Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Voiding Trial
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- All women > 18 years of age presenting to the Division of Urogynecology at the University of Rochester Medical Center/Strong Memorial Hospital and undergoing gynecologic surgery which requires postoperative placement of a transurethral catheter.
- Subjects must be competent to give informed consent.
Exclusion Criteria:
- Any patient less than 18 years of age.
- Patients with suprapubic catheters postoperatively.
- Patients undergoing surgery that does not require transurethral catheterization postoperatively.
- Patients not competent to give informed consent.
- Patients who are pregnant.
- Patients undergoing procedures requiring prolonged bladder decompression (i.e. fistula repair).
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Spontaneous Fill
Retrograde Fill
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Who Passed Bladder Trial
Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).
Secondary Outcome Measures
Full Information
NCT ID
NCT00392210
First Posted
October 23, 2006
Last Updated
April 25, 2017
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT00392210
Brief Title
Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Official Title
Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
After gynecologic surgery, it may be difficult to void (urinate). This problem is usually short-term with normal function returning within a few days to a few weeks. For this reason, patients may require drainage of their bladder with a catheter immediately after surgery. Currently in our office, we use two different tests to see how well you are able to urinate and how quickly the catheter can be removed. The purpose of this study is to see which voiding test is better after gynecologic surgery.
Detailed Description
Postoperative voiding dysfunction is commonly encountered following gynecologic surgery. This dysfunction is usually short term, with normal function returning within a few days. Following uro/gynecologic surgery, most patients require drainage with either a transurethral or suprapubic catheter in the immediate postoperative period. Within our practice, we prefer drainage with a transurethral catheter.
At some point after surgery, the urethral catheter is removed and normal bladder function allowed to resume. At present, there is no generally accepted regimen to assess voiding efficiency. In our practice, we currently employ two regimens to both assess voiding efficiency and expedite catheter removal. In one technique, the catheter is removed and the patient's bladder is allowed to fill spontaneously. Patients are asked to void when they experience a strong urge. The voided volume is recorded and a post-void residual (PVR) is then measured by transurethral straight catheterization.
In the second technique, the patient's bladder is retrogradely filled with 300 cc of sterile fluid and the catheter removed. They are asked to void within 15 minutes of instillation and the voided volume is measured. The PVR is then obtained by transurethral straight catheterization.
In both cases, if the patient voids >2/3 the total volume (voided volume + residual) the trial is considered "passed" and the catheter is removed. If a patient voids < 2/3 of the total volume, the trial is considered "failed" and indicative of urinary retention. In this case the catheter replaced.
We aim to assess the ability of these techniques to accurately predict voiding efficiency and to determine if one technique is superior to the other.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spontaneous Fill
Arm Type
No Intervention
Arm Title
Retrograde Fill
Arm Type
Active Comparator
Intervention Type
Genetic
Intervention Name(s)
Voiding Trial
Intervention Description
Post-void residual and uroflow study will be done twice
Primary Outcome Measure Information:
Title
Number of Participants Who Passed Bladder Trial
Description
Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).
Time Frame
postoperatively after surgery on day1 or 2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All women > 18 years of age presenting to the Division of Urogynecology at the University of Rochester Medical Center/Strong Memorial Hospital and undergoing gynecologic surgery which requires postoperative placement of a transurethral catheter.
Subjects must be competent to give informed consent.
Exclusion Criteria:
Any patient less than 18 years of age.
Patients with suprapubic catheters postoperatively.
Patients undergoing surgery that does not require transurethral catheterization postoperatively.
Patients not competent to give informed consent.
Patients who are pregnant.
Patients undergoing procedures requiring prolonged bladder decompression (i.e. fistula repair).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K. Flynn, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
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