Injecting saline to lower bladder puncture risk during retropubic midurethral sling surgery
Does Retropubic Hydrodissection Decrease Trocar-induced Bladder Perforation Rates During Placement of Retropubic Midurethral Slings? A Randomized Controlled Trial
This trial tests whether injecting sterile saline into the retropubic space during retropubic midurethral sling surgery can reduce the chance that the trocar will puncture the bladder for adult women having this procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT07208682 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial at UMass Memorial enrolling adult women scheduled for retropubic midurethral sling surgery who can complete English or Spanish questionnaires. At the preoperative visit participants complete a baseline urinary symptom survey (UDI-6) and on the day of surgery are randomized to receive standardized retropubic hydrodissection (60 mL saline given via a 20-gauge spinal needle, 30 mL on each side) or to no hydrodissection. The primary outcome is the rate of trocar-induced bladder perforation detected intraoperatively; secondary outcomes include postoperative urinary symptoms, pain, estimated blood loss, and voiding trial results. Subjects who are pregnant, have concurrent surgery for malignancy, or cannot complete consent/questionnaires are excluded.
Who should consider this trial
Good fit: Adult women fluent in English or Spanish who are scheduled for a retropubic midurethral sling and are able to provide consent and complete questionnaires are ideal candidates.
Not a fit: Patients who are pregnant, undergoing concurrent surgery for malignancy, have limited English or Spanish proficiency, or who are having a different type of sling surgery are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this technique could lower the rate of trocar-related bladder perforations and reduce operative time, bleeding, and postoperative urinary complications.
How similar studies have performed: Hydrodissection in this exact application has limited randomized data, and while similar infiltration techniques have been used in pelvic surgery, strong evidence that it reduces trocar-induced bladder perforation is lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Worcester, Massachusetts
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Emily Wu, MD
- Email: emily.wu@umassmemorial.org
- Phone: 508-334-9840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.