Vaginal Orthosis Use After Vaginal Reconstructive Surgery (NCT05812859) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Vaginal Orthosis Use After Vaginal Reconstructive Surgery
United States30 participantsStarted 2024-01-29
Plain-language summary
A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.
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
. POP-Q stage 2 to 4 pelvic organ prolapse
. Vaginal bulge symptoms as indicated by an affirmative response to either question 4 or 5 of the PFDI:
. Do you usually have a sensation of bulging or protrusion from the vaginal area?
. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
. Undergoing reconstructive vaginal surgery for POP-Q stage 2 to 4 pelvic organ prolapse that must include anterior compartment repair and apical suspension.
. Willing and able to use and self-manage novel vaginal orthosis after POP surgery from 2 weeks post-operative to 12 weeks post-operative.
. Available for 2 and 6 weeks, 3, 6, and 12 months follow-up.
. Able to complete study assessments, per clinician judgement.
Exclusion criteria
. Contraindication to surgical intervention as planned in the opinion of the treating surgeon (ie undergoing obliterative procedure).
. History of previous vaginal reconstructive surgery with or without hysterectomy for POP.
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.