Stesura Seveso


Archivio Italiano di Urologia e Andrologia 2020; 92, 4386

ORIGINAL PAPER

No conflict of interest declared.

DOI: 10.4081/aiua.2020.4.386

Comparison of penile prosthesis types' complications: 
A retrospective analysis of single center
Erdem Kisa, Mehmet Zeynel Keskin, Cem Yucel, Murat Ucar, Okan Yalbuzdag, Yusuf Ozlem Ilbey

Tepecik Training and Research Hospital, Urology Department, Izmir (Turkey).

leable)”. Inflatable prostheses are further classified into
two groups as two-piece and three-piece prostheses.
Although semirigid (malleable) PPs are more durable and
less expensive, they can experience more erosion as they
are constantly rigid. On the other hand, inflatable PPs
allow use in flaccid and erect states and offer cosmetic
advantage, however, possessing a more complex struc-
ture may result in mechanical failure over time (2-6).
Currently, two-piece and three-piece PPs constitute 75%
of PPI surgeries worldwide, while in our country, semi-
rigid (malleable) PPs are used at higher rates due to the
reimbursement conditions of the social security institu-
tion and the higher cost of inflatable PPs (7-11).
Although PPI surgery is associated with patient and part-
ner satisfaction, certain complications may arise during
and after this operation (12-14). These include; intraop-
erative complications such as urethra perforation, caver-
nosal crossover, and crural perforation, as well as com-
plications encountered in the postoperative period such
as wound site infection, hematoma, lower urinary tract
symptoms, bending during intercourse, breakage of the
prosthesis, concorde deformity, and mechanical failure,
particularly in multi-piece types. Among factors that
influence these complications, the role of diabetes type 2
(DM) and history of radical pelvic surgery (RPS) has been
contended in the literature (10, 15-17).
The aim of this study was to evaluate the clinical out-
comes and surgical complications after PPI performed at
our institution on patients with various causes of ED,
compare complication rates associated with semirigid
(malleable) and inflatable PPs, and investigate the factors
that influence these complications. 

MATERIALS AND METHODS
Approval of the institutional ethics committee was
obtained. We retrospectively reviewed the records of 116
men with ED who had 131 penile prostheses implanted
in our clinic due to end-stage ED between January 2010
and March 2019. The initial surgery included 115 pri-
mary implants and one revision case, who had undergone
the initial operation at another institution. A further 15
men had two revision operations. Three patients with
insufficient data and two cases, who had PPs implanted at
another centre and demanded removal without replace-
ment, were excluded from the study. For all the patients,
demographic characteristics, duration of ED time, size of
implanted PP, complications data, and patient satisfaction

Objectives: The aim of this study was to
compare clinical outcomes and complication

rates associated with semirigid (malleable) and inflatable
penile prostheses (PPs) and investigate the factors that influ-
ence these complications.
Material and methods: The records of 131 patients who had
undergone penile prosthesis implantation (PPI) in our clinic
due to erectile dysfunction (ED) between January 2010 and
March 2019 were retrospectively reviewed. The initial surgery
included 116 primary implants and 15 men had two revision
operations. Patients were assigned to two groups as semirigid
(malleable) PPI (group 1) and inflatable PPI (group 2)
patients, and obtained data were compared across these two
groups.
Results: Group 1 included 93 patients, while Group 2 included
38 patients. Postoperative complication rates of Group 1 were
8.6% (n = 8), and Group 2 were 21% (n = 8), and the compari-
son of postoperative complication rates revealed a statistically
significant difference between the two groups (p = 0.025). 
The majority of these complications (50%) was constituted by
mechanical failure associated with inflatable PPs. When
patients were further segregated as those with and without
diabetes type 2 (DM) and those who had and had not under-
gone radical pelvic surgery (RPS), the comparison of complica-
tion rates across these subgroups did not yield any significant
difference.
Conclusions: We determined in this study that semirigid (mal-
leable) PPs were associated with lower complication rates com-
pared to the inflatable group, particularly with regard to
mechanic failure, and that DM and history of RPS did not
make a difference in complication rates in patients planned to
undergo PPI.

KEY WORDS: Penile prosthesis; Penile prosthesis implant; Erectile
dysfunction; Impotence; Radical surgery; Satisfaction.

Submitted 1 June 2019; Accepted 1 September 2019

INTRODUCTION
Penile prosthesis implantation (PPI) treatment has been
offered for over 40 years with high surgical success in
patients with erectile dysfunction (ED) who either do not
respond to pharmacological treatments such as oral
phosphodiesterase type 5 (PDE5) inhibitors and less
invasive intracavernosal vasocactive agents or reject these
treatments (1). Penile prostheses (PPs) are categorized into
two groups as non-inflatable and inflatable prostheses.
Non-inflatable PPs are also referred to as “semirigid (mal-

Summary



387Archivio Italiano di Urologia e Andrologia 2020; 92, 4

Comparison of penile prosthesis types' complications

were evaluated. Patients were assigned to two groups as
semirigid (malleable) PPI (group 1) and inflatable PPI
(group 2) patients, and obtained data were compared
across these two groups.
Indications for PPI were failure or intolerance of medical
treatment, confirmation of ED by Doppler ultrasound, and
severe ED. All men routinely underwent medical and psy-
chiatric consultation before the surgery. The operative
field was disinfected with povidone-iodine 10 min before
the surgical intervention. Preoperative antibiotic prophy-
laxis, such as vancomycin, was given the night before the
surgery and for 3 days postoperatively. Oral antibiotic
prophylaxis with ciprofloxacin was continued through the
7th postoperative day. All the PPs were implanted through
penoscrotal incisions. The implant and surgical sites were
irrigated with gentamicin in saline prior to implantation.
The corpus cavernosum usually was dilated with Hegar
dilators, though an Otis urethrotome was deemed neces-
sary in two cases. A Foley catheter was inserted at the end
of the procedure and removed 1 day later. The patients
were discharged 1-2 days postoperatively. 
Surgical complications were recorded in detail.
Peroperative and postoperative complications were eval-
uated separately and compared between the groups.
Postoperative complications were divided into two
groups as ‘early’ (complications occurring within 30 days
of surgery) and late (complications occurring after 30
days of surgery).
Prosthesis function was evaluated 1 month after surgery
and then annually until lost to follow-up. Our patients
were asked during control visits if they were satisfied, or
unsatisfied with the prosthesis in general. They were
evaluated at or within 12 months of the postoperative
period, in most cases through face-to-face interviews.
However, in some patients who failed to visit the clinics,
follow-up was assessed through telephone interviews.

Statistical analyses
The groups were assessed for normal distribution using
the Shapiro Wilk test. Statistical difference between the
groups were analyzed with independent sample t test
Mann Whitney U test. Chi-square test was used for cross
comparison. A p-value < 0.05 was considered statistically
significant. All analyses were made by IBM SPSS V22.  

RESULTS
Data obtained from all patients were reviewed to deter-
mine duration of ED time, causes of ED, pre-prosthetic
treatment of primary patients, type of implanted PP, size
of implanted PP, perioperative and postoperative com-
plications (Table 1). The most common factor implicat-
ed in the ED etiology of patients was DM with a rate of
41.2% (n = 54), followed by RPS with a rate of 20.6% (n
= 27). Of 54 DM patients, 26 (48.1%) were on oral
antidiabetics and 28 (51.8%) on insulin therapy. Overall
perioperative complication (urethra perforation and cav-
ernosal crossover) rate was 1.5% (n = 2). In one of these,
where urethra perforation had been encountered during
the cavernousal dilation stage of PPI and the procedure
had been postponed, only one side of the semirigid (mal-
leable) PP could be implanted in the second surgical ses-

sion due to difficulty in dissection. All perioperative
complications were resolved during surgery, and the
operations were completed successfully. The overall
postoperative complication rate was 12.2 % (n = 16).

Table 1. 
Demographics; duration, etiology and treatment of erectile
disfunction (ED); characteristics, complications and 
satisfaction of penile prostheses (PPs).

Number of patients 131
Median age, year (min-max.) 59 (28-74)
Mean ±  SD 58.4 ± 8.3
Median duration of ED time, year (min-max.) 3 (1-21) 
Mean ±  SD 4 ± 3.6
Causes of ED of primary patients, n, (%)
• Idiopathic 22
• Comorbidity 

DM (Diabetes type 2) 54 (41.2%)
Hypertension 26
Myocardial infarction 11
By-pass surgery 5
Chronic obstructive pulmonary disease 2
Cerebrovascular occlusion 1

• RPS (Radical pelvic surgery)
Radical prostatectomy 24 (18.3%)
Radical cystectomy 3 (2.2%)

