A Low-Cost, Easily Deployable Vesicovaginal Fistula Occluding Device for Providing Interim Continence

Abstract

Vesicovaginal fistulas (VVFs), abnormal openings between the vagina and bladder, disrupt the lives of over 3 million people worldwide due to resulting incontinence and infections. VVFs are commonly treated with surgery after the fistula has had time to heal over several months. In low-resource areas, immediate incontinence often leads to ostracization from the community and can be devastating for the patient. To address this problem, we have designed a three-tiered silicone plug consisting of a bladder-dwelling disk, a midfistula disk, and a vagina-dwelling cross-shaped tapered plug, all supported on a central stem. The system is designed to occlude the fistula and enable full continence until the patient is able to access surgery. This proof-of-concept device withstands typical expulsion forces from the bladder and does not leak under typical bladder filling or urination pressures. The maximum device expulsion force is 3.69 N and it is watertight up to 9.8 kPa. It is designed to be easily deployed by trained community members.