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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Massachusetts, Worcester • ClinicalTrials.gov ID: NCT07208682

Registry updated: 2026-09-28
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Description

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

Interventions

  • retropubic hydrodissection (Procedure)
    subjects 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.

Eligibility criteria

Inclusion Criteria: * scheduled for retropubic midurethral sling Exclusion Criteria: * cognitive or intellectual impairment that would hinder ability to complete questionnaires or be consented * having concurrent surgery for malignancy

Conditions

Bladder Perforation Retropubic Midurethral Sling Retropubic Hydrodissection

Locations

  • University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record