Ex Vivo Testing of Inflatable Penile Prosthesis in Human Cadaveric Penis with Paired in Silico Model offering Surgical and Biomechanical Insights
BackgroundInflatable penile prostheses (IPPs) are a critical solution for patients with erectile dysfunction refractory to medical therapy. However, a detailed understanding of their mechanical interaction with penile tissues remains limited. AimTo develop and validate an innovative experimental-computational framework for studying IPP behaviour through ex vivo implantation and inflation testing in human cadaveric penile tissue, paired with a finite element-based (FE-based) computational model. MethodsAn AMS 700 IPP was surgically implanted into a human cadaveric penis (including the glans and [~]15 cm of shaft) using standard clinical techniques. The cylinders were placed within the corpora cavernosa, with the pump and reservoir positioned externally in a closed hydraulic loop. An inflation test was performed ex vivo, with real-time ultrasound imaging used to monitor cylinder expansion. Internal pressure was recorded using a digital barometer. Following inflation, sectional analysis enabled 3D approximation of penile shaft geometry. A representative FE-based computational model was developed, incorporating anatomically accurate tissue layers--tunica albuginea (TA), corpus cavernosa (CC), corpus spongiosum (CS), and fascia--with realistic material properties to simulate the inflation process. OutcomesThis study enabled the mechanical response of penile tissues to IPP inflation to be quantified using both experimental and computational modalities. ResultsThe combined use of ultrasound imaging and digital pressure monitoring successfully captured dynamic IPP behaviour during inflation. The FE model reproduced experimental outcomes with good fidelity, providing a detailed understanding of stress distribution and tissue deformation. Clinical ImplicationsThis integrated approach can inform future IPP design improvements and aid surgeons in preoperative planning by offering predictive insights into prosthesis-tissue interaction. Strengths & LimitationsA major strength of this study is the novel integration of cadaveric experimentation with computational modelling. However, limitations include the absence of active physiological responses and potential variability due to cadaveric tissue properties. ConclusionThis pioneering work establishes a robust platform for studying IPP mechanics in realistic anatomical contexts, with promising implications for optimising device design and improving patient outcomes in urologic surgery.