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.