Retropubic Hydrodissection and Trocar-induced Bladder Perforation During Retropubic Midurethral Slings
Recruiting now · Not applicable
Conditions studied: Bladder Perforation, Retropubic Midurethral Sling, Retropubic Hydrodissection
In brief
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
Key facts
- Study ID
- NCT07208682
- Run by
- University of Massachusetts, Worcester
- People needed
- 300
- Starts
- 2025-04-03
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-10-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- scheduled for retropubic midurethral sling
You may not qualify if…
- cognitive or intellectual impairment that would hinder ability to complete questionnaires or be consented
- having concurrent surgery for malignancy
Where it is running
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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