Condition: Bladder Perforation · Retropubic Midurethral Sling · Retropubic Hydrodissection · Sponsor: University of Massachusetts, Worcester
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
This description comes directly from the study's public registry record.
Emily Wu, MD · 508-334-9840 · emily.wu@umassmemorial.org
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| University of Massachusetts Memorial Medical Center | Worcester, Massachusetts, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07208682