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Bladder Instillation for Urinary Incontinence
N/A
Recruiting
Led By Jennifer Anger, MD, MPH
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled for outpatient mid-urethral sling procedure, any approach
Age 18 years or older
Must not have
History of urinary retention
Inability to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights
No Placebo-Only Group
Summary
This 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.
Who is the study for?
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.
What is being tested?
The study is testing if filling the bladder with fluid during surgery can shorten hospital stay after sling surgery for urinary incontinence. The cost impact due to reduced time spent in recovery will also be assessed.
What are the potential side effects?
While specific side effects aren't listed, typical risks may include discomfort from the bladder instillation process and potential complications related to standard surgical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a sling procedure to support my urethra.
Select...
I am 18 years old or older.
Select...
I am female.
Select...
I have had issues with urine leakage when coughing or exercising.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had problems with not being able to empty my bladder fully.
Select...
I am unable to understand and give consent for treatment.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time between surgery and discharge home
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Filled bladder armExperimental Treatment1 Intervention
Instilled bladder with fluid.
Group II: Emptied bladder armActive Control1 Intervention
No instillation of fluid into bladder.
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
513 Previous Clinical Trials
163,139 Total Patients Enrolled
Jennifer Anger, MD, MPHPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a sling procedure to support my urethra.I have had problems with not being able to empty my bladder fully.I am 18 years old or older.I am unable to understand and give consent for treatment.I am female.I have had issues with urine leakage when coughing or exercising.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Emptied bladder arm
- Group 2: Filled bladder arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.