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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Massachusetts, Worcester

About this trial

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

This trial accepts healthy volunteers

Qualifiers

scheduled for retropubic midurethral sling

Disqualifiers

cognitive or intellectual impairment that would hinder ability to complete questionnaires or be consented

having concurrent surgery for malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • retropubic hydrodissection

    Procedure/Surgery

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Retropubic hydrodissectionActive comparator 1 intervention
Group B: No retropubic hydrodissectionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

trocar-induced bladder perforation

the number of trocar-induced bladder perforations during one case would be measured

Time frame
during the surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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