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Trial of Two Techniques to Assess Postoperative Voiding Function

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OR retrograde fill
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Retention focused on measuring midurethral sling, voiding study, voiding trial, retrograde voiding trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • English-speaking
  • Women over the age of 18
  • Patients with stress urinary incontinence planning to undergo midurethral sling placement

Exclusion Criteria:

  • Prior incontinence surgery
  • Concomitant surgery for pelvic organ prolapse except for anterior repair
  • Intraoperative cystotomy
  • Patients taking anticholinergic medication

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OR retrograde fill

PACU retrograde fill

Arm Description

At completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is NOT replaced for the duration of the surgery. The surgery is completed and the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will be instructed to void. The voided volume and residual volume will be recorded.

At completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is replaced for the duration of the surgery and when complete the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will undergo a retrograde bladder fill with 300 mL of normal saline. The foley catheter will be removed and she will be instructed to void. The voided volume and residual volume will be recorded.

Outcomes

Primary Outcome Measures

Comparison of the proportion of subjects who passed the voiding trial between the two groups
Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit

Secondary Outcome Measures

Comparison of length of stay in post-anesthesia care unit between the two groups
Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit

Full Information

First Posted
May 23, 2014
Last Updated
May 28, 2014
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT02150083
Brief Title
Trial of Two Techniques to Assess Postoperative Voiding Function
Official Title
Diagnostic Accuracy of Two Techniques for Assessing Postoperative Voiding Function - A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many surgical procedures have been developed to treat SUI, and midurethral slings have gradually become the first line treatment. Voiding dysfunction, or inability for a patient to empty her bladder, immediately after surgery is common. A bladder test is often performed in the recovery area to see if the patient is able to empty her bladder. This typically consists of filling the bladder with 300 mL of saline through the foley catheter. The catheter is then removed and the patient is asked to void. The investigators then measure the voided volume and the residual left inside the bladder to determine if she is able to empty her bladder sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding trial that is initiated in the operating room. Our hypothesis was that a retrograde postoperative voiding trial initiated in the operating room would be as effective as a standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction while allowing for patients to spend less time in the recovery unit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
midurethral sling, voiding study, voiding trial, retrograde voiding trial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OR retrograde fill
Arm Type
Experimental
Arm Description
At completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is NOT replaced for the duration of the surgery. The surgery is completed and the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will be instructed to void. The voided volume and residual volume will be recorded.
Arm Title
PACU retrograde fill
Arm Type
No Intervention
Arm Description
At completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is replaced for the duration of the surgery and when complete the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will undergo a retrograde bladder fill with 300 mL of normal saline. The foley catheter will be removed and she will be instructed to void. The voided volume and residual volume will be recorded.
Intervention Type
Procedure
Intervention Name(s)
OR retrograde fill
Primary Outcome Measure Information:
Title
Comparison of the proportion of subjects who passed the voiding trial between the two groups
Description
Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit
Time Frame
Close of incision until discharge, approximately 3 hours.
Secondary Outcome Measure Information:
Title
Comparison of length of stay in post-anesthesia care unit between the two groups
Description
Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit
Time Frame
Close of incision until discharge, approximately 3 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English-speaking Women over the age of 18 Patients with stress urinary incontinence planning to undergo midurethral sling placement Exclusion Criteria: Prior incontinence surgery Concomitant surgery for pelvic organ prolapse except for anterior repair Intraoperative cystotomy Patients taking anticholinergic medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Matthews, MD
Organizational Affiliation
University of North Carolina
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erinn Myers, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Trial of Two Techniques to Assess Postoperative Voiding Function

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