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Trial record 1 of 1 for:    NCT02277288
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Does Bladder Instillation Reduce Time to Discharge After Sling Surgery

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ClinicalTrials.gov Identifier: NCT02277288
Recruitment Status : Recruiting
First Posted : October 29, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer T. Anger, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Other: Filled bladder arm Not Applicable

Detailed Description:

Urinary stress incontinence affects 4-35% of women. Due to the large economic impact and prevalence of the disease, urinary incontinence is a significant public health issue. With rising healthcare costs it has become increasingly important to manage patient care in the most cost-efficient manner. Considering the increasing number of women undergoing mid-urethral sling procedures, it is imperative that perioperative care is streamlined in order to minimize cost. The Cedars-Sinai Center for Continence and Women's Pelvic Health instituted a new practice pattern that enables patients to complete a voiding trial sooner after surgery compared to previous practice patterns thus allowing patients to be discharged earlier and ultimately decreasing cost. The purpose of this study is to compare the previous voiding trial practice (emptying the bladder at the end of surgery) versus the newly instituted practice (filling with bladder with 250cc) and perform a cost benefit analysis to determine if there is a significant decrease in recovery and discharge time. Both of these practices fall under the standard-of-care. However, of the several standard-of-care procedures, none have been tested for superiority. To date there are no randomized control trials that address this issue in female mid-urethral sling surgery.

Boccola et al showed in a study of 60 men who had undergone transurethral resection of the prostate (TURP) that by instilling the bladder with 300-500cc of warm saline the time to void was significantly decreased compared to standard indwelling catheter removal. It was also shown that the bladder instillation group had a significantly shorter time to discharge. The study suggested that given the significant decrease in time in recovery, this would be an ideal practice for many other outpatient procedures. Willson, et al, in another randomized trial of 75 men who underwent TURP, found that bladder infusion allowed early decision-making for discharge on the second postoperative day. Finally, McAchran and Goldman found that when patients were managed using a fast-track regimen in the outpatient setting after mid-urethral sling procedures the median time from the recovery area to discharge was less than 3 hours.

For our study, if a significant decrease in the time to discharge with the newly instituted practice pattern is demonstrated, then this practice can be adopted by other institutions and become the new standard of care to help decrease both cost and patient time in the hospital.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Does Intraoperative Bladder Instillation Decrease Outpatient Recovery Time After Mid-Urethral Sling
Study Start Date : December 2011
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
No Intervention: Emptied bladder arm
No instillation of fluid into bladder.
Experimental: Filled bladder arm
Instilled bladder with fluid.
Other: Filled bladder arm
Bladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures.




Primary Outcome Measures :
  1. Time between surgery and discharge home [ Time Frame: 2 Days ]
    Will analyze if the time to discharge is shorter in those patients who have had bladder instillation versus those with an indwelling catheter postoperatively.


Secondary Outcome Measures :
  1. Hospital charges [ Time Frame: 1 Month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277288


Contacts
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Contact: Jennifer Anger, MD, MPH 3103852992

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Jennifer Anger, MD, MPH    310-385-2992      
Principal Investigator: Jennifer Anger, MD, MPH         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Jennifer Anger, MD, MPH Cedars-Sinai Medical Center

Publications:
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Responsible Party: Jennifer T. Anger, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02277288     History of Changes
Other Study ID Numbers: Pro00026292
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders