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RECRUITING
NCT07208682
NA

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

Sponsor: University of Massachusetts, Worcester

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-04-03

Completion Date

2027-06

Last Updated

2025-10-06

Healthy Volunteers

Yes

Interventions

PROCEDURE

retropubic 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