• Pelvic radiotherapy 7
• Priapism 1
• Peyronie’s disease 9

Penis fracture 1
Pre-prosthetic treatment of primary patients
• Phosphodiesterase 5 (PDE5) inhibitors 114

On-demand 101
Daily 13

• Cavernosal injection 1
• Vascular surgery 1
PPI
• Primary implants 116 (88.5%)
• Revision implants 15 (11.4%)
Type of implanted PP, n, (%)
• Semi-rigid (Malleable) prostheses 93 (70.9%)
• Inflatable prostheses 38 (29%)

Two-piece 36 (94.7%)
Three-piece 2 (5.2%)

Size of implanted PP, n, (%)
• Median size, diameter, cm (min-max.) 10 (9-13)
• Median size, length, cm (min-max.) 18.5 (12-25)
Perioperative complications, n (%), Note 2 (1.5%)
• Urethra perforation 1, During dilatation, postpone
• Cavernosal crossover 1, During dilatation
• Crural perforation 0
Postoperative complications 14 (10.6%)
• Early

Superficial wound infection 4, Resolved with antibiotherapy 
Hematoma located on scrotum 1, Resolved at follow-up

• Late
Bending during intercourse 1, Revision
Lower urinary tract symptoms 1, History of TURP 
Penile prosthesis breakage 2, Revision
Concord deformity 1, Revision
Mechanical failure 4, Revision
Overall complications 16 (12.2%)

Patient satisfication, n (%)
Satisfied 105/131 (80.1%)
Not satisfied 16/131 (19.8%)



Archivio Italiano di Urologia e Andrologia 2020; 92, 4

E. Kisa, M. Zeynel Keskin, C. Yucel, M. Ucar, O. Yalbuzdag, Y. Ozlem Ilbey

388

Revision surgery was needed for 11.4% (15/131) of the
PPs inserted. Of these 15 patients who underwent revi-
sion PPI, 12 had undergone the primary surgery at our
clinic and three at external centers. The median time
until PPI revision was determined as 36 months (1-192
months). Overall, 80.1% (105/131) of the men were sat-
isfied with the results.
Group 1 included 93 patients, while Group 2 included 38
patients. The comparison of data from Group 1 and
Group 2 patients have been summarised in Table 2. In
Group 1, one patient had to be implanted with different-
sized PPs on the right and left sides, whereas in Group 2,
six patients were implanted with PPs of discrepant sizes.
Postoperative complication rates of Group 1 were 8.6% (n
= 8), and Group 2 were 21% (n = 8), and the comparison
of postoperative complication rates revealed a statistically
significant difference between the two groups (p = 0.025).

Among postoperative complications, mechanical failure
was detected in four patients, all of whom were Group 2
patients who had inflatable (two-piece) PPIs. 
When patients were further segregated as those with
and without DM and those who had and had not under-
gone RPS, the comparison of complication rates across
these subgroups did not yield any significant difference
(Tables 3, 4).

DISCUSSION
PPI has been used effectively in patients who do not
respond to oral therapies such as PDE5 inhibitors and to
intracavernosal injection therapy (1). Although this
treatment method offers high patient and partner satis-
faction, it may be associated with certain perioperative
and postoperative complications (2-13). Among these
complications, most notable are the PP infections and
mechanical failure that arise in the postoperative period.
In the recent years, technological advancements in PPs
and advances in the surgical procedure technique have
resulted in a partial decrease in these rates (18).
Although inflatable PPs are utilized more commonly
across the world, semirigid (malleable) PPs have been
utilized at greater rates in our country due to low eco-
nomic status of the patients, high cost of inflatable PPs,
and reimbursement conditions of the social security
institution (7-11). In this study, we aimed to compare
the complication rates associated with semirigid (mal-
leable) and inflatable PPs that we implant at our clinic as
well as to compare these rates between patients with and
without DM and patients with and without history of
RPS. The two groups demonstrated no statistical differ-
ences with regard to perioperative complications.
Comparison of postoperative complication rates across
groups revealed a statistically higher rate for the inflat-
able group. The majority of these complications was con-
stituted by mechanical failure associated with inflatable
PPS. Also, the comparison of complication rates in
patients with or without DM or  history of RPS showed
no difference of overall complication rates.
Although semirigid (malleable) PPs are less expensive and
more durable, they are disadvantaged in terms of cosmet-
ic appearance due to a constant state of erection. On the
other hand, inflatable PPs offer more physiological erec-
tions but may lead to mechanical failure in the postoper-
ative period. In the literature, mechanical failure rates
vary from 0-5% for semirigid (malleable) PPs to 23% for
inflatable PPs (2, 3, 10, 13). A study conducted by Lotan
et al. reported that the complication-free rate was 87% for
semirigid (malleable) PPs, whereas it was 50% for inflat-
able PPs (19). In our study, while no difference was
detected between the groups with regard to perioperative
complications, a statistically higher postoperative compli-
cation rate was determined in the inflatable group (21%)
compared to the semirigid (malleable) group (6.4%). Half
of the postoperative complications in the inflatable group
were accounted by mechanical failure.
In the literature, whether post-PPI infective complica-
tions are more prevalent among patients with DM has
been controversial. Although there are publications that
corroborate the role of DM as a risk factor for postoper-

