Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence

Area of Science:

• Urology
• Gynecology
• Medical Devices

Background:

• Stress urinary incontinence (SUI) significantly impacts women's quality of life.
• Existing SUI treatments may be invasive or require prescription access.
• There is a need for accessible, non-prescription SUI management options.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel over-the-counter (OTC) self-inserted pessary device for treating female SUI.
• To assess the device's impact on leakage episodes, pad weight, and quality of life.

Main Methods:

• A multicenter, single-arm, interventional study was conducted.
• Participants diagnosed with symptomatic SUI used the self-inserted pessary device for 2 weeks after a 1-week baseline.
• Primary outcomes included reduction in leakage events and pad weight by at least 50%.

Main Results:

• The device significantly reduced daily leakage episodes from 2 to 0.9 (P < 0.0001).
• Average pad weight gain decreased from 0.9 g/h to 0.5 g/h.
• 71% of participants experienced >50% reduction in leakage, and quality of life scores improved (P < 0.0001).
• The device demonstrated a favorable safety profile with minimal adverse events.

Conclusions:

• The OTC self-deployable pessary device is a viable alternative for women managing SUI symptoms.
• This device offers an accessible, non-prescription solution for stress urinary incontinence.
• Further research is warranted to assess long-term efficacy and patient compliance.