Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
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|ClinicalTrials.gov Identifier: NCT00392210|
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Genetic: Voiding Trial||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
|No Intervention: Spontaneous Fill|
|Active Comparator: Retrograde Fill||
Genetic: Voiding Trial
Post-void residual and uroflow study will be done twice
- Number of Participants Who Passed Bladder Trial [ Time Frame: postoperatively after surgery on day1 or 2 ]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).
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): NCT00392210
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Michael K. Flynn, MD||University of Rochester|