Vesicovaginal fistulas (VVFs), abnormal openings between the vagina and bladder, disrupt the lives of millions of 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, the immediate incontinence often leads to ostracization from the community, and can be devastating for the patient. To occlude the fistula and enable full continence until the patient is able to access surgery, we have designed a three-tiered silicone plug consisting of a bladder-dwelling disc, a mid-fistula disc, and a vagina-dwelling cross-shaped tapered plug, all supported on a central stem.
The 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 100 cmH2O or 9.8 kPa. It is designed to be easily deployed by trained community members without medical qualifications.