustable AdVance male sling [92]. Patients were
Improved,
26.2
19.6
NS
NS
29
18
13
pad test (2.5 of 345 g vs 2.3 of 325 g). Of 44 men who were
0 pads/d and <10 ml
tion (4% vs 11%) [92]. Lim et al. compared the outcome of the
Success
rate, %
79.2
61.9
64.7
60.5
17
66
follow-up, mo
Mean/median
17
27
35
25
45
32
Prospective multicenter
Prospective two center
95
96
93
NS
74
84
100
38
95
29
101
36
42
51
Argus classic
Argus classic
Argus classic
available.
Device
Remeex
ATOMS
ATOMS
Sousa-Escandon
Hoda et al. [96]
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
10
Table 5 – Selected studies analyzing safety and efficacy after ProACT implantation*
Study Device Patients Patients Study design Mean/median Success Definition of success Improved, % Readjustments Explantation, %
included with PPI, % follow-up, mo rate, %
Hübner and Schlarp [98] ProACT 117 94 Prospective single center 13 67 No pad or one safety pad 25 Mean: 3 27.4
(range: 0–15)
Hübner and Schlarp [99] ProACT 50 100 Retrospective single center 20 60 No pad or one safety pad 22 Mean: 4 24
Kocjancic et al. [100] ProACT 65 92 Prospective single center 20 67 NS 15 Mean: 3 17, including unilateral
(range: 0–8) balloon explantation
sling arms are subsequently placed around the Ramus two scrotal ports and allows repeating volume adjustments
inferior ossis pubis. Readjustment is possible via an inguinal of the device.
or scrotal port. To date, 10 contemporary studies are available providing
To date, evidence is still rare, and currently only two data of >400 patients after a follow-up of up to 57 mo
studies are available describing the outcome of the ATOMS (Table 5) [98–107]. Success rates vary between 60%
system after a follow-up of up to 18 mo and including a total (definition of success: no pad or one safety pad) [99] and
number of 137 patients (Table 4) [95,96]. Definitions of 67% (same definition of success) [98,100]. For instance,
success were comparable in both studies (<10 ml in 24-h Gregori et al. analyzed the outcome of 79 consecutive
pad test vs <15 ml in 24-h pad test), and success rates patients with PPI and observed a dry rate (<8 g in 24-h pad
varied between 60.5% [95] and 63% [96]. However, explan- test and 0 pads or one safety pad per day) of 66%. Regarding
tation rates varied between 4% [96] and 15.8% [95]. Re- the safety of ProACT implantation, the authors found
markably, the inguinal port was used in both studies. The intraoperative bladder perforation in 2.5%, transient urinary
mean number of adjustments varied between 3.8 and retention in 1.2%, device migration in 3.8%, and urethral
3.97 injections per patient [95,96]. erosion in 2.5% [104]. However, complication and consecu-
Regarding the safety of the ATOMS system, the most tive explantation rates were higher in other studies and
frequently reported complications were transient perineal described within a range of 11% up to 58% [98,102]. In this
and scrotal pain (up to 68.7%) as well as postoperative port context, Gregori et al. concluded that complication rates
infections and consequently device explantation (up to might be lower after transrectal ultrasound-guided implan-
10.5%). Current evidence indicates that the ATOMS device tation of the ProACT device [104]. Most recently, Venturino
shows comparable results in previously irradiated patients et al. published the long-term outcome of 22 consecutive
[95,96]. Explantation of the ATOMS device with its mesh patients. Only 4.5% were immediately dry, and 95.5%
arms is more challenging than explantation of a complete needed at least one adjustment. After balloon readjust-
silicone cushioned device. To date, there is no evidence ments, dry rate increased temporarily to 18%, but after a
regarding the outcome after primary ATOMS failure. median follow-up of 57 mo, dry rate decreased again to
4.5%. Overall, 45% of the patients were satisfied; the
3.3.3.3. Remeex. The Remeex system consists of a subureth- remaining 55% were unchanged and dissatisfied. Strikingly,
rally placed mesh connected to a suprapubic mechanical the authors observed revision and explantation rates of 73%
regulator via two bilateral monofilament fibers. The system and 55%, respectively, and they concluded that the ProACT
is implanted via a retropubic approach. The mechanical system does not seem to offer satisfactory results in the
regulator is called ‘‘varitensor’’ and is a suprapubically and long-term follow-up [105]. Based on current EAU guide-
subcutaneously placed, cubically shaped permanent im- lines, the ProACT device should not be implanted in patents
plant. The readjustments are performed via an external with prior pelvic radiotherapy and severe SUI (GR: C) [5].
manipulator. Remarkably, the external manipulator is Table 2 summarizes the ideal indications and contra-
connected to the varitensor during the device implantation indications for ProACT implantation based on current
and left in situ until the first adjustment within the first 48 h expert opinions.
postoperatively. Subsequent adjustments have to be
performed with a single-use mechanical regulator, usually 3.3.5. Bulking agents
under local anesthesia. Due to high initial failure rates and decreasing success rates
To date, only one multicenter study has systematically over time, bulking agents should not be offered to patients
analyzed the outcomes of 51 patients after a mean follow- with severe SUI and patients who are seeking for a cure of
up of 32 mo (Table 4) [97]. Success rate (definition of SUI, but only to patients with mild to moderate SUI seeking
success: 1 pad per day) was 64.7% and therefore temporary relief of symptoms (GR: C) [5]. To date, no
comparable with other adjustable male sling devices evidence indicates that one bulking agent is superior to
[97]. Postoperative complication rates were low; howev- others [5].
er, during the adjustment, rupture or infection of the Table 2 summarizes the ideal indications and contra-
varitensor may occur. The reported explantation rate is indications for bulking agents based on current expert
6% [97]. To date, there is no evidence regarding the use of opinions.
the Remeex system in previously irradiated patients. In
addition, there is no evidence of outcome salvage 4. Conclusions
therapies after primary Remeex failure. Comparable with
the ATOMS device, the explantation of the mesh part is The diagnosis of PPI is currently mostly based on expert
challenging. opinions. Recommended first-line therapy is conservative
treatment, and PFMT is the treatment of choice. Strong
3.3.4. Compressive balloon systems evidence supports its use. Duloxetine remains an off-label
The ProACT system (Uromedica, Plymouth, MN, USA) treatment that should only be offered to patients seeking
represents a noncircumferential compressive device and temporary symptom relief. Antimuscarinics should be
consists of two balloons that are placed bilaterally in the applied to patients experiencing additional urgency.
bladder neck area and consequently achieve continence via Regarding the invasive management of PPI, the AMS
periurethral compression. The system can be readjusted via 800 AUS is still the treatment of choice for moderate to
Please cite this article in press as: Kretschmer A, et al. Evaluation and Management of Postprostatectomy Incontinence: A
Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
EUF-100; No. of Pages 15
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Systematic Review of Current Literature. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.01.002
EUF-100; No. of Pages 15
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