Vaginal Orthosis After Native Tissue Reconstructive Surgery: Design and Phase 0.

Importance: Pelvic organ prolapse recurrence following native tissue repair occurs with composite failure rates of 9-19% within 12 months, predominantly involving apical/anterior compartments. Objective The objective of this study was to develop a novel vaginal orthosis (NVO) device prototype through an iterative design process based on investigator and user feedback.

Study design: The NVO was designed based on pelvic floor biomechanical principles to mitigate unopposed intra-abdominal pressure of the anterior vagina by absorbing and redirecting intra-abdominal forces to the levator ani and tailored to accommodate postoperative vaginal caliber and axis. Prototypes were fabricated by 3D-printing negative molds, cast, and cured with medical-grade biocompatible silicone. Ten healthy volunteers were recruited to provide qualitative feedback for iterative design refinement (phase 0).

Results: Through an iterative engineering design process, initial concepts were refined to align with the natural, resting H-shape of the vagina. Key features included a distal self-retaining feature, posterior curvature, proximal taper, and apical/anterior contact areas for support. A more rigid material to withstand intra-abdominal forces without folding was required; therefore, Shore A60 (medium soft) instead of A40 (soft) silicone was used. Based on participant feedback, the NVO retaining feature width range was reduced (47.5-63 mm to 45-50 mm) to decrease pressure on lateral vaginal walls and levator ani distally maintaining self-retaining function. Updates to the fitting and education process also provided increased descriptive instructions for insertion and removal.

Conclusions: A novel vaginal orthosis was designed specifically tailored to facilitate wound healing using an orthomedical model, improving the design through iterative feedback.