Actively Recruiting
Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
Led by University of Alabama at Birmingham · Updated on 2026-02-17
110
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the best timing for placing a midurethral sling (MUS), a small mesh used to treat stress urinary incontinence (SUI), during robotic sacrocolpopexy (RSC) surgery. RSC is a procedure that helps fix pelvic organ prolapse, where organs like the bladder or uterus descend from their normal position. The study aims to compare placing the sling either before or after lifting and supporting the vaginal apex during surgery, focusing on patient symptoms and satisfaction. Participants will undergo robotic-assisted sacrocolpopexy along with retropubic midurethral sling placement. They will be randomly assigned to have the sling placed either before or after the vaginal suspension during surgery. Randomization occurs within four days before surgery, and patients will not know the timing of their sling placement during the operation. During the study, participants will be assessed before and after surgery through various measures including the Urinary Distress Index at three months, stress tests at six weeks, and questionnaires on pelvic organ prolapse and incontinence symptoms. Researchers will also monitor surgical details, complications, need for retreatment, and patient satisfaction. Follow-up visits and evaluations will occur at six weeks and three months after surgery to thoroughly evaluate outcomes.
CONDITIONS
Brief Title
Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Able to speak and read English or Spanish
- Diagnosis of pelvic organ prolapse stage 2 to 4
- Planning to undergo robotic-assisted sacrocolpopexy
- Demonstrable stress urinary incontinence within the past year
- Planning to have midurethral sling placement at the time of robotic sacrocolpopexy
You will not qualify if you...
- Under 18 years of age
- Unable to speak or read English or Spanish
- No diagnosis of stress urinary incontinence (prophylactic sling)
- History of prior surgery for stress urinary incontinence
- Bladder capacity less than 200 mL or post-void residual over 150 mL
- Current genitourinary fistula or urethral diverticulum
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during preoperative urogynecologic provider visit
Duration - Single surgical procedure day
Participants undergo robotic-assisted sacrocolpopexy with midurethral sling placement either before or after the sacrocolpopexy procedure as randomized.
1 surgical visit (in-person)
Duration - Up to 3 months postoperative
Participants are monitored for surgical outcomes, complications, and patient satisfaction after the procedure.
Visits at 6 weeks and 3 months postoperative (in-person)
Trial Site Locations
Total: 2 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
Research Team
M
Martha K Coghlan, MD
G
Gabriela E Halder, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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