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Surgical treatment of Peyronie’s disease with small intestinal submucosa graft patch

Abstract

The objective of the study was to report our results using a porcine small intestinal submucosa graft (Surgisis ES, Cook Medical) for tunica albuginea substitution after plaque incision. We retrospectively evaluated patients surgically treated at our institution for Peyronie’s disease (PD) by means of plaque incision and porcine small intestinal submucosa grafting (Surgisis) between 2009 and 2013. At the same time a literature review was conducted, searching for similar reports and results. Forty-four patients were identified who had been diagnosed with PD between 2009 and the beginning of 2013, and had been treated with corporoplasty, plaque incision and grafting with Surgisis for a severe curvature of the penis. Curvature of the penis was dorsal in 40 patients (90%) and laterally on the right in 4 patients (10%). Mean duration of surgery was 165 min (range 90–200). Mean size of the graft was 6.5 cm2 and the mean follow-up was 19.2 months (range 11–48). In patients with severe curvature of the penis due to PD and the need for corporoplasty with plaque incision and graft placement, Surgisis represents a good option with a low risk of complications, below the rate described with previously investigated graft tissues.

Introduction

Peyronie’s disease (PD) is a condition characterised by an inflammatory response and subsequent plaque formation in the tunica albuginea of the corpora cavernosa that results in a curvature of the penis and, in some cases, ED.1, 2 Although the pathophysiology of PD is still unclear, many authors attribute it to repetitive minor trauma to the erect penis with subsequent tunical delamination and abnormal healing of the tunica albuginea.3, 4, 5, 6 The evolution of PD can be divided into two phases: an acute inflammatory phase, associated with painful erection and ‘initial’ deformity of the penis, and a chronic phase, in which painful erection is substituted by a stable deformity of the penis; sometimes progression may be observed in the chronic phase. Although non-surgical treatment is appropriate during the acute phase, surgical correction of curvature represents the gold standard treatment for chronic disease. In these patients, the aim of surgery is to correct the curvature and allow satisfactory intercourse. As suggested by EAU Guidelines on penile curvature, surgical procedures can be divided into three groups: (a) penile shortening procedures, such as the ‘Nesbit’,7 ‘16-dot’8 and other ‘plication’ techniques described in the literature, which generally entail (the 16-dot technique is an exception) elliptical excisions of the tunica albuginea opposite to the concave corporal segment to treat the curvature; (b) penile lengthening procedures, which involve an incision on the concave side of the tunica albuginea to increase the length of this side while at the same time creating a tunical defect covered by a graft; and (c) penile prosthesis implantation.

Plaque incision alone is no longer used as a treatment because of the high rate of recurrence and the associated ED.9, 10 Plaque incision and grafting is one of the several good alternatives in patients with large plaques, severe curvature or a short penis because a further reduction in penile length subsequent to a plication procedure is unacceptable for these patients.11, 12

The aim of the study was to analyse our results achieved in patients with PD who were treated using a porcine small intestinal submucosa graft (Surgisis ES, Cook Medical) for tunica albuginea substitution after plaque incision and, in addition, to compare our finding with those reported in literature.

Materials and methods

We retrospectively evaluated patients treated at our institution for PD by means of plaque incision and porcine small intestinal submucosa grafting (Surgisis ES, Cook Medical, Bloomington, IN, USA) between 2009 and 2013. At the same time a literature review was conducted, searching for similar reports and results using Pubmed.org and Google Scholar. The following were used as keywords: Peyronie’s disease, penis curvature, plaque incision, grafting penis, Surgisis, biomaterials, alloplastic materials, albuginea substitution, functional results, and ED after grafting. Articles not in English were excluded.

Data recorded by the reviewer during revision were: age of patient, presence of ED (evaluated by IIEF-5 questionnaire), need for medical treatment in the presence of ED, type of agent used in the presence of ED (oral PDE5 inhibitor, intracavernous injection and vacuum device), associated co-morbidities (diabetes mellitus, hypertension, dyslipidaemia, vascular pathologies, Dupuytren’s disease and lower urinary tract symptoms), medical treatment of the patient, plaque location (data obtained by physical examination of the penis), plaque diameter (during surgery, after degloving and before plaque incision), angle of penis curvature during erection (measured on three photographs taken by the paramedic of the Andrology Department at Fundació Puigvert after intracavernous injection of alprostadil: one photo from in front of the penis, one lateral to the penis and one perpendicular to it), type of curvature (dorsal, ventral, lateral, distal and proximal), duration of PD in months, clinical symptoms associated with PD (pain during erection, pain while attempting penetration), post-operative erectile function (evaluated by IIEF-5 questionnaire), post-operative curvature during erection (evaluated by photographs taken by the paramedic of the Andrology Department at Fundació Puigvert after intracavernous injection of alprostadil), stretched (erect) penis length under anaesthesia before and after surgery in both concave and convex site (1–2 months after surgery) and satisfaction after surgery (1=unsatisfied; 2=better than before but lower than 80%; 3=more than 80%).

Surgical procedure

The technical approach to surgery at our institution was similar to that described by other surgeons or by EAU Guidelines for penile lengthening procedures. All patients received a pre-operative antibiotic (at induction of anaesthesia) and general anaesthesia. A subcoronal incision of the penis was performed and circumcision carried out when a redundant prepuce was present; thereafter the shaft of the penis was degloved to its base. A Gittes test involving simulated erection was performed to allow better appreciation of the site and the degree of curvature. After insertion of a butterfly needle into the corpora cavernosa, the base of the penis was constricted with a tourniquet using a Penrose drain and a mosquito clamp to avoid venous leak, and sterile saline solution injected. The neurovascular bundle was then dissected from the corpora cavernosa dorsally or the corpus spongiosum from the corpora cavernosa ventrally. Once the plaque had been identified by manual palpation of the corpora cavernosa, an attempt was made to release neighbouring tissue adhesions and the corpora cavernosa was opened until a straight penis had been achieved. The resulting ‘H-shape’ was then measured in order to calculate the size of the graft material to be used (we use a piece of Surgisis at least 0.5 cm longer and wider than the measured hole). Meanwhile the plaque was dissected, and the Surgisis pack opened and rehydrated with saline solution. The graft was then placed on the penis, surrounding the surgical hole entirely, and anastomosed with one continuous 4-0 Vicryl suture (Ethicon GmbH, Germany). Haemostasis was carefully checked and layered closure of the penis performed using a 3-0 Vicryl rapid suture for the skin. The penis was wrapped, and the 12-Ch Foley catheter removed at 24 h after surgical intervention. The patient was discharged when he started to void voluntarily. We suggested antibiotic and anti-inflammatory treatment for 5 days (penicillin or cephalosporin and ibuprofen or any other non-steroidal anti-inflammatory drug) and evaluated our patients in the outpatient clinic 1 week after surgery. If the pos-toperative course was satisfactory, we suggested that ‘stretching’ of the penis should be performed 3–4 times daily from the second week following surgery; the stretching should be for 10 min on each occasion and should be continued for about 90 days.

Results

Forty-four patients were identified who had been diagnosed with PD between 2009 and the beginning of 2013, and had been treated with a penile lengthening procedure with plaque incision and grafting, with Surgisis for a severe curvature of the penis. Their mean age was 56.1 years (range 49–64 years), and the mean duration of evolution of the penile curvature was 24 months (range 9–48 months). Only 16 of the patients (36%) presented with no related medical disease, whereas 28 (64%) presented with diabetes mellitus, hypertension, dyslipidaemia, heart attack or Dupuytren’s disease. One of them had been submitted to Nesbit corporoplasty in late 2007. Only eight patients (18%) had received no previous medical treatment before surgery, whereas 36 (82%) had done so (Table 1). Treatments used were: tamoxifen, non-steroidal anti-inflammatory drugs, a combination of pentoxifylline and l-carnitine, Glycolix, vitamin E and colchicine.

Table 1 Patient history

Curvature of the penis was dorsal in 40 patients (90%) and lateral on the right in four patients (10%). Correspondingly, plaque was located in the dorsal region in 40 patients (90%) and in the lateral region of the penis in four (9%). The degree of curvature, subjectively estimated from photographs by the same surgeon, was >60° in 40 patients (90%), whereas in 4 patients (10%) data were not recorded because of loss of the photos before surgery (Table 2).

Table 2 Date on penile curvature and surgery

Five patients reported low-grade ED before surgery (12%), whereas 39 (88%) reported ‘normal’ sexual function before surgery at IIEF-5 questionnaire.

Data regarding reduction in penile (stretched penis) size were similar to those reported in the literature13 and no significant contraction was observed after surgery, with a mean reduction of 0.7 cm (range 0.5–1.6 cm).

Mean duration of surgery was 165 min (range 90–200 min). The mean size of the graft was 6.5 cm2 in 43 patients (98%), whereas data were lost for the remaining patients (2%). Mean follow-up was 19.2 months (range 11–48 months).

Regarding complications, 2 patients (4.5%) reported having de novo ED after surgery and required medical treatment with a PDE5 inhibitor, 5 patients (11.3%) presented with oedema post surgery that improved spontaneously, 1 patient (2.2%) presented with local infection that responded to 5 days of oral penicillin treatment, 16 patients (36.3%) presented with local ecchymosis and mild discomfort in the operative area and 3 patients (6%) presented with local pain that improved spontaneously 5 months after surgery. Fifteen patients (34%) presented with no complications (Table 3).

Table 3 Complications after surgery

Discussion

PD is a clinical condition characterised by a deformity of the penis that can be accompanied by difficulty in sexual intercourse and ED. All of these aspects impact negatively on the physical and psychological well being of the patient. Unfortunately, despite the numerous proposed management approaches, no medical treatment is of proven efficacy in reducing the curvature of the penis, though first data recently published on collagenase Clostridium histolyticum injection in patients with PD are encouraging.14 Perhaps, because of this lack of a proven medical treatment, as well as the low spontaneous resolution rate, surgery with corporoplasty, which results in a reduction of penile length mostly with plication techniques, is still considered the only solution to straighten the penis and facilitate penetration. As with medical treatment, numerous surgical techniques have been suggested, but none has been proved to be more effective than the others. Currently, when the curvature is very significant and the loss of penile length after plication is expected to be considerable, a grafting technique should be advised despite the increased risk of subsequent ED. As mentioned above, various graft techniques have been published, over a wide period, involving grafting with biological materials such as tunica vaginalis, temporalis fascia, saphenous vein or porcine small intestinal submucosa, as well as with alloplastic materials such as Gore-Tex (Flagstaff, AZ, USA) or Dacron (Ann Arbor, MI, USA). Because of the good clinical and biological results in terms of reduced operative time (in comparison with, for example, autologous graft), elasticity of the graft and decreased reduction of length in comparison with plication, Surgisis (Cook Medical) is now one of the graft materials most frequently used in cases of severe curvature of the penis due to PD. This biomaterial is a four-layered extracellular matrix 80–100-μm thick that is composed mainly of type I collagen but also of fibronectin, glycosaminoglycans, proteoglycans and growth factors.15, 16, 17 Studies on animals demonstrate that this material is well tolerated, does not provoke a significant inflammatory response or fibrosis and is completely replaced with vascularised connective tissue within 6 weeks after grafting.18, 19

Many authors have described their results in the literature. The largest series, comprising 162 patients, was published by Knoll in 200712 and the same author was the first to describe his experience with this graft material, in 12 patients, in late 2001.20 Other authors have since published their results using Surgisis.21, 22, 23, 24, 25 Results are summarised in Table 4.

Table 4 Authors reporting experience with Surgisis use

In our series of 44 patients, the complication rate was similar to that in other studies: as reported in Table 3, only minor complications were observed and none of the patients required a prolonged hospital stay or reoperation.

We believe that the graft needs to be oversized by 0.5 cm in width and length because of the spontaneous retraction of graft tissue after implantation. We also indicate to our patients that manual ‘stretching’ of the penis/operated zone will be required as early as 7–10 days after surgery. This is done for about 10 min every 8 h, the penis being stretched ‘gently’ in each cardinal direction in order to promote perfect adhesion of the graft tissue to the penis and reduce the retraction of scar tissue. All of the published studies report ED after surgery: Breyer et al.,23 53%; Lee et al.,24 54%; Staerman et al.,22 9.3%; Flores et al.,21 46%; and Knoll,12 20%. However, we believe that ED is independently correlated with the nature of the graft used: it is obvious that if one dissects the dorsal aspect of the penis and then makes an incision or enucleates a dorsally located plaque, it is possible that one will cause a nerve injury that may be responsible for ED; it is also well known that plaque removal may be associated with high rates of post-operative ED due to venous leak.26 We know that cautious dissection of vasculonervous bundle together with watertight anastomosis is required in order to reduce the possibility of de novo ED after plaque mobilisation during surgery. Furthermore, given that it is well known that patients affected by PD are prone to vascular dysfunction and that a vascular injury may be one of the causes of ED, detailed attention must be paid to technique and choice of grafting material if the surgical approach is to be successful.

With the exception of a single report,27 Surgisis is considered a good graft material, and it currently represents one of the best aids available to the surgeon during corporoplasty for severe curvature of the penis: it is a functional biomaterial that is easy to use, is readily available, displays good resistance to mechanical stress, has low antigenicity, is not associated with a significant inflammatory response and offers rapid restoration of normal function because the graft tissue is not drawn from the patient.21, 22, 23, 24, 25

Conclusions

In patients with severe curvature of the penis due to PD and the need for corporoplasty with plaque incision and graft placement, Surgisis represents a good option with a low risk of complications, below the rate described with previously investigated graft tissues.

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Cosentino, M., Kanashiro, A., Vives, A. et al. Surgical treatment of Peyronie’s disease with small intestinal submucosa graft patch. Int J Impot Res 28, 106–109 (2016). https://doi.org/10.1038/ijir.2016.10

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