300 Participants Needed

Retropubic Hydrodissection for Bladder Rupture

EW
Overseen ByEmily Wu, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I am scheduled for a specific surgical procedure to support my urethra.

Exclusion Criteria

I am able to understand and complete questionnaires.
I am undergoing surgery for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants fill out a baseline urinary symptom questionnaire (UDI-6) at a preoperative visit

1 visit

Treatment

Participants undergo retropubic midurethral sling surgery with or without hydrodissection

1 day

Follow-up

Participants are monitored for secondary outcomes such as urinary symptoms, pain, and voiding trial results

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Retropubic Hydrodissection
Trial Overview The study tests whether retropubic hydrodissection can reduce bladder perforations during sling surgery. It's a randomized controlled trial where participants are assigned by chance to either receive standardized hydrodissection or not, with the main goal of comparing bladder perforation rates between groups.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Retropubic hydrodissectionActive Control1 Intervention
Group II: No retropubic hydrodissectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35763669/
Risk Factors for Bladder Perforation at the Time of ...Retropubic hydrodissection was performed in 62% of the patients and was not associated with a lower risk of perforation (P = 0.86).
Objective Assessment of Rupture Parameters in Intact and ...Repeat rupture pressure (maximal bladder pressure achieved) and bladder compliance were noted to be significantly lower immediately post- ...
Home birth: as safe as in hospital?With good surgical and anaesthetic technique the risk of bladder perforation can indeed be very low, as Mr Smith points out; even where it ...
Objective Assessment of Rupture Parameters in Intact and ...The purpose of this study was to identify baseline data for pressure and volume when hydrodistention is attempted in explanted cadaveric bladders.
(PDF) A case of spontaneous bladder rupture successfully ...We present a case where we successfully treated bladder rupture employing a less invasive technique of transurethral debridement and hyperbaric ...
An Institutional Review of Bladder and Ureteric Injuries ...Conclusion: The incidence of bladder injury was 2.4%, and ureteric injury was 0.7%, with concurrent bladder and ureteric injury noted in 0.1%.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36585277/
Retrospective analysis of bladder perforation risk in ...The primary outcome was bladder perforation. Secondary outcomes were ICU admission, exploratory laparotomy, and VP shunt externalization, ...
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