# Preservation of Cavernosal Erectile Function after Soft Penile Prosthesis Implant in Peyronie's Disease: Long-Term Followup

Authors: Marco Grasso; Caterina Lania; Flavio Fortuna; Salvatore Blanco; Igor Piacentini
Journal: Advances in Urology
 (2008)

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## Abstract

The aim of this retrospective study is to evaluate the long-term followup of soft penile SSDA prosthesis, without plaque surgery in the treatment of Peyronie's disease. This study included 12 men with Peyronie's disease who underwent placement of a penile prosthesis. All patients were followed for at least 6 years. Prosthesis straightened the penile shaft in all cases, restoring patient sexual satisfaction. No operative or postoperative complications occurred, and no reoperations were needed. All patients have undergone further examination with basal and dynamic eco color Doppler. The findings are encouraging as the penis preserves the ability to enhance the tumescence and penile girth. We can conclude that SSDA penile prosthesis is safe and effective in Peyronie's disease.


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## Body

## 1. Introduction

In 1743, de la Peyronie first
described the characteristic penile curvature, nowadays known as Peyronie’s
disease or induratio penis plastica  (IPP) [1]. In
general, IPP refers to acquired penile deformities during erection (curvature
and strictures) and/or penile shortening. This condition is usually associated
with palpable hardening (plaque) on the penile shaft and eventually painful
erection. Current researches suggest that IPP could be a localized connective
tissue disorder affecting the tunica albuginea of the corpora cavernosa.The aetiology of the disease remains unknown
and many hypotheses have been formulated so far. Trauma is thought to be the
promoter factor of IPP, causing mechanical stress and microvascular damage. As
a consequence, even genetically induced, hyperactive wound healing may cause
chronic inflammation and fibrosis of tunica albuginea with subsequent development of hardening and deformation of the penile shaft characteristic of the
stabilized phase of disease.Another hypothesis is related to a defect of
immune response causing antibody reaction against the tunica albuginea. IPP can
occur in a familiar pattern and it has been reported in association with
Dupuytren’s disease as well.Over years, various medical treatments such as
radiation, laser therapy, ultrasound, shock wave lithotripsy have been reported
without any of them being superior to others. However, surgery is considered
the only effective treatment for stabilized disease when severe curvature or
narrowing interferes with sexual intercourse [2–4].Several surgical options have been
proposed. Tunica shortening procedures are performed by reducing the length of
the convex side of the penis opposite to the penile plaque (Nesbitt or Yachia procedures;
plication of corpora cavernosa). Conversely, lengthening techniques are
performed by plaque incision or excision while the resulting defect is then
covered by a graft. As a result, the extension of the short side of the penile
curvature gives the penile shaft the original length [2, 4–6]. Another
possible treatment, especially with associated erectile dysfunction, is penile
prosthesis placement. These surgical treatments warrant adequate correction of penile curvature and
recovery of patient sexual satisfaction [7–9].We have treated a patient series by
placing a particular semirigid soft penile prosthesis (silicon soft dynamic antiextrusion
(SSDA)) in which the cavernous tissue is displaced by prosthesis shaft as a
peripheral layer of cavernous surrounding tissue.Our hypothesis was that the residual
function of this cavernous tissue could have a positive impact on penile
curvature treatment and patient satisfaction. We report our retrospective study
with a long-term followup.


## 2. Material and Methods

Between 1998 and 2001, 12 patients (36 to 67
years) (Table1) were treated by soft penile prosthesis placement (SSDA). All
patients presented erectile dysfunction associated with penile deformation. We
previously excluded patients with diabetes and vasculogenic impotence. A severe
penile shortening was reported in 6 patients. All patients were
previously treated by
various medical and physical therapies without any benefit. In all patients,
the plaque was easily
palpable on the penile shaft. Erectile function was tested by duplex dynamic color Doppler
ultrasound, nocturnal penile tumescence, and hormone assay.Table 1AgeNo. of patients30–40140–50350–60760–701Total12


### 2.1. Description of SSDA Prosthesis and Surgical Procedure

We reviewed our experience with implants on
soft penile prosthesis called silicon soft dynamic antiextrusion (SSDA) (Figure1). This prosthesis consists of silicone elastomer which has three zones
with different features:Figure 1
Prosthesis SSDA.(i)
the
central zone has a variable rigidity
and size to satisfy different clinical necessities and to permit an easy
insertion;(ii)
the
distal zone is made of softer silicone to reduce the risk of
extrusion;(iii)
the
proximal zone presents a series of slightly cone-shaped segments,
with a size of 3 mm, smaller than the central zone, to facilitate the insertion
into corpora cavernosa. It requires less dilatation even in the presence of
severe fibrosis and can reduce crural pain because of better flexibility [7, 8].


### 2.2. Surgical Procedure

A penoscrotal longitudinal incision
is our preferred surgical approach for SSDA prosthesis placement. Trichotomy is
performed two hours before surgery and short-term antibiotic prophilaxis
(Piperacillin 2 g
and Netilmicin 150 mg)
is administered. The patient is placed in lithotomic position under spinal
anaesthesia. We perform a minimal longitudinally corporotomy (<2 cm), on
each corpora cavernosa, and then we place the cylinder with appropriate length
through the corporotomy. Routinely, a transurethral catheter is left in place
until the first postoperative day. Each patient has been followed up until the
surgical wound had healed and any surgical complications have been recorded in
detail. Patients were then taught to manipulate the penile prosthesis and were
allowed to start sexual activity after 6 weeks [10].


### 2.3. Followup

All patients underwent an annual
clinical assessment. All patients reached a 6 years minimum followup. At this
time, a questionnaire was administered to the patient and his partner. The
questions regarded the frequency of sexual intercourse per month, the
acceptance degree by patient and his partner (range 0–10), and the
overall sexual satisfaction. In order to investigate the postoperative residual
function of the corpora cavernosa, all patients were evaluated by color Doppler
dynamic ultrasonography (Esaote-Technos, probe 7, 5–10 MHz) before and after taking oral 50 mg
Sildenafil associated to visual sex stimulation. We measured thickness of
cavernous tissue, peak systolic velocity, and the presence of plaques.


## 2.1. Description of SSDA Prosthesis and Surgical Procedure

We reviewed our experience with implants on
soft penile prosthesis called silicon soft dynamic antiextrusion (SSDA) (Figure1). This prosthesis consists of silicone elastomer which has three zones
with different features:Figure 1
Prosthesis SSDA.(i)
the
central zone has a variable rigidity
and size to satisfy different clinical necessities and to permit an easy
insertion;(ii)
the
distal zone is made of softer silicone to reduce the risk of
extrusion;(iii)
the
proximal zone presents a series of slightly cone-shaped segments,
with a size of 3 mm, smaller than the central zone, to facilitate the insertion
into corpora cavernosa. It requires less dilatation even in the presence of
severe fibrosis and can reduce crural pain because of better flexibility [7, 8].


## 2.2. Surgical Procedure

A penoscrotal longitudinal incision
is our preferred surgical approach for SSDA prosthesis placement. Trichotomy is
performed two hours before surgery and short-term antibiotic prophilaxis
(Piperacillin 2 g
and Netilmicin 150 mg)
is administered. The patient is placed in lithotomic position under spinal
anaesthesia. We perform a minimal longitudinally corporotomy (<2 cm), on
each corpora cavernosa, and then we place the cylinder with appropriate length
through the corporotomy. Routinely, a transurethral catheter is left in place
until the first postoperative day. Each patient has been followed up until the
surgical wound had healed and any surgical complications have been recorded in
detail. Patients were then taught to manipulate the penile prosthesis and were
allowed to start sexual activity after 6 weeks [10].


## 2.3. Followup

All patients underwent an annual
clinical assessment. All patients reached a 6 years minimum followup. At this
time, a questionnaire was administered to the patient and his partner. The
questions regarded the frequency of sexual intercourse per month, the
acceptance degree by patient and his partner (range 0–10), and the
overall sexual satisfaction. In order to investigate the postoperative residual
function of the corpora cavernosa, all patients were evaluated by color Doppler
dynamic ultrasonography (Esaote-Technos, probe 7, 5–10 MHz) before and after taking oral 50 mg
Sildenafil associated to visual sex stimulation. We measured thickness of
cavernous tissue, peak systolic velocity, and the presence of plaques.


## 3. Results

The implantation  of an SSDA prosthesis
straightened the penile shaft in all cases indicating a good surgical outcome  and restored sexual satisfaction. All the patients have been discharged within
the third postoperative day. We did not have any intraoperative complications.
Only one patient had a wound infection without permanent consequences. No
subsequent postoperative complications were encountered. Only one man reported
less than 1 sexual intercourse in a month, 7 men indicated having 1 to 6 sexual
intercourses and 4 men more than 6 sexual intercourses (Table2). The degree of
acceptance by couple was 7, 2 (range 4–10) for men and
7, 8 (range 5–9) for the
partner. The overall sexual satisfaction was positive in 11 patients (Table 3).
The color Doppler dynamic  ultrasonography showed a significant thickness
increase of cavernosal tissue (5 to 9 mm) as well as peak systolic velocity
increase (7.5 cm/s
to 16.5 cm/s) after the dynamic phase; no plaques were
detected (Table 4)
(Figures 2 and 3; Figures 4 and 5). In all cases, we noted
an almost complete straightening of the penile shaft.Table 2No. of sexual intercourses in a monthNo. of patientsLess than
11Between 1
and 67More than
64Table 3MeanRangeAcceptance degree for men (1–10)7,24–10Acceptance degree for partner (1–10)7,85–9Overall satisfaction (yes-no)Yes 11 pts (91%)No 1 pt (9%)Table 4BasalDynamicRangeMeanRangeMeanThickness of cavernosal tissue1,7–2,2 mm1,9 mm2,8–7,2 mm5 mmPeak systolic value6–9 cm/sec7,5 cm/sec13–20 cm/sec16,5 cm/secFigure 2
Basal cavernosal flow.Figure 3
Dynamic cavernosal flow.Figure 4
Basal thickness of cavernosal tissue.Figure 5
Dynamic thickness of cavernosal tissue.


## 4. Discussion

The natural history of IPP can be
summarized into early and late stages. The early stage is characterized by
reactive inflammation with multifocal spreading into the tunica albuginea.
Clinically, a palpable nodule or plaque that makes penis deformed in its shape
during a usually painful erection can be shown. In the second phase, fibrosis
and calcification of acute inflammation take place making the plaque hard and
steadily causing a stable penile curvature, stricture, and some grade
shortening during erection. Reduction of both cavernous blood supply and the
possibility of venous leakage due to the rigidity of tunica albuginea may cause
some grade of erectile dysfunction.This histological evolution seems to
be constant, while the progression and timing of disease remain unpredictable. We
do not have well-defined criteria to establish the end of the process: a quote
of patients indeed presents recurrence after long time. Moreover, in younger
patients, the course may be more severe [11].For these reasons, in our opinion
the surgical treatment of Peyronie’s disease should be as simple as possible,
even considering the possible multifocal spreading of fibrosis. Moreover, in
order to adhere to patient’s perspectives, the ideal prosthetic implant should
provide a firm and straightened penis, if possible, restoring the original
length or girth of the natural erection [12].The SSDA soft prosthesis satisfies
all these criteria as it provides a good hardening and girth of the penis,
implant is easy to perform, it has low cost and low mechanical failure rate
while an adequate flexibility warranted by structure, shape, and by intrinsic
silicone characteristics lead to a good patient tolerance and comfort.
Moreover, after implantation, the residual cavernous surrounding tissue is kept
intact with an adequate cavernous arterial blood flow making possible its
adequate expansion under sexual stimulation. Furthermore, the characteristic
softy tip lowers
the pressure of the prosthetic shaft on the tip of corpora cavernosa with
possible positive impact on pain and eventually on extrusion rate.Our technique does not include the
plaque treatment associated to prosthesis placement. Even in severe penile
curvature, the simple placement of the cylinders makes the penile shaft less
pronounced. Interestingly, we noted that over time the same penile curvature decreases until almost
disappearing. It can be hypothesized that it may be due to continuous
mechanical straighten induced by prosthesis associated with residual cavernous
tissue function.A peculiarity of our study is the
dynamic study of residual cavernous tissue that gives the basis for a role of
pharmacologic rehabilitative postoperative therapy in order to increase
vasoactive response to sexual stimulation and improve patients’ satisfaction.If evaluation of patient
satisfaction might be considered adequate considering the long-term followup,
an even longer followup would be needed to rule out any long-term mechanical
failure as well as spontaneous prosthesis extrusion that did not happen in the
present study.


## 5. Conclusion

Silicon soft dynamic antiextrusion
penile prosthesis is safe and effective in the treatment of severe Peyronie's
disease associated to penile deformity during erection. Results in terms of
penile curvature correction are good. The majority of patients report a sexual
satisfaction. Moreover, the positive response to vasoactive drugs by residual
cavernous tissue might give the rationale for a pharmacological adjuvant
rehabilitation therapy in order to improve the patient satisfaction even in
patients having an insufficient residual cavernous tissue erection.



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