Newly-Designed Vaginal Stent To Improve Tissue Healing For Girls And Women With Congenital And Reproductive Anomalie (H-45549)
This study aims to design and test a new vaginal stent for comfort and safety in both pediatric post-surgical patients and adult post-radiation patients.
As many as 50,000 patients per year in North America require the surgical reconstruction of their vaginal canal. Post-operatively, these patients often develop narrowing and scarring of the newly constructed vagina. In hopes of preventing this, physicians place a vaginal stent to keep the walls of the vagina apart and aid in healing. Currently, no pediatric vaginal stents exist and physicians are left to hand-craft a stent that is frequently uncomfortable and/or ineffective.
In addition to post-surgical patients, up to 88 percent of women who undergo pelvic radiation suffer from vaginal shortening and/or narrowing, both of which can be improved with the use of vaginal stents. There exists an adult vaginal stent, however, it is cumbersome, non-ergonomic, and often falls out, all of which lead to poor patient compliance.
This study has two arms. The first of which is designed to determine the most ergonomic and comfortable stent and will be completed by healthy volunteers. The second arm is to test the final stent design in both post-surgical patients and post-radiation patients in the hopes of improving patient outcomes.