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Trial of Two Techniques to Assess Postoperative Voiding Function

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02150083
Enrollment
59
Registered
2014-05-29
Start date
2011-11-30
Completion date
2014-04-30
Last updated
2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention

Keywords

midurethral sling, voiding study, voiding trial, retrograde voiding trial

Brief 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.

Interventions

PROCEDUREOR retrograde fill

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the proportion of subjects who passed the voiding trial between the two groupsClose 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

MeasureTime frameDescription
Comparison of length of stay in post-anesthesia care unit between the two groupsClose of incision until discharge, approximately 3 hoursGroup 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026