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

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.