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COMPLETED
NCT07554651
NA

Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse

Sponsor: Dnipro State Medical University

View on ClinicalTrials.gov

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

Interventions

DEVICE

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