Overview
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.
Description
Investigators will conduct a prospective, randomized, noninferiority trial on patients undergoing retropubic midurethral sling (RP MUS) placement at the time of robotic-assisted sacrocolpopexy (RSC).
Patients scheduled to undergo retropubic midurethral sling placement at the time of robotic- assisted sacrocolpopexy will be invited to participate during regularly scheduled preoperative visits with their urogynecologic provider. Participants will be randomized to receive RP MUS before RSC or after RSC. Randomization will be conducted in RedCap. Randomization will be performed using a variable permutated block randomization scheme. The Randomization window will be +/- 4 days before their scheduled surgery, and patients will be blinded to sequence of MUS placement intraoperatively.
Eligibility
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