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Multicenter Prospective Study of Grafting With Collagen Fleece TachoSil in Patients With Peyronie's Disease
Affiliation:1. Department of Urology, Puerta de Hierro-Majadahonda University Hospital, Madrid, Spain;2. Lyx Institute of Urology, Facultad de Medicina, Universidad Francisco de Vitoria, Madrid, Spain;3. Urology Unit, Department of Neurosciences, Reproductive Sciences, and Odontostomatology, University of Naples “Federico II”, Naples, Italy;4. Department of Urology, Bellvitge University Hospital, Barcelona, Spain;5. Department of Urology, Ruber Juan Bravo Hospital Complex, Madrid, Spain;6. Department of Urology, Fundació Puigvert, Barcelona, Spain;7. Department of Urology, Doce de Octubre University Hospital, Madrid, Spain;8. Department of Urology, Puerta del Mar University Hospital, Cádiz, Spain;9. Department of Urology, Ramón y Cajal University Hospital, Madrid, Spain;10. Department of Urology, Instituto Médico Roselló, Palma de Mallorca, Spain;11. Department of Urology, Marqués de Valdecilla University Hospital, Santander, Spain;12. Department of Urology, Fuenlabrada University Hospital, Madrid, Spain;13. Department of Urology, La Zarzuela University Hospital, Madrid, Spain;1. Center for Reproductive Medicine, Baylor College of Medicine, Houston, TX, USA;2. Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA;1. Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal, Madrid, Spain;2. Servicio de Histología-Investigación, Unidad de Investigación Traslacional en Cardiología (IRYCIS-UFV), Hospital Universitario Ramón y Cajal, Madrid, Spain;3. Fundación para la Investigación Biomédica del Hospital Universitario de Getafe, Getafe, Spain;4. Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain;5. Servicio de Urología, Hospital Universitario Doce de Octubre, Madrid, Spain;6. Serviço de Urologia, Hospital Geral de Santo Antonio, Porto, Portugal;7. Servicio de Geriatría, Hospital Universitario de Getafe, Getafe, Spain;1. Department of Urology and National Research Center for Sexual Medicine, Inha University School of Medicine, Incheon, Republic of Korea;2. Department of Urology, Kosin University College of Medicine, Busan, Republic of Korea;3. Center for Biomolecular & Cellular Structure, Institute for Basic Science (IBS), Daejeon, Republic of Korea;4. Department of Life Sciences, Pohang University of Science and Technology, Pohang, Kyeongsangbuk-do, Republic of Korea
Abstract:BackgroundA 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).AimTo 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.MethodsA 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.OutcomesThe 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.ResultsA 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.Clinical implicationsOur results confirm the high success rate of grafting with TachoSil, and the surgeon perceived low percentage of penile shortening.Strength & LimitationsThis 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.ConclusionGrafting 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;17:2279–2286.
Keywords:Collagen Fleece  TachoSil  Graft  Tunical Lengthening  Plaque Incision  Plaque Excision  Peyronie's Disease
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