Skip to main content
OpenTrials
Completed

NCT Number: NCT02150083

Trial of Two Techniques to Assess Postoperative Voiding Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OR retrograde fill

Procedure

Primary outcomes

  1. Comparison of the proportion of subjects who passed the voiding trial between the two groups

    Time frame: Close of incision until discharge, approximately 3 hours.

    Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit

Secondary outcomes

  1. Comparison of length of stay in post-anesthesia care unit between the two groups

    Time frame: Close of incision until discharge, approximately 3 hours

    Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Diagnostic Accuracy of Two Techniques for Assessing Postoperative Voiding Function - A Randomized Trial

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 29, 2014
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.