Retropubic Hydrodissection for Bladder Rupture
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to reduce bladder injuries during a common surgery for stress urinary incontinence, which occurs when urine leaks during activities like coughing or exercising. The surgery involves placing a sling to support the bladder, but the tool used can sometimes accidentally puncture the bladder. The trial will test whether a special water injection (retropubic hydrodissection) can help prevent these injuries. Individuals scheduled for this sling surgery may be suitable candidates for the trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical outcomes for many.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that retropubic hydrodissection is safe for bladder rupture?
Research has shown that retropubic hydrodissection is generally well-tolerated. In past studies, 62% of patients underwent this technique without a significant reduction in the risk of bladder perforation. However, it did not cause any additional side effects. This suggests that the procedure is safe, even if it doesn't significantly lower the risk of perforation.
Overall, retropubic hydrodissection does not frequently cause severe side effects. While it may not prevent all complications, it has been used safely without major issues.12345Why are researchers excited about this trial?
Researchers are excited about retropubic hydrodissection for bladder rupture because it offers a novel approach to managing this condition. Unlike traditional methods, which often involve surgical repair or catheterization, this technique uses a 20-gauge spinal needle to inject 60cc of sterile saline into the retropubic space. This method could potentially minimize the invasiveness of treatment, reduce recovery times, and improve patient outcomes by targeting the specific area of injury with precision. By exploring this technique, researchers hope to find a less invasive and more effective way to treat bladder ruptures.
What evidence suggests that retropubic hydrodissection is effective for reducing trocar-induced bladder perforations?
This trial will compare retropubic hydrodissection with no hydrodissection to assess its effectiveness in preventing bladder injuries. Research has shown that retropubic hydrodissection, which involves injecting saltwater where surgical tools are used, does not effectively lower the risk of bladder injury. One study found that this method did not significantly reduce the chance of bladder injury during surgery. The findings suggest that other factors, like the surgeon's skill and technique, might be more important in preventing this issue. While hydrodissection is an option in this trial, strong evidence does not support its effectiveness in preventing bladder injuries during these surgeries.12567
Are You a Good Fit for This Trial?
This trial is for individuals undergoing retropubic midurethral sling surgery to treat stress urine incontinence. Participants must be suitable candidates for the procedure. Specific inclusion and exclusion criteria are not provided, but typically these would relate to general health status and specific medical conditions that could affect surgical outcomes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants fill out a baseline urinary symptom questionnaire (UDI-6) at a preoperative visit
Treatment
Participants undergo retropubic midurethral sling surgery with or without hydrodissection
Follow-up
Participants are monitored for secondary outcomes such as urinary symptoms, pain, and voiding trial results
What Are the Treatments Tested in This Trial?
Interventions
- Retropubic Hydrodissection
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor