Viewing Study NCT00392210



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00392210
Status: COMPLETED
Last Update Posted: 2017-04-27
First Post: 2006-10-23

Brief Title: Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Sponsor: University of Rochester
Organization: University of Rochester

Study Overview

Official Title: Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Status: COMPLETED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 urogynecologic 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 patients 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 patients 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 23 the total volume voided volume residual the trial is considered passed and the catheter is removed If a patient voids 23 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None