Recruiting

Hydrodissection

Sponsor:

University of Massachusetts, Worcester

Code:

NCT07208682

Conditions

Bladder Perforation

Retropubic Midurethral Sling

Retropubic Hydrodissection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

retropubic hydrodissection

Study Details

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

Conditions

Bladder Perforation

Retropubic Midurethral Sling

Retropubic Hydrodissection

Study ID

NCT07208682

Start date

Apr 3, 2025

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Massachusetts Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Oct 6, 2025

Last verified

Sep, 2025

Keywords

  • bladder perforation
  • retropubic midurethral sling
  • retropubic hydrodissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2025-10-06.