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

Max C Cadena1, Christopher X Hong2, Alexandra Blokker2

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Summary
This summary is machine-generated.

A novel vaginal orthosis (NVO) was developed to address pelvic organ prolapse recurrence. Iterative design and user feedback improved the NVO for better wound healing and support.

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Area of Science:

  • Biomedical Engineering
  • Gynecology
  • Pelvic Floor Health

Background:

  • Pelvic organ prolapse (POP) recurrence after native tissue repair affects 9-19% of patients within 12 months.
  • Recurrence predominantly involves apical and anterior compartments.
  • Existing treatments lack adequate support for the anterior vaginal compartment.

Purpose of the Study:

  • To develop a novel vaginal orthosis (NVO) prototype.
  • To utilize an iterative design process incorporating investigator and user feedback.
  • To create a device that mitigates intra-abdominal pressure and supports the anterior vagina.

Main Methods:

  • The NVO was designed using pelvic floor biomechanical principles.
  • Prototypes were fabricated using 3D-printing and medical-grade silicone.
  • Ten healthy volunteers provided qualitative feedback for iterative design refinement.

Main Results:

  • The NVO design was refined to match the natural vaginal H-shape.
  • Material rigidity was increased (Shore A60 silicone) to withstand intra-abdominal forces.
  • Participant feedback led to adjustments in the retaining feature width and improved fitting instructions.

Conclusions:

  • A novel vaginal orthosis (NVO) was successfully designed.
  • The orthosis is tailored to facilitate wound healing using an orthomedical model.
  • Iterative feedback was crucial for optimizing the NVO design.