Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse

Effectiveness and Safety of a Novel Volumetric Cross-Shaped Vaginal Pessary for the Management of Pelvic Organ Prolapse: A Prospective Multicenter Within-Subject Comparison Study

This prospective multicenter single-arm study evaluates the effectiveness and safety of a novel volumetric cross-shaped vaginal pessary in women with pelvic organ prolapse who had prior experience using a traditional vaginal pessary. Each participant serves as her own control by comparing outcomes after fitting of the cross-shaped pessary with documented baseline outcomes during prior traditional pessary use.

Women aged 18 years and older with pelvic organ prolapse stage II or higher and at least 12 weeks of prior traditional pessary use were enrolled at five Ukrainian medical centers. At baseline, the previous pessary was replaced with a volumetric cross-shaped vaginal pessary made of medical-grade silicone. Follow-up assessments were performed at approximately 1 month, 3 months, and 6 months. Assessments included pelvic organ prolapse quantification, Baden-Walker grading, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, pain by visual analogue scale, Patient Global Impression measures, continuation status, patient preference, and adverse events.

Inclusion Criteria:

• Female participants aged 18 years or older
• Pelvic organ prolapse stage II or higher in any compartment
• Current use of a traditional vaginal pessary for at least 12 consecutive weeks before enrollment
• Willing and able to provide written informed consent
• Able to attend scheduled follow-up visits or participate in telephone interviews

Exclusion Criteria:

• Active vaginal or pelvic infection at enrollment
• Pregnancy or planned pregnancy during the study period
• History of pelvic radiation therapy
• Severe vaginal atrophy with active erosion preventing pessary use
• Planned surgical treatment for pelvic organ prolapse during the study period
• Cognitive impairment or psychiatric condition precluding informed consent or protocol compliance
• Known allergy to silicone