About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
scheduled for retropubic midurethral sling
Disqualifiers
cognitive or intellectual impairment that would hinder ability to complete questionnaires or be consented
having concurrent surgery for malignancy
Trial design
Parallel
Treatments tested in this trial
retropubic hydrodissection
Procedure/Surgerysubjects would receive retropubic hydrodissection prior to passage of the trocars. A total of 60cc of sterile injectable saline would be injected in the retropubic space with a 20g spinal needle along the anticipated path of the trocar.
Treatment groups
Trial outcomes
Primary outcomes
trocar-induced bladder perforation
the number of trocar-induced bladder perforations during one case would be measured
Sponsors and contacts
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