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Does Bladder Instillation Reduce Time to Discharge After Sling Surgery

Primary Purpose

Stress Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Filled bladder arm
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Emptied bladder arm

Filled bladder arm

Arm Description

No instillation of fluid into bladder.

Instilled bladder with fluid.

Outcomes

Primary Outcome Measures

Time between surgery and discharge home
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

Hospital charges

Full Information

First Posted
October 16, 2014
Last Updated
July 17, 2018
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02277288
Brief Title
Does Bladder Instillation Reduce Time to Discharge After Sling Surgery
Official Title
Does Intraoperative Bladder Instillation Decrease Outpatient Recovery Time After Mid-Urethral Sling
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Recruiting
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emptied bladder arm
Arm Type
No Intervention
Arm Description
No instillation of fluid into bladder.
Arm Title
Filled bladder arm
Arm Type
Experimental
Arm Description
Instilled bladder with fluid.
Intervention Type
Other
Intervention Name(s)
Filled bladder arm
Intervention Description
Bladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures.
Primary Outcome Measure Information:
Title
Time between surgery and discharge home
Description
Will analyze if the time to discharge is shorter in those patients who have had bladder instillation versus those with an indwelling catheter postoperatively.
Time Frame
2 Days
Secondary Outcome Measure Information:
Title
Hospital charges
Time Frame
1 Month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Age 18 years or older History of stress urinary incontinence Scheduled for outpatient mid-urethral sling procedure, any approach Exclusion Criteria: Age less than 18 years Pregnancy Inability to give informed consent History of urinary retention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Anger, MD, MPH
Phone
3103852992
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH
Phone
310-385-2992
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH

12. IPD Sharing Statement

Citations:
PubMed Identifier
21492377
Citation
Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.
Results Reference
background
PubMed Identifier
11119091
Citation
Wilson ID, Bramwell SP, Hollins GW. A randomized trial comparing bladder infusion with standard catheter removal after transurethral resection of the prostate. BJU Int. 2000 Dec;86(9):993-5. doi: 10.1046/j.1464-410x.2000.00963.x.
Results Reference
background
PubMed Identifier
19592077
Citation
McAchran SE, Goldman HB. Contemporary length of stay and resource utilization when using a fast-track regimen for mid-urethral sling surgery. Urology. 2009 Sep;74(3):531-4. doi: 10.1016/j.urology.2009.04.039. Epub 2009 Jul 9.
Results Reference
background
PubMed Identifier
16985863
Citation
Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.
Results Reference
background
PubMed Identifier
11530119
Citation
Wilson L, Brown JS, Shin GP, Luc KO, Subak LL. Annual direct cost of urinary incontinence. Obstet Gynecol. 2001 Sep;98(3):398-406. doi: 10.1016/s0029-7844(01)01464-8.
Results Reference
background

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Does Bladder Instillation Reduce Time to Discharge After Sling Surgery

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