In vivo Assessment of PCL Cog Thread Reinforcement using an Intravaginal Force Measurement Device

Pelvic organ prolapse (POP) is a common condition that affects millions of women worldwide, significantly impacting their quality of life and creating a critical demand for innovative treatment options. The use of synthetic meshes in POP repair has been associated with complications, leading the FDA to ban transvaginal meshes for prolapse repair in April 2019. The objective of this study was to evaluate an alternative surgical intervention technique by applying injectable biodegradable cog threads, commonly used in facelift procedures, to reinforce the vaginal wall. An in vivo analysis was conducted in sheep, divided into two groups: one without (w/o) cog threads (control group) and one with (w/) cog threads. The goal was to assess the efficacy and potential of cog threads in improving vaginal wall integrity in an animal model. To achieve this, a novel prototype device for intravaginal force measurement was used. The device, a sensor-equipped medical speculum, measures intravaginal forces at varying speculum openings. The results show that intravaginal force increases as the speculum opening widens, with a force of 0.379 N at a closed or no opening and 0.703 N at a 20 mm opening, reflecting an approximate 46% increase. The analysis revealed higher force in the lower vaginal wall, with a maximum variation of 24% at a 20 mm opening and 22% at a 30 mm opening. Additionally, the implantation of cog threads led to a 42% increase in vaginal wall reinforcement. These findings highlight the potential of PCL cog threads to reinforce the vaginal wall after implantation, offering a promising new approach to managing POP with applications in diagnostics, treatment, and biomaterial development.