Table 2. 
Study outcomes by type of prosthesis.

Semirigid PPI Inflatable PPI p
(n = 93) (n = 38)

Median age, year (min-max.) 59 (38-74) 61 (28-69) 0.667
Mean ±  SD 58.6 ± 7.5 58.1 ± 9.8
Median duration of ED time, year (min-max.) 3 (1-20) 2 (1-21) 0.229
Mean ±  SD 4.2 ± 3.5 3.7 ±  4
Size of implanted PP, n, (%)
• Median size, diameter, cm (min-max.) 10 (9-13) 18.5 (12-25) 0.256
• Median size, length, cm (min-max.) 12.5 (12-12.5) 19 (14.5-22) 0.349
Perioperative complications, n (%) 2 (2.1%) 0 0.502
• Urethra perforation 1 (1%) 0
• Cavernosal crossover 1 (1%) 0
• Crural perforation 0 0
Postoperative complications 6 (6.4%) 8 (21%) 0.025
- Early

Superficial wound infection 2 2
Hematoma located on scrotum 0 1

- Late
Bending during intercourse 1 0
Lower urinary tract symptoms 1 0
Penile prosthesis breakage 2 0
Concord deformty 0 1 0.074
Mechanical failure 0 4

Overall complications 8 (8.6) 8 (21%)

Table 3. 
Comparison of overall complication rates of patients 
with and without diabetes type 2 (DM).

DM DM p
(n = 73) (n = 58)

No complication 66 (90.4%) 49 (84.4%) 0.421
Overall complications 7 (9.5%) 9 (5.5%)

Table 4. 
Comparison of overall complication rates of patients 
with and without radical pelvic surgery (RPS).

DM DM p
(n = 73) (n = 58)

No complication 86 (86%) 29 (93.5%) 0,356
Overall complications 14 (14%) 2 (6.4%)



389Archivio Italiano di Urologia e Andrologia 2020; 92, 4

Comparison of penile prosthesis types' complications

ative infections, there are also contradictory studies.
Penidri et al. stated in their metanalysis that DM could be
a risk factor for PP infection, although this could not be
completely clarified (15). The relation of RPS history
with perioperative and postoperative complication rates
has also been contended in the literature. In a study by
Cuneyd et al., erosion rates in semirigid (malleable) PPs
were higher in the RPS group, compared to patients with
other comorbidities, however, postoperative complica-
tion rates were reported to be similar across groups.
They connected these high erosion rates to fibrosis that
develops in the cavernosal tissue after RPS (10). On the
other hand, in a study by Lane et al., it was stressed that
three-piece PP surgery had comparable postoperative
complication rates in patients with and without RPS his-
tory, and therefore, could be utilized safely in these
patients (17). In our study, there were no differences
between patients with and without DM and between
patients with and without history of RPS with regard to
perioperative and postoperative complication rates.
The limitations of our study include its dependence on
retrospective data, lack of partner satisfaction data as it
could not be evaluated for all patients, and absence of
long-term follow up data of patients.

CONCLUSIONS
PPI surgery has been performed worldwide in the treat-
ment of ED, on patients who do not respond to oral and
intracavernosal therapies. Although inflatable PPs pos-
sess a more cosmetic and physiological structure, they
cannot be used in all patients in our country due to their
higher cost and the reimbursement conditions of our
social security system. Semirigid (malleable) PPs consti-
tute the most commonly utilized PPs at our clinic despite
certain disadvantages. In conclusion, we determined in
this study that semirigid (malleable) PPs were associated
with lower complication rates compared to the inflatable
group, particularly with regard to mechanic failure, and
that DM and history of RPS did not make a difference in
complication rates in patients planned to undergo PPI.

