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 range

18 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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