Best timing for a midurethral sling during robotic pelvic organ prolapse repair
Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
This trial will test whether placing a midurethral sling before or after robotic sacrocolpopexy works better for women with stress urinary incontinence and pelvic organ prolapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT07008898 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, noninferiority trial comparing retropubic midurethral sling (RP MUS) placement before versus after robotic-assisted sacrocolpopexy (RSC). Eligible patients are randomized using a variable permuted block scheme via REDCap, with patient blinding to the sequence of sling placement intraoperatively. The trial measures patient symptoms, success rates, and complication rates following the two timing strategies. The goal is to determine whether one sequence yields equal or better continence and safety outcomes.
Who should consider this trial
Good fit: Women aged 18 or older with stage 2–4 pelvic organ prolapse, demonstrable stress urinary incontinence, planning robotic sacrocolpopexy with concomitant retropubic midurethral sling, and able to read English or Spanish.
Not a fit: Patients without demonstrable SUI, with prior SUI surgery, bladder capacity <200 mL or PVR >150 mL, current genitourinary fistula or urethral diverticulum, or who cannot read English/Spanish are not eligible and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the trial could identify the timing that reduces urine leakage and complications after prolapse repair, improving recovery and outcomes.
How similar studies have performed: Midurethral slings are well established for treating SUI, but randomized data specifically comparing sling placement before versus after robotic sacrocolpopexy are limited, making this sequencing question relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Albany Medical Center — Albany, New York, United States (Recruiting)
Study contacts
- Principal investigator: Gabriela E Halder, MD, MPH — University of Alabama at Birmingham
- Study coordinator: Martha K Coghlan, MD
- Email: mkcoghlan@uabmc.edu
- Phone: 6019883613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.