RECONSTRUCTIVE SURGERY
Major Complications after Male Anti-Incontinence Procedures: Predisposing Factors, Management and
Prevention
Miklós Romics1*, Gergely Bánfi1, Attila Keszthelyi1, Hans Christoph Klingler2, Tibor Szarvas1,
Marcell Szász3 ,Péter Nyirády1, Attila Majoros1
Purpose: Significant post-prostatectomy incontinence (PPI) is a crippling condition and managed best through
sling or artificial urinary sphincter (AUS) implantation. These procedures are often associated with complications
requiring surgical intervention. The aim of our retrospective study was to evaluate the occurrence of major compli-
cations and identify risk factors.
Materials and Methods: Between 2010 and 2018 ninety-one patients have been implanted with sling (22; 24.2%)
or AUS (69; 75.8%) in our department. The cases where surgical revision was needed were examined regarding
the etiology (mechanical failure (MF), urethral erosion (UE), urethral atrophy (UA), surgical site infection (SSI),
combined reasons (COMB) and analyzed, using 16 possible perioperative risk factors.
Results: Surgical intervention was carried out by 19 / 91 (20.9%) patients. (In 16 / 69 cases after AUS (23.1%), 3 /
13 after slings (23%)). The indication was in 6 (31.6%) cases MF, in 3 (15.8 %) COMB, in 4 (21.1%) UE, in 5 (26.3
%) SSI, in 1 (5.2%) UA. The type of reoperation was either explantation (12 / 19), system replacement (6 / 19), or
cuff replacement (1 /19). Regarding the surgical intervention requiring complications only preoperative bacteriuria
(P = .006) and postoperative surgical site oedema (P = .002) proved to be independent predictive factors.
Conclusion: Preoperative bacteriuria and surgical site oedema seemed to be good predictors for obligate surgical
revision. Patients with AUS were more prone to have major complications. In most cases it was mechanical failure,
infection or erosion. By reducing the frequency of these risk factors we might be able to decrease the amount of
complications.
Keywords: post-prostatectomy incontinence, anti-incontinence surgery, implantation, sling, artificial urinary
sphincter, complication
INTRODUCTION
Post-prostatectomy incontinence (PPI) is a frequent and often debilitating complication occurring main-
ly due to radical prostatectomy (RP) or other prostate
operations (transurethral resection of the prostate–
TURP or open prostatectomy – OP). May it be tempo-
rary or permanent, it can have a huge impact on the life
quality, not to mention the financial burden the patient
and the healthcare system has to carry.(1) The incidence
fluctuates between 5 and 40 percent (depending on the
definition), however the urine loss is often slight, and
many of those affected will be continent again at the
end of the first year.(2) Only a small fraction (about 7%)
requires surgical intervention: suburethral sling (much
like the female mid-urethral slings) or artificial urinary
sphincter (AUS) implantation.(3,4,5,6) Despite the long
time it took to achieve relative safety, there are still
numerous complications where we have to intervene.
(5,6) Some of these problems can only be solved with re-
placement, some only with explantation. The revision
rate between AUS (8 - 45 %) and slings (9,7 - 35 %)
differs somewhat with AUS predominance.(7,8)
1Department of Urology and Centre of Urooncology, Semmelweis University, Budapest, HUNGARY.
2Department of Urology, Wilhelminenspital & Krankenhaus Hietzing, Vienna, AUSTRIA.
3Cancer Center, Semmelweis University, Budapest, HUNGARY.
*Correspondence: Department of Urology and Centre of Urooncology, Semmelweis University, Üllői way 78/b Budapest, 1082,
Hungary. Tel: +36204806092. E-mail: miklos.romics@gmail.com. E-mail2: romics.miklos@med.semmelweis-univ.hu.
Received October 2019 & Accepted March 2020
Our goal was to examine the frequency of major com-
plications after male anti-incontinence procedures and
to identify possible risk factors.
MATERIALS AND METHODS
Study Population – Between 2010 and 2018 ninety-one
consecutive PPI patients have been operated in our de-
partment.
Inclusion and exclusion criteria – All of these implan-
tees have been included in our investigation and there
was no reason to exclude anyone of them. (Those,
who were operated but could not receive implant due
to intraoperative complications are obviously got not
involved in our examination.) Data was collected ret-
rospectively. Our patients of the study population (n
= 91) were all Caucasian without significant diversity
across demographic or comorbidity variables. Among
the study population 71 (78%) patients had radical
prostatectomy, 15 (16.5%) had transurethral prostate
resection and 4 (4.4%) had open prostatectomy. (Only a
fraction of these operations were performed at our clin-
ic).
Urology Journal/Vol 18 No. 1/ January-February 2021/ pp. 92-96. [DOI: 10.22037/uj.v0i0.5712]
Vol 18 No 1 January-February 2021 93
According to the 24h PAD test, 66 (72.5%) patients be-
longed to severe (over 400 mL/day), and 25 (27.5%) to
the mild to moderate incontinence group (100 - 400mL/
day).
Procedures – The following implants were used in our
department: the AMS800® (69 pts) artificial urinary
sphincter system (Boston Scientific, Marlborough, MA,
USA), ATOMS® (13 pts) (A.M.I. GmbH, Feldkirch,
Austria) and Argus® (8 pts) (Promedon SA, Cordoba,
Argentina) transobturator adjustable sling systems, and
the Surgimesh M-SLING® (1 patient) (Aspide Médi-
cal, La Talaudière, France), a non-adjustable transobtu-
rator sling. The choice of which device to implant was
based on the level of incontinence (AUS was usually
used for more severe cases, slings for mild or moderate
incontinence but patient’s preference was taken into ac-
count as well. The operations were all performed by the
same surgeon and assistant team. The follow-up time
after the primary operation was avg 39 +/- 22.3 months
(6 - 87 mo).
All operated patients had complete diagnostic assess-
ment preoperatively: physical examination, urine test
and culture, 24-h PAD test and urine loss ratio (urine
loss during 24 hours/total daily urine production), uro-
Table 1. The analyzed perioperative factors and risk analysis (P = < .05)
Perioperative Parameters Value Risk for Major (surgical intervention Risk for obligate intervention Risk for optional intervention
requireing) Complication
Age avg. +/-SD (yr) 69.3+/-5.83 .594 .991 .425
Elderly pts (>75yr) n(%) 21 (23.1) .807 .943 .777
BMI avg.+/-SD (kg/m2) 28.6+/-3.75 .504 .8 .486
Etiology of MSUI .549 .556 .937
RRP n(%) 41 (45.1)
LRP n(%) 29 (31.8)
PRP n(%) 2 (2.2)
TURP n(%) 15 (16.5)
OP n(%) 4 (4.4)
Grade of Incontinence .899 .837 .946
Severe n(%) 66 (72.5)
Moderate n(%) 25 (27.5)
Adjuvant Irradiation n( %) 18 (19.7) .421 .626 .543
Operated anastomotic stricture n(%) 38 (41.7) .432 .357 .944
Previous perineal operation n(%) 11 (12.1) .178 .141 .853
Diabetes n(%) 21 (23.1) .706 .101 .131
Bacteriuria n(%) 42 (46.1) .248 .006 (.025a) .078
Prevoius anticoagulant th n(%) 40 (43.9 .222 .156 .951
Cuff size avg. (up-to) cm 4.5 (3.5-6.5) .582 .728 .686
Surgical Site Oedema (%) 16 (17.5) .072 .002 (.012**) .203
P.op. voiding diff. n (%) 7(7.7) .655 .929 .427
Postop. UTI n (%) 6 (6.6) .793 .794 .464
Postop. pain n (%) 7 (7.7) .655 .929 .427
aSignificant, independent predictive factor in multivariate analyses
Abbreviations: BMI: Body Mass Index, MSUI: Male stress incontinence, RRP: Retropubic radical prostatectomy, LRP: Laparoscopic
radical prostatectomy, PRP: Perineal radical prostatectomy, TURP: Transurethral resection of the prostate, OP: open prostatectomy, UTI:
Urethral tract infection
Figure 1. Complications and their incidence (MF: mechanical failure, SSI: surgical site infection, UE: urethral erosion, COMB: com-
bined reasons, UA: urethral atrophy
Complications after male anti-incontinence procedures-Romics et al.
flowmetry and post-void residual (PVR) urine meas-
urement, upper urinary tract ultrasound, urodynamic
investigation and urethro-cystoscopy. Bacteriuria was
always treated with targeted antibiotic therapy before
the operation and every patient received iv. antibiotics
on the ward and for another 5 days per os after emis-
sion. If urine culture was negative, we automatically
administered prophylactic cephalosporin. (If the urine
culture was positive before the operation, the patient
received preoperative, targeted antibiotic therapy. In
these cases, no control culture has been done right be-
fore the implantation.)
Evaluations – The complications were classified by the
following: infection (INF), urethral atrophy (UA) and
erosion (UE), mechanical failure (MF) and combined
causes (COMB: MF with UE). In our analysis we in-
vestigated all major complications that led to (obligate
or optional) reoperation and looked for possible predis-
posing factors. We have examined the different types
of anti-incontinence operations regarding the frequency
of reoperations as well. A reoperation was obligate, if
INF, UE or COMB type of complications made the in-
tervention a must. It was optional if there was no immi-
nent danger to the patient’s health, but MF or UA made
the continence to significantly deteriorate. In these cas-
es, the surgical goal was to reinstate continence with a
partial or total replacement.
The statistical analysis was performed as described
in the following. For paired group comparisons,
the nonparametric, 2-sided Wilcoxon rank-sum test
(Mann-Whitney test) was applied. To analyze the po-
tential impact of perioperative factors on reoperation
we applied the Chi-square test. Factors occurred less
than 5% in the study cohort, such as postoperative he-
maturia (n = 1), retention (n = 2) and fever (n = 2) were
excluded, leaving 16 factors for analysis. All statistical
calculations were done with the SPSS software pack-
age (24.0; SPSS, Chicago, USA). In all tests, P values
< 0.05 were considered statistically significant. Multi-
variate analysis has been performed with the collected
data.
Patients’ characteristics, the examined perioperative
parameters and their role as possible risk factors are
demonstrated in Table 1. Table 2 shows the relation
between the type of the anti-incontinence surgeries and
the number of reoperations.
RESULTS
Surgical revision was necessary in 19 cases (20,9 %). In
16 (84,2%) Pts with the AUS, and in 3 Pts (23%) after
ATOMS implantation. (With ARGUS or M-Sling there
was no reoperation.) The elapsed time between im-
plantation and reoperation was 14.2 months in average
(0.5 - 43). The most common major complication was
mechanical failure (MF) (6 / 19; 31.6%), followed by
infection (INF) (5 cases; 26.3%). Urethral erosion (UE)
was seen in 4 cases (21%). In 3 occasions a mechani-
cal failure led to urethral erosion (COMB) (15.8%). In
these cases the AUS could not be completely deactivat-
ed after the implantation and it led to urethral erosion
Table 2. The association between the reoperations and the type of the anti-incontinence surgery. a p only for acute obligate reoperation.
(P = < .05)
Comparison of the anti- n (%) vs n (%) Risk for Major compl Risk for obligate reop. Risk for optional reop. requiring
incontinence surgeries requiring complications complications
AMS 800 vs. slings 69(75.8) vs 22(24.2) .377 .074a .777
(ATOMS, ARGUS,M-Sling) .169
AMS 800 + ATOMS vs. simpler 89(90.1) vs 9(9.9) .104 .218 .362
slings (ARGUS, M-Sling)
Figure 2. Types and incidence of reoperations (n = 19)
Complications after male anti-incontinence procedures-Romics et al.
Reconstructive Surgery 94
Vol 18 No 1 January-February 2021 95
– these were categorized as combined complications.
Urethral atrophy was seen only once (5.2%)(Figure 1).
Because of these unfortunate events we had to remove
the implant (EXP) in 12 cases (13.2%). System replace-
ment (REP) was carried out in 6 (6.6%) cuff change
(CCH) in only one case (1.1 %). (Figure 2) Based
on the categories mentioned above, if we elicit the 9
(partly or totally) mechanical complications from the
whole “reoperated” population (19 cases), we end up
with 10 cases (9 AUS, 1 ATOMS), where the root of the
problem lay somewhere else.
Only preoperative bacteriuria and surgical site oedema
proved to be an independent significant predictive fac-
tors in multivariate analysis (P = .025 and P = .012;)
for obligate reoperations.(Table 1) We recognize that
surgical site oedema (or swelling) is a relative term that
has no dimension; however, it is a well-knownphenom-
enon also presented as possible warning sign on the us-
er’s guide for AUS patients. (It was categorized as a
“swelling at the surgical site” – probably due to hemat-
oma, infection or dysfunctional lymph circulation – if
itpersisted over 48 hours postoperatively or was much
bigger in size than what is usually expected after these
operations.)
The type of the implant was also an important (al-
though, not significant) predicting factor, since over
80 percent of our complications happened after AUS
implantations and many of these were mechanical - a
type of problem which usually occurs in a much lower
number with slings.(9)
DISCUSSION
As we come across complications, we should always
look for the origin even if the incidence does not dif-
fer much from the previously published data.(10) In our
experience there are three ways to deal with this ques-
tion. The root of the event can either be a mechanical
problem, human error or the unlucky attributes of the
patient. Since often there are combined reasons, it is not
easy to decide which is which, although it is quite clear
that failures arising from surgical inexperience counts
to the expense of the surgeon, and mechanical failures
can usually be blamed on the manufacturer.In our work,
mechanical failure was the most common complication
which represented the half of all cases (9 out of 19 –
47%) either as a single complication or as a part of it. In
contrast to others, however, we rarely saw erosion under
the cuff (4 / 69). This difference (5.7 vs 10.7 - 10.8 %)
may be related to the fact that others (like McKibben)
used 3.5 – 4 cm cuffs, our average cuff-size was 4.5
cm.(11) Bugeia detected mechanical failures with AUS
in 62 %, mostly due to the dysfunction of the pressure
regulating balloon.(12) Urethral atrophy was only seen
in a few cases, just like in our investigation (1 / 69).
As we present in our study, the factors that showed a
significant correlation with major complications re-
quired obligate surgical revision were the preoperative
bacteriuria and the surgical site oedema which could be
related to the patient’s inadequate preparation giving us
room to improve and change our routine.
When discussing major complications, it is also recom-
mended to distinguish one from the other, based on the
necessity of reoperation: i.e. the indication is obligate
or imperative (the procedure is unavoidable) in case of
acute infection or urethral erosion. Chronic infection,
or skin erosion without signs of acute infection (around
the pump, port or access kit) can be mended with ex-
ploration, debridement, total – or in some selected cas-
es – partial exchange of the device. Evidently, we only
turned to this solution, when the chronical, superficial
skin (or subcutaneous) infection and consequential skin
erosion did not reach the urethra, and the patient spe-
cifically requested the exploration and debridement,
hoping that his continence will be preserved this way.
(Even tough, because of the recurrent problems we lat-
er ended up removing the implant after all.) The other
group of complications which require surgical attention
is where malfunction appears in the form of recurrent
incontinence: the main cause is usually a mechanical
problem or urethral atrophy. (Here we have to add, that
there is growing evidence that many of the cases which
one could easily qualify as atrophy are not atrophies
at all. In fact, it’s only fibrous sheet (a.k.a. capsule)
growing over the inner surface of the cuff that gives
the impression of a urethral atrophy.(11,13)) In these cases
the patient’s health is not in imminent danger, but the
deteriorating quality of life makes the surgical interven-
tion (replacement, or exchange) indisputably needed.
In these cases, the (optional) replacement can be per-
formed in a single operation. These types of complica-
tions (mechanical failures without any infection) were
the most common in our experience (6 / 19) – four with
AUSs and two with ATOMS slings. (Here we would
like to add that AUS systems are notoriously more
prone to suffer mechanical failures (in 12 - 53%) than
any type of slings. This is partly due to their complex
structure and partly to the fact that they have to be as-
sembled on sight.(14,15)
The incidence comparison of complications between
the patients operated early and late in the learning curve
showed no significant difference. This is contradicted
by a large study published in European Urology, which
pointed out the extremely long learning process of AUS
implantation but also called for structured, thematic,
training-based surgical education to reduce the learn-
ing curve.(16) (In our case, we tried to reach the needed
experience by accredited trainings and operating with
practiced guest operators.) Our patients all received tar-
geted or empiric antibiotic therapy however it looks like
some patients (having had significant bacteriuria and
treatment but no control urine culture before the opera-
tion) still suffer more complications. (Probably because
the surgical site is still being contaminated through the
non-sterile urine.) After what we learned we decided
that to do another urine culture before the operation
(even after the targeted antibiotics therapy), to see if
we can improve our numbers. The other independent
risk factor was the postoperative surgical site oedema
(which is a relative concept, though we have tried to
define the phenomenon above). In its development
postoperative hematoma, diminished lymphatic drain-
age, or infection could all play a part to varying degrees.
The possibility of this complication could be reduced
by more precise surgical technique and hemostasis.
Unlike Hüsch et al., we did not find preoperative irra-
diation to be an independent, predisposing risk factor
for complications, however, the role and significance of
the independent risk factors we described are obviously
enhanced in tissues where the circulation is damaged(17).
Whereas most of the previous papers dealing with
complications of male anti-incontinence operations in-
volved only a handful of perioperative factors the cur-
Complications after male anti-incontinence procedures-Romics et al.
rent one has examined 16 parameters. Reconstructive
male urogenital surgery with implants is more effective
than with the use of autografts, however – just as with
female patients, the surgical management of stress uri-
nary incontinence and prolapsed surgery comes with a
number of complications, which we aim to reduce in
the future.(17,18)
Our study’s obvious limitation is the low patient num-
ber. However, we tried to compensate this number with
a large collection of assessed perioperative factors. Our
initial results are promising and we intend to investi-
gate our objectives further with a multicenter study,
including measures designed to reduce complications
mentioned in this study.
CONCLUSIONS
The rate of major complications after male anti-incon-
tinence surgery in our department is in line with the
international data. Among the male anti-incontinence
operations the AUS implantation came with the most
complications (requiring acute surgical revisions) but
the difference has not proved to be significant. The
leading indication for reoperation was the mechanical
failure. Complications without the possible presence of
mechanical failure were seen in only 10 pts (52.6 %).
Between these investigated perioperative factors, only
the preoperative bacteriuria and the surgical site oede-
ma could be identified as independent risk factors to
predict major (surgical intervention requiring) compli-
cations with obligate necessity of surgical revisions.
According to these findings we will alter our clinical
protocol and do a preoperative control urine culture
(just before the patient gets admitted) after the targeted
antibiotic therapy! Also, we will try to reduce the pos-
sible trigger factors leading to postoperative oedemas.
These might help us reduce the number of reoperations
and report about an improving complication rate in our
follow-up publication.
REFERENCES
1. Herschorn S. Update on management of post-
prostatectomy incontinence in 2013. Can Urol
Assoc J. 2013;7:189-91.
