Lucie Hympánová1, Rita Rynkevic2, Sabiniano Román3, Marina G M C Mori da Cunha4, Edoardo Mazza5, Manuel Zündel6, Iva Urbánková1, Monica R Gallego7, Jakob Vange7, Geertje Callewaert8, Christopher Chapple9, Sheila MacNeil3, Jan Deprest10. 1. Centre for Surgical Technologies, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Department of Development and Regeneration, Woman and Child, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Institute for the Care of the Mother and Child, Third Faculty of Medicine, Charles University, Prague, Czech Republic. 2. Centre for Surgical Technologies, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Department of Development and Regeneration, Woman and Child, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; INEGI, Faculdade de Engenharia da Universidade do Porto, Universidade do Porto, Porto, Portugal. 3. Department of Materials and Science Engineering, Kroto Research Institute, University of Sheffield, Sheffield, UK. 4. Centre for Surgical Technologies, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Department of Development and Regeneration, Woman and Child, Group Biomedical Sciences, KU Leuven, Leuven, Belgium. 5. Institute of Mechanical Systems, ETH Zurich, Zurich, Switzerland; EMPA, Swiss Federal Laboratories for Materials Science and Technology, Dübendorf, Switzerland. 6. Institute of Mechanical Systems, ETH Zurich, Zurich, Switzerland. 7. Coloplast A/S, Global R&D, Biomaterials, Humlebæk, Denmark. 8. Centre for Surgical Technologies, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Department of Development and Regeneration, Woman and Child, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Pelvic Floor Unit, University Hospitals KU Leuven, Leuven, Belgium. 9. The Royal Hallamshire Hospital, Sheffield, UK. 10. Centre for Surgical Technologies, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Department of Development and Regeneration, Woman and Child, Group Biomedical Sciences, KU Leuven, Leuven, Belgium; Pelvic Floor Unit, University Hospitals KU Leuven, Leuven, Belgium. Electronic address: Jan.Deprest@uzleuven.be.
Abstract
BACKGROUND: There is an urgent need to develop better materials to provide anatomical support to the pelvic floor without compromising its function. OBJECTIVE: Our aim was to assess outcomes after simulated vaginal prolapse repair in a sheep model using three different materials: (1) ultra-lightweight polypropylene (PP) non-degradable textile (Restorelle) mesh, (2) electrospun biodegradable ureidopyrimidinone-polycarbonate (UPy-PC), and (3) electrospun non-degradable polyurethane (PU) mesh in comparison with simulated native tissue repair (NTR). These implants may reduce implant-related complications and avoid vaginal function loss. DESIGN, SETTING, AND PARTICIPANTS: A controlled trial was performed involving 48 ewes that underwent NTR or mesh repair with PP, UPy-PC, or PU meshes (n=12/group). Explants were examined 60 and 180 d (six per group) post-implantation. INTERVENTION: Posterior rectovaginal dissection, NTR, or mesh repair. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Implant-related complications, vaginal contractility, compliance, and host response were assessed. Power calculation and analysis of variance testing were used to enable comparison between the four groups. RESULTS: There were no visible implant-related complications. None of the implants compromised vaginal wall contractility, and passive biomechanical properties were similar to those after NTR. Shrinkage over the surgery area was around 35% for NTR and all mesh-augmented repairs. All materials were integrated well with similar connective tissue composition, vascularization, and innervation. The inflammatory response was mild with electrospun implants, inducing both more macrophages yet with relatively more type 2 macrophages present at an early stage than the PP mesh. CONCLUSIONS: Three very different materials were all well tolerated in the sheep vagina. Biomechanical findings were similar for all mesh-augmented repair and NTR. Constructs induced slightly different mid-term inflammatory profiles. PATIENT SUMMARY: Product innovation is needed to reduce implant-related complications. We tested two novel implants, electrospun and an ultra-lightweight polypropylene textile mesh, in a physiologically relevant model for vaginal surgery. All gave encouraging outcomes.
BACKGROUND: There is an urgent need to develop better materials to provide anatomical support to the pelvic floor without compromising its function. OBJECTIVE: Our aim was to assess outcomes after simulated vaginal prolapse repair in a sheep model using three different materials: (1) ultra-lightweight polypropylene (PP) non-degradable textile (Restorelle) mesh, (2) electrospun biodegradable ureidopyrimidinone-polycarbonate (UPy-PC), and (3) electrospun non-degradable polyurethane (PU) mesh in comparison with simulated native tissue repair (NTR). These implants may reduce implant-related complications and avoid vaginal function loss. DESIGN, SETTING, AND PARTICIPANTS: A controlled trial was performed involving 48 ewes that underwent NTR or mesh repair with PP, UPy-PC, or PU meshes (n=12/group). Explants were examined 60 and 180 d (six per group) post-implantation. INTERVENTION: Posterior rectovaginal dissection, NTR, or mesh repair. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Implant-related complications, vaginal contractility, compliance, and host response were assessed. Power calculation and analysis of variance testing were used to enable comparison between the four groups. RESULTS: There were no visible implant-related complications. None of the implants compromised vaginal wall contractility, and passive biomechanical properties were similar to those after NTR. Shrinkage over the surgery area was around 35% for NTR and all mesh-augmented repairs. All materials were integrated well with similar connective tissue composition, vascularization, and innervation. The inflammatory response was mild with electrospun implants, inducing both more macrophages yet with relatively more type 2 macrophages present at an early stage than the PP mesh. CONCLUSIONS: Three very different materials were all well tolerated in the sheep vagina. Biomechanical findings were similar for all mesh-augmented repair and NTR. Constructs induced slightly different mid-term inflammatory profiles. PATIENT SUMMARY: Product innovation is needed to reduce implant-related complications. We tested two novel implants, electrospun and an ultra-lightweight polypropylene textile mesh, in a physiologically relevant model for vaginal surgery. All gave encouraging outcomes.
Authors: B Aghaei-Ghareh-Bolagh; S Mukherjee; K M Lockley; S M Mithieux; Z Wang; S Emmerson; S Darzi; C E Gargett; A S Weiss Journal: Mater Today Bio Date: 2020-10-13
Authors: Kim W J Verhorstert; Martijn Riool; Tess Bulten; Zeliha Guler; Leonie de Boer; Jan-Paul W R Roovers; Sebastian A J Zaat Journal: Mater Today Bio Date: 2022-04-19
Authors: Chantal M Diedrich; Zeliha Guler; Lucie Hympanova; Eva Vodegel; Manuel Zündel; Edoardo Mazza; Jan Deprest; Jan Paul Roovers Journal: BJOG Date: 2021-12-29 Impact factor: 7.331
Authors: Lennart P Maljaars; Stephen T Jeffery; Marlou Scholten; Lisa Kaestner; Khumbo Jere; Deon Bezuidenhout; Zeliha Guler; Jan-Paul W R Roovers Journal: Int Urogynecol J Date: 2022-09-19 Impact factor: 1.932