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NCT07208682From ClinicalTrials.govRecruiting

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

  • Bladder Perforation
  • Retropubic Midurethral Sling
  • Retropubic Hydrodissection

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
University of Massachusetts, Worcester
Enrolment target
300
Started
3 April 2025
Main results due
April 2027
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Women only.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(1)

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07208682. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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