RecruitingNot ApplicableNCT07208682

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

Does Retropubic Hydrodissection Decrease Trocar-induced Bladder Perforation Rates During Placement of Retropubic Midurethral Slings? A Randomized Controlled Trial


Sponsor

University of Massachusetts, Worcester

Enrollment

300 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

  • scheduled for retropubic midurethral sling

Exclusion Criteria2

  • cognitive or intellectual impairment that would hinder ability to complete questionnaires or be consented
  • having concurrent surgery for malignancy

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Interventions

PROCEDUREretropubic hydrodissection

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.


Locations(1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

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NCT07208682