NCT07208682 Retropubic Hydrodissection and Trocar-induced Bladder Perforation During Retropubic Midurethral Slings
| NCT ID | NCT07208682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Massachusetts, Worcester |
| Condition | Bladder Perforation |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-03 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-04-03 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07208682 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Bladder Perforation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07208682 currently recruiting?
Yes, NCT07208682 is actively recruiting participants. Contact the research team at emily.wu@umassmemorial.org for enrollment information.
Where is the NCT07208682 trial being conducted?
This trial is being conducted at Worcester, United States.
Who is sponsoring the NCT07208682 clinical trial?
NCT07208682 is sponsored by University of Massachusetts, Worcester. The trial plans to enroll 300 participants.