Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07208682

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

Led by University of Massachusetts, Worcester · Updated on 2025-10-06

300

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for retropubic midurethral sling surgery
Not Eligible

You will not qualify if you...

  • Cognitive or intellectual impairment that would prevent completing questionnaires or consenting
  • Having concurrent surgery for malignancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States, 01605

Actively Recruiting

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Research Team

E

Emily Wu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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