I-Corps: Customer Discovery for a Neovaginal Stent

University Of Minnesota-Twin Cities, Minneapolis MN

Investigators

Abstract

The broader impact potential of this I-Corps project can be seen as a social impact as well as a healthcare impact. Gender affirming care is known to dramatically drop suicidality from 40% to 1.8%. Gender affirming vaginoplasty surgery (surgical creation of a vaginal canal), and its associated post-operative care, has remained largely unchanged since 1966. The complications associated with vaginoplasty can be severe to the point where the patient will require a repeat procedure. The current standard of care to prevent complications requires that the patient lays down in a clean and safe environment, completely relax their pelvic floor, and insert a hard plastic dilator for 30 minutes. Patients are required to do this 3 times a day for the first 3 months. This means that patients are dilating 270 for over 135 hours during the first three months. The device developed here would reduce the number of dilation events from 270 to 2. There were over 20,000 transgender women undergoing this procedure worldwide last year and this incidence is growing at a rate of 24%. With moderate modifications, this device would be appropriate for cis-gendered women to treat radiation-induced vaginal stenosis, Meyer-Rokitansky-Kuster-Hauser syndrome, transvaginal septum, and hemi-vaginal septum. This I-Corps project further develops a medical device designed to prevent complications and reduce compliance barriers associated with the surgical creation of a vagina. The vaginal stent is composed of three distinct components: the rigid removable inner component, the semi-rigid stent component, and the outer silicone component with integrated douching mechanism. The device is inserted into the new vaginal canal during the procedure; at this stage the innermost component is expanded and remains in the patient for the first five days postoperatively before removal. The middle and outer component are replaced every 30 days for the first 90 days postoperatively to continue the expansion of the vaginal canal. Because the device is able to be manipulated to match the needs of the patient through the different phases of healing, this device can replace all aspects of current practices of post-operative care. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.