Best timing for a midurethral sling during robotic pelvic organ prolapse repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.