The PP analysis set included all participants from the FA set who used the study device models for at least 20 days, with no significant protocol deviation.

Objective efficacy, or improvement in the prolapsed stage, was evaluated at all study visits using the POP-Q scale. Responsiveness of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) in women undergoing vaginal surgery and pessary treatment for pelvic organ prolapse. This medicine is not recommended to use during pregnancy or breastfeeding unless absolutely required, in which case breastfeeding should be discontinued. ultimately determined by the seller (either private sellers or government agencies) based on their value of the registration mark. ConTIPI Medical’s ProVate Device, for the non-surgical management of Pelvic Organ Prolapse (POP) has a 510(k) clearance from FDA for marketing in the United States, and a CE Mark for marketing in the EU.

Most anticipated AEs within the study occurred during the sizing phase and at the first week of the usage phase. Exclusion criteria included previous inability to accommodate tampons or vaginal pessaries; current participation in another clinical study; comorbid condition(s) or severe systemic diseases that could limit the subject’s ability to participate in the study; pregnancy, suspected pregnancy, or intention to become pregnant during the study; abnormal vaginal bleeding in the previous 6 months; previous vaginal surgery during the preceding 3 months; severely atrophic vagina; existing vaginal or vulvar laceration; symptomatic vaginal or urinary tract infection, as determined by physical examination and lab results; recurrent urinary tract infections; and abnormal cervical cytology.

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