REFERENCES
1. Evans C. The use of penile prostheses in the treatment of impo-
tence. Br J Urol. 1998; 81:591-8.

2. Natali A, Olianas R, Fisch M. Penile implantation in Europe: suc-
cesses and complications with 253 implants in Italy and Germany. J
Sex Med. 2008; 5:1503-1512.

3. Atienza Merino G. Penile prosthesis for the treatment of erectile
dysfunction. Actas Urol Esp. 2006; 30:159-69.

4. Lux M, Reyes-Vallejo L, Morgentaler A, et al. Outcomes and sat-
isfaction rates for the redesigned 2-piece penile prosthesis. J Urol.
2007; 177:262-266.

5. Levine LA, Estrada CR, Morgentaler A. Mechanical reliability
and safety of, and patient satisfaction with the Ambicor inflatable
penile prosthesis: results of a 2 center study. J Urol. 2001; 166:932-
937.

6. Gentile G, Franceschelli A, Massenio P, et al. Patient’s satisfac-
tion after 2-piece inflatable penile prosthesis implantation: an
Italian multicentric study. Arch Ital Urol Androl. 2016; 88:1-3.

7. Trost L, Hellstrom WJ. History, contemporary outcomes, and
future of penile prostheses: a review of the literature. Sex Med Rev.
2013; 1:150-163.  

8. Henry GD, Karpman E, Brant W, et al. The who, how and what
of real-world penile implantation in 2015: the PROPPER registry
baseline data. J Urol. 2016; 195:427-433.

9. Menard J, Tremeaux JC, Faix A, et al. Erectile function and sex-
ual satisfaction before and after penile prosthesis implantation in
radical prostatectomy patients: a comparison with patients with vas-
culogenic erectile dysfunction. J Sex Med. 2011; 8:3479-3486.

10. Sevinc C, Ozkaptan O, Balaban M, et al. Outcome of penile
prosthesis implantation: are malleable prostheses an appropriate
treatment option in patients with erectile dysfunction caused by
prior radical surgery? Asian J Androl. 2017; 19:477-481.

11. Anafarta K, Safak M, Beduk Y, et al. Clinical experience with
inflatable and malleable penile implants in 104 patients. Urol Int.
1996; 56:100-104.

12. Scherzer ND, Dick B, Gabrielson AT, et al. Penile prosthesis
complications: planning, prevention, and decision making. Sex Med
Rev. 2019; 7:349-359.

13. Ko OS, Bennett NE Jr. Ambicor two-piece inflatable penile pros-
thesis: background and contemporary outcomes. Sex Med Rev.
2018; 6:319-327.

14. Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and
safety of, and patient satisfaction with the Ambicor inflatable penile
prosthesis: results of a 2 center study. J Urol. 2001; 166:932-7.

15. Pineda M, Burnett AL. Penile prosthesis infections - A review of
risk factors, prevention, and treatment. Sex Med Rev. 2016; 4:389-
398.

16. Bishop JR, Moul JW, Sihelnik SA, et al. Use of glycosylated
hemoglobin to identify diabetics at high risk for penile periprosthet-
ic infections. J Urol. 1992; 147:386-388.

17. Lane BR, Abouassaly R, Angermeier KW, et al. Three-piece
inflatable penile prostheses can be safely implanted after radical
prostatectomy through a transverse scrotal incision. Urology. 2007;
70:539-42.

18. Chung E. Penile prosthesis implant: scientific advances and tech-
nological innovations over the last four decades. Transl Androl Urol.
2017; 6:37-45.

19. Lotan Y, Roehrborn CG, McConnell JD, et al. Factors influenc-
ing the outcomes of penile prosthesis surgery at a teaching institu-
tion. Urology. 2003; 62:918-21. 

Correspondence
Erdem Kisa, MD, FEBU (Corresponding Author)
drerdemkisa@hotmail.com
Mehmet Zeynel Keskin, MD
zeynel_akd@hotmail.com
Cem Yucel, MD
meclecuy@hotmail.com
Murat Ucar, MD
drmuratucar@hotmail.com
Okan Yalbuzdag, MD
drozgurcakmak577@yahoo.com
Yusuf Ozlem Ilbey, MD
ozlemyusufilbey@hotmail.com
Tepecik Training and Research Hospital, Urology Department, 
Yenişehir Mah, Gaziler Cad. No:468, Konak/Izmir (Turkey)