E-Posters-Efficacy & Safety of an Innovative Single-Use Device for The Non-Invasive Management of Pelvic Organ Prolapse

Efficacy & Safety of an Innovative Single-Use Device for The Non-Invasive Management of Pelvic Organ Prolapse - Elan Ziv, MD

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A new disposable vaginal device for the non-surgical management of pelvic organ prolapse (POP) in women has been developed. The device is inserted vaginally and remains in the vagina for up to seven days before being removed. Two home use studies were conducted to evaluate the efficacy and safety of the device. Performance was measured by assessing the change in POP-Q stage of prolapse, and safety was evaluated by recording adverse events. The studies found that the device performed as intended, with clinically significant objective prolapse reduction, and was safe for use with mainly minimal, minor, and anticipated device related adverse events.<br /><br />Study 1 evaluated various aspects of the device, including efficacy, usability, and safety. Subjects used the device for up to 45 days and documented each device’s usage length, functionality, and adverse events in a daily diary. Study 2 compared the device to a commercially available ring pessary and assessed vaginal microflora changes and safety aspects. The results showed that 98.7% of cases experienced a reduction in prolapse to either stage 0 or 1 while using the device.<br /><br />Most device-related adverse events were minor and anticipated, including spotting, discomfort, and some pain. There were no vaginal infections reported, and only one case of urinary tract infection. The majority of adverse events occurred within 7 days from the start of the study, likely due to a learning curve effect.<br /><br />Overall, the device was found to be safe and effective for the non-invasive management of POP in women. The studies were sponsored by ConTIPI Medical Ltd, and conflicts of interest were declared by Elan Ziv and Tsvia Erlich. Nathan Keller had no conflicts of interest.

Keywords

disposable vaginal device

non-surgical management

pelvic organ prolapse

POP

home use studies

efficacy

safety

prolapse reduction

adverse events

ring pessary