Colloquia

Summary

Stress Urinary Incontinence (SUI) significantly impacts the quality of life for millions of individuals, yet current surgical treatments often involve high morbidity and invasive procedures. This research details the development and evaluation of a non-surgical, patient-controllable, endo-urethral artificial urinary sphincter (AUS) focusing on two critical domains: a robust anchoring mechanism and an intuitive deployment system. A hybrid design, combining the features of an inflatable ring and a membrane skirt, was developed based on a structured evaluation by a panel of nine domain experts. The device was fabricated using multi-material PolyJet 3D printing (Agilus30 and VeroClear) and evaluated within a high-fidelity silicone phantom (Ecoflex 00-30) designed to mimic the biomechanical properties of the urethral complex. Mechanical traction tests demonstrated a mean distal anchoring force of 1.87N, significantly exceeding the theoretical physiological requirement of 0.80N derived from a maximum intravesical pressure of 16kPa. Furthermore, the design demonstrated high functional stability by successfully withstanding a constant 1.25 N load for one hour and twenty repetitions of sudden loading without any measurable migration. Proximal anchoring performance was lower with a mean dislodgement force equal to the 0.80N threshold. Leakage experiments verified that the device remains in place and maintains a seal under pressures up to 16 kPa in silicone phantoms. Sustained testing was hindered by test setup limitations rather than device failure. Usability of the insertion system for the device was assessed through a usability study with novice operators (n = 7). The system achieved a 100% success rate for device insertion and a mean System Usability Scale (SUS) score of 80.4, categorizing the tool as highly intuitive to use and quick to learn. While the removal success rate was lower (71.4%), qualitative feedback identified specific paths for optimization, including the integration of a graduated ruler system for objective depth control and improved tactile feedback for engagement confirmation. These results validate the hybrid anchoring concept as a viable non-surgical approach for urological interventions and provide a robust foundation for future clinical optimization.