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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time between surgery and discharge home

Secondary outcome measures

Hospital charges

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,607 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment offer enrollment opportunities to individuals?

"As per clinicaltrials.gov, this research endeavour is actively enrolling participants. It was first made available on December 1st 2011 and the latest update came through on July 17th 2018."

Answered by AI

How many individuals have volunteered for this medical experiment?

"Right. According to the particulars hosted on clinicaltrials.gov, this medical experiment has been accepting patients since December 1st 2011 and was last edited on July 17th 2018. Currently, it is looking for 250 individuals from one single site."

Answered by AI

Recent research and studies

BJU InternationalJournal

The Infusion Method Trial of Void Vs Standard Catheter Removal in the Outpatient Setting: A Prospective Randomized Trial

Boccola, Mark A., Anant Sharma, Claire Taylor, Lih-Ming Wong, Douglas Travis, and Steven Chan. 2011. “The Infusion Method Trial of Void Vs Standard Catheter Removal in the Outpatient Setting: A Prospective Randomized Trial”. BJU International. Wiley. doi:10.1111/j.1464-410x.2011.10044.x.

European Journal of Obstetrics & Gynecology and Reproductive BiologyJournal

Risk Factors for the Development of Stress Urinary Incontinence During Pregnancy in Primigravidae: A Review of the Literature

Sangsawang, Bussara. 2014. “Risk Factors for the Development of Stress Urinary Incontinence During Pregnancy in Primigravidae: A Review of the Literature”. European Journal of Obstetrics & Gynecology and Reproductive Biology. Elsevier BV. doi:10.1016/j.ejogrb.2014.04.010.

UrologyJournal

Contemporary Length of Stay and Resource Utilization When Using a Fast-track Regimen for Mid-urethral Sling Surgery

McAchran, Sarah E., and Howard B. Goldman. 2009. “Contemporary Length of Stay and Resource Utilization When Using a Fast-track Regimen for Mid-urethral Sling Surgery”. Urology. Elsevier BV. doi:10.1016/j.urology.2009.04.039.

Obstetrics & GynecologyJournal