Management of Vesicovaginal Fistula in Lower-Resource Settings: A Novel Device for Collection and Drainage of Urine

Abstract

Treatment of vesicovaginal fistula (VVF) is currently limited to surgical repair that is costly and sparsely available and requires intervention from trained specialists, preventing patients in lower-resource settings from receiving effective care. As those who remain untreated continue to experience severe vaginal urinary leakage, an affordable, easy-to-use device that discreetly contains and redirects unwanted leakage of fluids would temporarily alleviate the social distress associated with VVF until patients can afford to present for treatment. We present a novel device to mitigate urinary leakage caused by VVF using a vaginal cup, which allows for the funneling and rerouting of urine into an external drainage bag, to be released at a user's convenience. For patients who cannot afford surgery, our device helps manage their symptoms so that they can reintegrate into society and no longer face the harrowing stigma of their family and society. We demonstrate the effectiveness of our device through preliminary benchtop testing, using a nonliving vaginal model to verify leak-free retainment of the device under varying pressure conditions. Preliminary results indicate that the device displayed no circumferential leakage, and the internal displacement of the cup was within the allotted range of 5 mm for applied hydrostatic pressures up to 150 cm H2O.