2. Anger JT, Saigal CS, Stothers L, et al.
Theprevalence of urinary incontinence among
community dwelling men: results from the
National Health and Nutrition Examination
Survey. J Urol 2006; 176:2103–2108.
3. Bianco FJ, Riedel ER, Begg CB, Kattan
MW, Scardino PT, Scardino PT. Variations
among high volume surgeons in the rate of
complications after radical prostatectomy:
further evidence that technique matters. J Urol
2005; 173:2099-2103
4. Emami M, Momtazan A, Maghsoudi R et
al.A.Transobturator tape and mini-sling
methods in stress urinary incontinence:Results
of a randomized clinical trial.Urologia 2019;
86:152-155.
5. Bauer RM, Rutkowski M, Kretschmer A et al.
Efficacy and complications of the adjustable
sling system ArgusT for male incontinence:
results of a prospective 2-center study.
Urology. 2015;85:316-20.
6. Ravier E, Fassi-Fehri H, Crouzet S, Gelet
A, Abid N, Martin X. Complications after
artificial urinary sphincter implantation in
patients with or without prior radiotherapy.
BJU Int. 2015;115:300-7.
7. Gousse AE, Madjar S, Lambert MM, Fishman
IJ. Artificial urinary sphincter for post radical
prostatectomy urinary incontinence: long-term
subjective results. J Urol, 2001; 166:1755-8.
8. Kretschmer A, Hüsch T, Thomsen F etal.
Targeting moderate and severe male stress
urinary inconetinence with adjustable
male slings and the perineal artificial
urinary sphincter: focus on perioperative
complications and device explantations. Int
Neurourol J 2017, 21:109-115
9. European Association of Urology, Urinary
Incontinence guidelines, 2018
10. Pic G, Terrier JE, Ozenne B, Morel-Journel
N, Paparel P. Impact of anastomotic strictures
on treatment of post-prostatectomy stress
incontinence by artificial urinary sphincter.
Prog Urol. 2016 ;26:635-641.
11. McKibben MJ, Shakir N, Fuchs JS, Scott JM,
Morey AF. Erosion rates of 3.5-cm artificial
urinary sphincter cuffs are similar to larger
cuffs. BJU Int.2019;123:335-341.
12. Bugeja S, Ivaz SL, Frost A, Andrich
DE, Mundy AR. Urethral atrophy after
implantation of an artificial urinary sphincter:
fact or fiction? BJU Int. 2016 ;117:669-76..
13. Comiter CV, Dobberfuhl AD. The artificial
urinary sphincter and male sling for
postprostatectomy incontinence: Which
patient should get which procedure? Invest
Clin Urol. 2016;57:3-13.
14. Abrams P, Andersson KE, Artibani A.
Recommendations of the International
Scientific Committee. Chapter 11B: Surgical
treatment of urinary incontinence in men.
2nd International Consultationon Continence,
Paris, France (2002)
15. Badry MS, E Hefnawy AS, Gabr AH,
Hammady AR. Use of the adjustable
transobturator male sling system for the
treatment of male incontinence. An initial
experience. Afr JUrol 2016; 22: 127–130.
16. Sandhu JS, Maschino AC, Vickers AJ. The
surgical learning curve for artificial urinary
sphincter procedures compared to typical
surgeon experience. Eur Urol. 2011;60:1285-
90.
17. Hüsch T, Kretschmer A , Thomsen F et al.
Risk Factors for Failure of Male Slings and
Artificial Urinary Sphincters: Results from a
Large Middle European Cohort Study. Urol
Int 2017, 99:14-21
18. Oride A, Kanasaki H, Hara T, Kyo S.
Postoperative Outcomes Following Tension-
Free Vaginal Mesh Surgery for Pelvic Organ
Prolapse: A Retrospective Study. Urol J. 2019
24;16:581-585.
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