Injecting saline to lower bladder puncture risk during retropubic midurethral sling surgery
Official title: Does Retropubic Hydrodissection Decrease Trocar-induced Bladder Perforation Rates During Placement of Retropubic Midurethral Slings? A Randomized Controlled Trial
Run by University of Massachusetts, Worcester · NCT07208682 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | April 2027 |
| Study ends | June 2027 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07208682 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cardiac Arrest: Using Ultrasound to Find Hidden Blood Flow
This study tests whether patients who have out-of-hospital cardiac arrest but no pulse still show some blood flow on ultrasound and whether that finding relates to survival.
-
Neighborhood Connect: improving Worcester neighborhoods through community action
Neighborhood Connect tests a community-led approach to make Worcester neighborhoods more attractive, safer, and livable by training residents and collaborating with local health officials.
-
Medically tailored groceries to help depression in people with food insecurity
This trial tests whether giving medically tailored groceries for six months can reduce depressive symptoms in adults who have depression and struggle with access to food.
-
Helping rural jails use medications for opioid use disorder better
This project tests a training program to help jail staff in rural areas start or expand medications for opioid use disorder and see if it improves public health outcomes.
-
Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) for re-entry
This trial tests a multicomponent program called MISSION-CJ with Peer Linkage Support to help adults released from two Massachusetts jails who have both mental health and substance use disorders.
-
Lifestyle change program with GLP-1 medication users
This trial tests whether the Noom digital lifestyle program helps adults on GLP-1 medications improve eating, activity, and weight-related health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.