Vaginal Prolapse Pessary Material Trial PVC vs Silicon (NCT06641804) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Vaginal Prolapse Pessary Material Trial PVC vs Silicon
140 participantsStarted 2024-10-15
Plain-language summary
The goal of this clinical trial is to determine the effect of vaginal ring pessary material on pessary complications and patients' satisfaction.
Participants who are using PVC (polyvinyl chloride) pessary will be randomized to
1. PVC vaginal ring pessary
2. Silicon vaginal ring pessary
Their pessary-related complications, patients' satisfaction, pain during pessary exchange and prolapse related symptoms with reference to PFDI-20 score will be assessed in a period of six months.
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
* At least 18 years old who understand written traditional Chinese
* Diagnosed with stage 1-4 POP according to the standard of Pelvic organ prolapse Quantification (POP-Q)
* Using PVC pessary as long term management for POP
* Willing to participate and provide a written informed consent.
Exclusion criteria
* Do not understand or comprehend written traditional Chinese
* Cannot provide written consent
* Vaginal complication requiring discontinuation of pessary use
* Unable to follow up clinic 6 months later
* Pregnant or lactating
* Recruited in other research studies
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.