PURSUIT is a randomized, double-blinded, sham-controlled, IDE-cleared trial that enrolled 415 subjects with moderate SUI at approximately 30 study sites in the United States. Subjects were randomized in a 2:1 ratio to the active Viveve treatment or an inert sham treatment.
The internationally patented Viveve® System incorporates Cryogen-cooled Monopolar Radiofrequency (CMRF) technology to uniformly provide an endovaginal treatment that is non-ablative.