Recruiting

Bladder InstillationDoes Bladder Instillation Reduce Time to Discharge After Sling Surgery

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02277288

Conditions

Stress Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Filled bladder arm

Study Details

Brief summary:

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.

Conditions

Stress Urinary Incontinence

Study ID

NCT02277288

Start date

Dec, 2011

Status verified date

Jul, 2018

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Female
2. Age 18 years or older
3. History of stress urinary incontinence
4. Scheduled for outpatient mid-urethral sling procedure, any approach

Exclusion Criteria:

1. Age less than 18 years
2. Pregnancy
3. Inability to give informed consent
4. History of urinary retention

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Emptied bladder arm

No instillation of fluid into bladder.

experimental: Filled bladder arm

Instilled bladder with fluid.

Interventions

Filled bladder arm

Bladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures.

Primary outcome measure

Time between surgery and discharge home [ Time Frame: 2 Days ]

Central Contacts and Locations

Central contacts

Jennifer Anger, MD, MPH

3103852992

Locations

Cedars-Sinai Medical Center

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Jennifer Anger, MD, MPH

310-385-2992

Principal Investigator:

Jennifer Anger, MD, MPH

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jul 18, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2018-07-18.