Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy (NCT07008898) | Clinical Trial Compass
RecruitingNot Applicable
Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
United States110 participantsStarted 2025-07-08
Plain-language summary
This study looks at the best time to place a midurethral sling (MUS), which is a small piece of mesh used to treat stress urinary incontinence (SUI) (leaking urine when you cough, laugh, or exercise). The sling is placed during a type of surgery called robotic sacrocolpopexy (RSC). This surgery helps fix pelvic organ prolapse, when organs like the bladder or uterus drop from their normal place.
Doctors can place the sling either before or after they lift and support the top of the vagina during surgery, but they aren't sure which timing works better. In this study, investigators are comparing what is the best time to place the sling, how the patient feels after surgery and if a patient's symptoms got better or worse.
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 of age
* Able to speak and read English and Spanish
* Diagnosis of pelvic organ prolapse stage 2-4
* Planning to undergo a robotic-assisted sacrocolpopexy
* Demonstrable SUI (either by CST, with or without prolapse reduction, or UDS) within the year prior to enrollment
* Planning to undergo concomitant SUI correction with MUS at the time of RSC
Exclusion Criteria:
* Less than 18 years of age
* Unable to speak and read English or Spanish
* No diagnosis of SUI (prophylactic slings)
* History of prior surgery for SUI
* Bladder capacity \<200 mL or post-void residual (PVR) \>150 mL
* Current genitourinary fistula or urethral diverticulum
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
1
Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative