Multicenter Prospective Study of Grafting With Collagen Fleece TachoSil in Patients With Peyronie's Disease.

A xenograft consisting of equine collagen coated with human fibrinogen and thrombin (TachoSil; Baxter, CA) has recently been introduced in grafting procedures for Peyronie's disease (PD).

To describe the results of a multicenter prospective registry on patients with PD undergoing plaque incision or and grafting (PIG) or plaque excision and grafting (PEG) with collagen fleece TachoSil, to evaluate the efficacy and safety of this procedure.

A prospective non-controlled multicenter study of patients with PD was performed between May 2016 and March 2018. Patients from 10 centers with stable PD for at least 3 months, difficulties in sexual intercourse, normal erectile function with or without pharmacological treatment, curvature >45°, and/or penile shortening and/or complex deformities were included. All patients underwent PIG/PEG with collagen fleece TachoSil.

The main outcome measure of this study were penile curvature correction (intraoperative), penile shortening (intraoperative), erectile function with the 5-item version of the International Index of Erectile Function (IIEF-5) and the Erection Hardness Score, subjective patient outcomes with non-validated questionnaires, and complications.

A total of 52 patients were enrolled in the study. The mean (SD) preoperative penile curvature was 72.8° (17.0). PIG was the preferred technique (80.8%). Intraoperatively, complete curvature correction was achieved in 92.3%, and no significant penile shortening was recorded in 80.8% of subjects. Subjective penile shortening was reported in 83.3% of patients at 6 months. No objective measurement of penile curvature and length was recorded during follow-up. No statistically significant difference from the baseline was found in IIEF-5 and Erection Hardness Score at 3 or at 6 months, although 16.7% of men experienced a worsening of IIEF-5 scores and 14.3% required de novo phosphodiesterase type 5 inhibitor use. 6 months after surgery, 78.5% of men were satisfied with intervention. Swelling and ecchymosis/hematoma were the most common perioperative complications (40.4%). 2 cases (3.8%) of wound infection were recorded. At 6 months, 35.7% of patients reported mild penile hypesthesia.

Our results confirm the high success rate of grafting with TachoSil, and the surgeon perceived low percentage of penile shortening.

This is the first multicentre study on patients with PD undergoing grafting with TachoSil without concomitant placement of penile prosthesis. The main limitations are the short follow-up and the relatively small sample size.

Grafting with TachoSil after PIG/PEG in patients with PD is an effective and safe procedure. Among the main advantages of this technique, there are ease of use of the graft and reduced operative time. Fernández-Pascual E, Manfredi C, Torremadé J, et al. Multicenter Prospective Study of Grafting With Collagen Fleece TachoSil in Patients With Peyronie's Disease. J Sex Med 2020;XX:XXX-XXX.

The journal of sexual medicine. 2020 Aug 20 [Epub ahead of print]

Esaú Fernández-Pascual, Celeste Manfredi, Jose Torremadé, François Peinado Ibarra, Joaquim Sarquella Geli, Javier Romero-Otero, Rodrigo García-Baquero, Agustín Fraile Poblador, Mariano Roselló Barbará, Félix Campos-Juanatey, Alejandra Egui Rojo, Ignacio Moncada Iribarren, Joaquín Carballido Rodríguez, Juan Ignacio Martínez-Salamanca

Department of Urology, Puerta de Hierro-Majadahonda University Hospital, Madrid, Spain; Lyx Institute of Urology, Facultad de Medicina, Universidad Francisco de Vitoria, Madrid, Spain., Urology Unit, Department of Neurosciences, Reproductive Sciences, and Odontostomatology, University of Naples "Federico II", Naples, Italy., Department of Urology, Bellvitge University Hospital, Barcelona, Spain. Electronic address: ., Department of Urology, Ruber Juan Bravo Hospital Complex, Madrid, Spain., Department of Urology, Fundació Puigvert, Barcelona, Spain., Department of Urology, Doce de Octubre University Hospital, Madrid, Spain., Department of Urology, Puerta del Mar University Hospital, Cádiz, Spain., Department of Urology, Ramón y Cajal University Hospital, Madrid, Spain., Department of Urology, Instituto Médico Roselló, Palma de Mallorca, Spain., Department of Urology, Marqués de Valdecilla University Hospital, Santander, Spain., Department of Urology, Fuenlabrada University Hospital, Madrid, Spain., Department of Urology, La Zarzuela University Hospital, Madrid, Spain., Department of Urology, Puerta de Hierro-Majadahonda University Hospital, Madrid, Spain.

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