Sealing the Leak: Sensor‐Aided Vaginal Pessaries for Stress Incontinence Treatment
Lisa Kuchler, Philipp Schäffner, Andreas Tschepp, Daniel Treffer, Samuel Theissl, Anne Hardart, Martin Spoerk, Simone EderABSTRACT
Stress urinary incontinence affects millions worldwide. It can be managed with vaginal pessaries, but clinical effectiveness is limited in part by poor customization of device size, shape, and mechanics. A key barrier to personalization is incomplete knowledge of mechanical forces experienced in the vaginal cavity. Here, we present a smart, personalized vaginal pessary manufactured by extrusion‐based 3D‐printing with integrated flexible piezoelectric pressure sensors to enable real‐time intravaginal force measurements. By selecting ethylene vinyl acetate, which is approved for intra‐vaginal applications, as the structural material and polyethylene terephthalate as the thermally robust sensor substrate, seamless sensor embedding was achieved without compromising device integrity. We produced pessaries of varying infill densities (25 and 100%) to tune stiffness and performed in‐vitro compression tests mimicking physiologically relevant vaginal temperatures and loadings by varying force and cycle number. Sensor sensitivity equivalent to forces required to achieve 10 mm deformation increased with infill density, demonstrating adjustable mechanical behavior. Importantly, embedded sensors showed stable and reproducible sensitivity under repeated compression cycles, indicating suitability for monitoring the repeated loading experienced in situ. This work demonstrates a manufacturable route to instrumented, patient‐specific pessaries and establishes the technical foundation for in‐vivo force mapping that can guide individualized device selection and future closed‐loop therapies.