Bladder Instillation for Urinary Incontinence
Trial Summary
What is the purpose of this trial?
The purpose of this randomized control trial study is to determine if intraoperative bladder instillation of fluid decreases the time to discharge after having an outpatient mid-urethral sling procedure, and to measure the cost savings of this decrease in hospital stay. Charges will be broken down between recovery room charges and discharge area, as recovery room charges are significantly higher. The investigators suspect that a shorter time in the recovery room will translate into fewer charges.
Will I have to stop taking my current medications?
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 data supports the effectiveness of the treatment Bladder Instillation for Urinary Incontinence?
Is bladder instillation generally safe for humans?
How does bladder instillation differ from other treatments for urinary incontinence?
Bladder instillation is unique because it involves directly introducing medication into the bladder, which can provide high drug concentration at the site with reduced systemic exposure. This method can be more effective and have fewer side effects compared to oral medications, as seen with treatments like intravesical oxybutynin, which is well-tolerated and minimizes side effects.210111213
Research Team
Jennifer Anger, MD, MPH
Principal Investigator
Cedars-Sinai Medical Center
Eligibility Criteria
This trial is for women aged 18 or older with stress urinary incontinence who are scheduled for an outpatient mid-urethral sling procedure. It's not suitable for those under 18, pregnant, unable to consent, or with a history of urinary retention.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Immediate Recovery
Participants undergo mid-urethral sling surgery and immediate postoperative recovery
Postoperative Monitoring
Participants are monitored for time to discharge and recovery efficiency
Follow-up
Participants are monitored for safety and effectiveness after discharge
Treatment Details
Interventions
- Filled bladder arm (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor