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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 below
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I am scheduled for a sling procedure to support my urethra.
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I am 18 years old or older.
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I am female.
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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 weeks
Treatment ~ Varies
Follow Up ~2 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days for reporting.

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
512 Previous Clinical Trials
163,114 Total Patients Enrolled
Jennifer Anger, MD, MPHPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Filled bladder arm Clinical Trial Eligibility Overview. Trial Name: NCT02277288 — N/A
Stress Incontinence Research Study Groups: Emptied bladder arm, Filled bladder arm
Stress Incontinence Clinical Trial 2023: Filled bladder arm Highlights & Side Effects. Trial Name: NCT02277288 — N/A
Filled bladder arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT02277288 — N/A
~18 spots leftby Dec 2025
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