Repeated penile girth enhancement with biodegradable scaffolds: Microscopic ultrastructural analysis and surgical benefits

Abstract

Autologous tissue engineering using biodegradable scaffolds as a carrier is a well-known procedure for penile girth enhancement. We evaluated a group of previously treated patients with the aim to analyze histomorphometric changes after tissue remodeling and to estimate the benefits of repeated procedure. Between February 2012 and December 2016, a group of 21 patients, aged 22–37 (mean 28.0) years, underwent a repeated penile girth enhancement procedure with biodegradable scaffolds. Procedure included insertion of two poly-lactic-co-glycolic acid scaffolds seeded with laboratory-prepared fibroblasts from scrotal tissue specimens. During this procedure, biopsy specimens of tissue formed after the first surgery were taken for microscopic analysis. The mean follow-up was 38 months. Connective tissue with an abundance of connective tissue fibers, small blood vessels, and inflammatory cells were observed in all analyzed surgically removed tissue. Ultrastructural analysis of these tissue samples discovered the presence of large quantities of collagen fibrils running parallel to each other, forming bundles, with a few widely spread fibroblasts. In total, the mean values of flaccid and erect gain in girth after the second surgery were 1.1 ± 0.4 (range: 0.6–1.7) cm and 1.0 ± 0.3 (range: 0.6–1.5) cm, respectively. Microscopic evaluation of newly formed tissue, induced by autologous tissue engineering using biodegradable scaffolds, showed the presence of vascularized loose connective tissue with an abundance of collagen fibers, fibroblasts, and inflammatory cells, indicating active neovascularization and fibrinogenesis. The benefit of the repeated enhancement procedure was statistically significant.

Male esthetic genital surgery: recommendations and gaps to be filled

“…Interesting prospects come from the biodegradable scaffolds for the generation of new layers of tissue. Despite the excellent results demonstrated through histological analysis of the tissues formed [ 91 ], tissue engineering is expensive, complex, and invasive compared to soft tissue fillers. Additionally, evidence is still limited to few case reports, and we are far from being able to draw conclusions.…”

“… STUDIES n Age (years) Pre-operatory GIRTH THERAPY POST- OPERATORY GIRTH SATISFACTION COMPLICATIONS SOFT TISSUE FILLERS Kwak et al 2010 41 42.5 At midshaft 7.48 (SD 0. 35) cm 20.56 ml of HA +3.92, SD 0.25 cm (1 month) +3.78, SD 0.26 cm (18 month) 18 months 100% patients satisfied (VAS) Not reported Casavantes et al 2015 203 37 Mid 10.54 (SD 1.49) cm 20 ml PMMA Base 13 (SD 1.46) cm Mid 12.76 (SD 1.41) cm 83%patients satisfied (grade 8–10) -Nodules (52%) -Sensitivity decreased (2%) -Erectile function decreased (1.5%) GRAFTS Spyropoulos et al [ 82 ] 5 30 Subcoronal 6.0 (SD 0.4) cm Autologous Dermal fat graft Base + 2.3, SD 0.25 cm Subcoronal +2.6, SD 0.25 cm 7.54 (Post operatory APPSSI) -Curvature with pain (25%) -Pain on erection and hypertrophic scar formation (75%) Alei et al [ 86 ] 60 28.2 Flaccid 8.1 cm Porcine dermal acellular matrix graft Flaccid 11.3 cm Erect 13.2 cm 98% patients satisfied (Post operatory APPSSI) -Moderate fibrosis with minor retractions (6.21%) -Suture dehiscent (5.58%) BIODEGRADABLE SCAFFOLDS Djordjevic et al [ 91 ] 21 28 Flaccid 11.6 (SD 0.8) cm PLGA scaffold + Fibroblasts Flaccid + 1.1, SD 0.4 cm Erect +1.0, SD 0.3 cm 100% patients satisfied (Mark 3–5) -Partial superficial necrosis (10%) Zhe Jin et al 2010 69 33 Flaccid 8.18 (SD 0.83) cm Erect STUDIES ...…”

“…The scaffolds are three-dimensional porous supports made of biocompatible and bioresorbable material able to promote cell adhesion and proliferation up to the formation of a new tissue and micro-network of blood circulation. Cells are first isolated from their natural biological environment, then cultured and implanted on scaffolds, made of a protein matrix capable of promoting their growth directly and indirectly [ 89 – 91 ]. Finally, the scaffolds are placed in the tissue where they degrade, leaving space for the extracellular matrix produced by the cells, thus restoring and implementing the tissue [ 69 ].…”

“…The mean circumference gain was 1.1 (SD 0.4) cm in the flaccid and 1 (SD 0.3) cm in the erect penis after the second surgery at a mean follow-up of 38 months. There were two cases of necrosis of the overlying skin, which was treated conservatively, whereas no alterations in erection or sensitivity were noted with high satisfaction from patients [ 91 ]. Moreover, histological evaluation of what was seeded in the previous surgery revealed a high concentration of Ki-67 and vimentin as signs of cell proliferation, a new extracellular matrix formed by oriented collagen fibrils, a supporting vascular network and disparate fibroblasts and mast cells with probable regulatory activity [ 91 ].…”

“…There were two cases of necrosis of the overlying skin, which was treated conservatively, whereas no alterations in erection or sensitivity were noted with high satisfaction from patients [ 91 ]. Moreover, histological evaluation of what was seeded in the previous surgery revealed a high concentration of Ki-67 and vimentin as signs of cell proliferation, a new extracellular matrix formed by oriented collagen fibrils, a supporting vascular network and disparate fibroblasts and mast cells with probable regulatory activity [ 91 ]. Excellent results were drawn also from the study by Jin et al, who implanted high-interval porosity PLGA scaffolds in 69 patients, with an average circumference gain of 3.15 (SD 0.42) cm and 2.47 (SD 0.49) cm at 6 months, an overall preserved sexual function (IIEF-5 score > 22), a high degree of patient satisfaction and few complication [ 90 ].…”