Clinical Trials Directory

Trials / Terminated

TerminatedNCT02739256

Early Versus Late Voiding Trials After Prolapse Repair

Normal Voiding Function After Surgical Repair of Pelvic Organ Prolapse: A Randomized Trial Comparing Day of Surgery Retrograde Void Trials to Standard Postoperative Day One Retrograde Void Trials

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
57 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
Female
Age
21 Years
Healthy volunteers
Not accepted

Summary

The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.

Detailed description

Overnight indwelling catheterization is a prevalent practice after surgical repair of pelvic organ prolapse. A voiding trial is performed postoperative day one to determine if urinary retention or abnormal bladder function exists. A significant number of patients ranging from 26-47% will require continued catheterization post-op for urinary retention in order to avoid injuries associated with over distention of the bladder and ureteral reflux. This study aims to explore a strategy to reduce the length of catheterization post-operatively by testing the bladder at a closer interval to surgery. An earlier voiding trial may improve patient perioperative satisfaction and decrease catheter associated urinary tract infections. Additional benefits that may also be seen are earlier first ambulation and quicker achievement of post-op discharge milestones (pain control, ambulation with symptoms, oral intake tolerance and completion of a voiding trial). To date, few studies have attempted a day of surgery voiding trial in patients being admitted for repair of pelvic organ prolapse that requires an overnight admission.

Conditions

Interventions

TypeNameDescription
PROCEDURERetrograde voiding trialA bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids.

Timeline

Start date
2016-02-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2016-04-15
Last updated
2018-06-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02739256. Inclusion in this directory is not an endorsement.