CompletedNot Applicable

Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse

Ukraine51 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in Pelvic Floor Distress Inventory-20 Score at 3 Months

Timeframe: Baseline and 3 months

Trial details

NCT IDNCT07554651

SponsorDnipro State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials