Actively Recruiting
Retropubic Hydrodissection and Trocar-induced Bladder Perforation During Retropubic Midurethral Slings
Led by University of Massachusetts, Worcester · Updated on 2025-10-06
300
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Retropubic midurethral slings are a common and effective treatment for stress urine incontinence. The trocar that is attached to the mesh material can hit the bladder which is called a perforation. While there are no known long-term adverse outcomes from trocar-induced bladder perforations, it can prolong operative time and bleeding. At academic institutions, it has been reported that trocar-induced perforations occurs in the range of 14-34% of the time. This study is a randomized controlled trial to see if an intervention can decrease trocar-induced bladder perforation rates. The primary outcome of this study is to measure trocar-induced bladder perforations in subjects undergoing a retropubic midurethral sling. Subjects would be randomized to either receive the hydrodissection in a standardized manner or to not receive it. Secondary outcomes include bothersome urinary symptoms, pain, estimated blood loss during surgery, and voiding trial results
CONDITIONS
Official Title
Retropubic Hydrodissection and Trocar-induced Bladder Perforation During Retropubic Midurethral Slings
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for retropubic midurethral sling surgery
You will not qualify if you...
- Cognitive or intellectual impairment that would prevent completing questionnaires or consenting
- Having concurrent surgery for malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
Actively Recruiting
Research Team
E
Emily Wu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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