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.

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

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

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 3rd Faculty of Medicine Charles University Prague Czech Republic

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

Coloplast A S Global R and D Biomaterials Humlebæk Denmark

Department of Materials and Science Engineering Kroto Research Institute University of Sheffield Sheffield UK

Institute of Mechanical Systems ETH Zurich Zurich Switzerland

Institute of Mechanical Systems ETH Zurich Zurich Switzerland; EMPA Swiss Federal Laboratories for Materials Science and Technology Dübendorf Switzerland

The Royal Hallamshire Hospital Sheffield UK

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Evaluation of the short-term host response and biomechanics of an absorbable poly-4-hydroxybutyrate scaffold in a sheep model following vaginal implantation