Trial of Two Techniques to Assess Postoperative Voiding Function

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150083
• Other study ID #: 11-1950
• Status: Completed
• Phase: N/A
• First received: May 23, 2014
• Last updated: May 28, 2014
• Start date: November 2011
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Procedure:
• OR retrograde fill

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the proportion of subjects who passed the voiding trial between the two groups	Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit	Close of incision until discharge, approximately 3 hours.	No
Secondary	Comparison of length of stay in post-anesthesia care unit between the two groups	Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit	Close of incision until discharge, approximately 3 hours	No