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Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse
Sponsor: Dnipro State Medical University
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2024-09-01
Completion Date
2025-06-30
Last Updated
2026-05-06
Healthy Volunteers
No
Conditions
Interventions
Volumetric Cross-Shaped Vaginal Pessary
A medical-grade silicone vaginal pessary consisting of two intersecting closed rings arranged at approximately right angles around a shared center of symmetry, forming a three-dimensional cross-shaped structure intended to provide multi-vector support for pelvic organ prolapse. The pessary is fitted by a trained gynecologist and participants receive standardized instructions for self-removal, reinsertion, and hygiene.
Locations (5)
City Clinical Hospital No. 6, Dnipro City Council
Dnipro, Ukraine
Clinical Hospital of Emergency Medical Care, Dnipro City Council
Dnipro, Ukraine
City Out-Patient Clinic No. 18, Kharkiv City Council
Kharkiv, Ukraine
Regional Clinical Hospital, Poltava Regional Council
Poltava, Ukraine
State Interdistrict Screening Center
Sheptytskyi, Ukraine