(Poster 182) Refined Pelvic Wand: Prototype Development and Human Factors Testing

Objectives: High tone pelvic floor dysfunction (HTPFD), associated with significant healthcare costs and diminished quality of life, affects up to 15% of women in the United States. While pelvic floor physical therapy (PFPT) is the first-line treatment, barriers such as limited access, high costs, and uncertainty regarding proper self-directed techniques hinder patient engagement. To address these challenges, we developed an interactive pelvic floor therapy system with app-based guidance for home use. This study aimed to finalize device design through structured human factors validation testing.

Methods: A formative usability evaluation was conducted on three prototype wand designs to explore usability preferences in 14 HTPFD patients’ experiences with mechanical wands in a single structure interview setting. Each prototype featured distinct variations in handle design, curvature angle, and silicone overmold texture. Prototype A was crafted with a silicone overmold featuring subtle ridges and an angled handle for an ergonomic grip. Prototype B emphasized a more pronounced curvature and an alternative handle position to potentially improve wrist comfort. Prototype C offered a different geometry aimed at reducing strain during insertion and rotation. Central IRB approval was obtained. Participants assessed usability domains wand diameter, curvature, overmold feel, handle grip, ease of insertion, and maneuverability. Qualitative audio feedback was transcribed and analyzed using a summary matrix framework stratified by prototype and design attributes. Data was coded, extracted and summarized into matrices representing specific design constructs.

Results: Thirteen participants (92.8%) found the wand diameter and wand rigidity generally appropriate across all three wand prototypes. The overmold was also the same on each wand with 4/14 (28.6%) participants noting the silicone overmold with ribbing felt "sticky." The handles were different on each of the prototype designs. Prototype A's handle was preferred by 13/14 participants (92.8%) over B and C for its comfort and ease of control. One participant (7.1%) reported improved wrist alignment with C and 7/14 (50%) preferred C to B (Figure 1). Commonly cited areas for improvement included smoother surface textures and less acute curvature near the tip to minimize pain and facilitate correct placement. A revised 3D-printed model of Prototype A was developed (Figure 2).

Conclusions: The insights gained from user feedback on the three unique wand prototypes facilitated human factors validation testing, identifying critical design priorities for a pelvic wand intended for at-home therapy for HTPFD. Adjustments to handle geometry, overmold texture, and shaft curvature were recognized as essential for enhancing comfort and patient adherence. These findings informed the final SmartWand design, optimized for usability in women with HTPFD. Future developments for the SmartWand will concentrate on finalizing the app-based guidance and implementing wireless connectivity, aimed at improving remote therapeutic monitoring and alleviating barriers to care for individuals suffering from HTPFD.