Clinical Trial

Retropubic Hydrodissection and Trocar-induced Bladder Perforation During Retropubic Midurethral Slings

Recruiting
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Summary
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
Trial Details
NCT Number NCT07208682
Lead Sponsor University of Massachusetts, Worcester
Conditions Bladder Perforation, Retropubic Midurethral Sling, Retropubic Hydrodissection
Enrollment 300 participants
Start Date 2025-04-03
Primary Completion 2027-04 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-10-06