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

Conditions

• Bladder Perforation
• Retropubic Hydrodissection
• Retropubic Midurethral Sling

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• retropubic hydrodissection — PROCEDURE
  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.

Study Details

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

Key Dates

Start date

Apr 3, 2025

Status verified

Sep 2025

Primary completion

Apr 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Retropubic hydrodissection
  subjects would receive a total of 60cc sterile injectable saline in the retropubic space using a 20g spinal needle placed in the anticipated path of the trocars
• No Intervention: No retropubic hydrodissection
  this group would not receive retropubic hydrodissection

Primary Outcome Measure

trocar-induced bladder perforation [ Time Frame: during the surgery ]

Central Contacts

• Emily Wu, MD
  508-334-9840
  [email protected]

Locations (1)

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