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

NCT07208682 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-10-06

No results posted yet for this study

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

Conditions

  • Bladder Perforation
  • Retropubic Midurethral Sling
  • Retropubic Hydrodissection

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.

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2027-04-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07208682 on ClinicalTrials.gov