1. SISPE PROJECT: Use of small intestinal submucosa graft for the surgical management of Peyronie's disease Glina S 1, Toscano IL 1, Baptistussi M 2, Teloken C 3, Jardim CR 4, Faria G 5, Fregonesi A 6, Campos R 7,Torres, LO 8 1Hospital Ipiranga,São Paulo;2Centro Avançado de Urologia,Ribeirão Preto;3Universidade Federal de Ciências da Saúde de Porto Alegre;4 Hospital Universitário Antonio Pedro da Universidade Federal Fluminense,Niteroi; 5 Instituto de Urologia e Nefrologia de Rio Claro; 6 Hospital das Clínicas da UNICAMP,Campinas;7 Hospital dos Servidores do Estado do Rio de Janeiro,Rio de Janeiro;8Hospital Mater Dei/ Hospital Belvedere, Belo Horizonte Source of Funding: Handle-Cook sponsored the study ABSTRACT PURPOSE: Prospective, multicenter study to evaluate the use of Small Intestinal Submucosa (SIS) as a graft for the surgical treatment of Peyronie´s Disease (PD). METHODS AND METHODS: Thirty-seven men with PD from 8 different Brazilian Urological Departments were enrolled in the study. Participants had chronic disease of over 12 month’s duration and presented with stable curvature of at least 45 degrees for at least 6 months. After giving informed consent and answering baseline questionnaires on penile rigidity and erectile function, penis length and extent of curvature were assessed. They were then submitted to a surgical treatment which consisted of plaque incision with SIS grafting. Patients were followed for six months, at which time all baseline tests and questionnaires were repeated. RESULTS: Thirty-five patients completed follow- up; their average age was 55 years (25-72), average time since diagnosis was 27.8 months (12-48), and their curvature was stable for an average of 17.9 months (6-48). Twenty-nine patients had received at least one previous treatment for PD. Average penis length was 10.9 cm (9-14.5) and average curvature was 65 degrees, (45-90). After 6 months, 32 patients had no curvature and could have intercourse, but 5 had recurrent penile curvature. One patient complained of loss of glans sensitivity, 3 complained of pain during erection and 2 complained of penile shortening. The procedure improved the erections in 87.5% of patients. CONCLUSIONS: Surgical plaque incision with SIS grafting was shown to be a safe procedure which corrected penile curvature and maintained penile length. METHODS: This multicentric, prospective study enrolled thirty-seven men with Peyronie´s Disease from 8 different Brazilian Urological Departments. To be enrolled in the study, patients had to have had a history of at least 12 months of disease, with a stable penile curvature of more than 45 degrees that impaired or prevented vaginal penetration for at least 6 months, with painless erections, good penile rigidity, be involved in a stable relationship, and be able to read and fill out questionnaires. On the first visit, patients gave their informed consent, answered the IIEF-5 and additional questionnaires on penile rigidity and pain during erection, and were submitted to an induced erection test with intracavernous injection of Alprostadil. After getting the maximum erection, the length of the penis and the extent of the curvature were assessed. Patients were submitted to a surgical treatment in the second visit, approximately fifteen days following enrollment. Surgery was performed under general or regional anesthesia. The procedure consisted of penile degloving and dissection of dorsal neurovascular bundle or urethra, depending on the curvature. An artificial erection with saline injection was performed through a 21 gauge butterfly with constriction of the base of the penis with a rubber band to reassess penile curvature. An H-incision was made on the area of the maximum curvature, as described by Lue, et al.12 The resultant defect was measured. It was then covered with SIS graft (Surgisis®) sized 30% larger than the albuginea defect area, and secured with 4-0 polyglycolic running suture. After the grafting, another artificial erection was performed to assess penile straightness. A Foley catheter was placed and a compressive dressing was applied and left in place for 24 hours. All patients received oral cephalosporin for 5 days. Patients were followed for six months, at which time all baseline tests and questionnaires were repeated. They were also asked specifically if the treatment improved their erection. They were also submitted to a new pharmaco-induced erection test, during which the length of the penis was assessed. Residual curvature was considered significant if the patient complained or it was more than 30o. This protocol was approved by the IRB Committee of the Coordinator Center of the Project. RESULTS: Thirty-five patients completed the follow-up. Their average age was 55 years (25-72), average time since diagnosis of PD was 27.8 months (12- 8), and their curvature was stable for an average time of 17.9 months (6-48). Pre-operative average IIEF-5 score was 17.6 (Table 1). Twenty-nine patients had received at least one previous treatment for PD (Table 2). Their average penis length was 10.9 cm (9-14.5), and average curvature degree was 65o (45-90). All curvatures were dorsal. Average area of the SIS graft implanted was 10.22cm2 (6-27). In 5 patients, 2 grafts were necessary to achieve penile straightness. Two patients presented with a small area of skin necrosis in the first few post-operative days, which were treated conservatively with good healing. Another two patients presented with large penile hematomas and they were treated with non-steroidal anti-inflammatory drugs. One of these patients had a good resolution after 2 weeks, while the other had a retraction of the penis which was managed with the use of vacuum device twice a day, 30 minutes each day, for 30 days. This patient also complained of penile shortening. Other complications were mild as transient penile edema and tolerable post-operative pain. After 6 months, 30 patients had no curvature and could have vaginal penetration, 5 had significant penile curvature (average: 60o, from 40o to 80o) and three of those patients were submitted to a Nesbitt procedure. Only 1 patient complained of loss of glans sensitivity, 3 complained of pain during erection and 2 complained of penile shortening. Average penile length was 11.7cm (8.5-15), and average IIEF-5 score was 19.4. The procedure improved the erections in 87.5% of the patients (Table 1). CONCLUSIONS: The SISPE Project for surgical treatment of penile curvature due to PD, with plaque incision and grafting with SIS, showed SIS grafting with plaque incision to be a safe procedure, which corrected penile curvature and was effective at maintaining penile length. PreoperativePost-operative Age (years)55 (25-72)N/A Average time of PD (months) 27.8 (12-48)N/A Plaque stabilization (months) 17.9 (6-48)N/A IIEF-5 score17.619.4 Penile length (cm)10.9 (9-14.5)11.7 (8.5-15) Yes, the procedure improved my erection N/A31/35 N/A: Not Applicable Table 1: Preoperative and post-operative patient data