Trial of Two Techniques to Assess Postoperative Voiding Function

Not Applicable

Completed

• Conditions: Urinary Retention
• Interventions: Procedure: OR retrograde fill

• Registration Number: NCT02150083
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-28
• Last Update Submitted: 2014-05-28
• Study First Posted: 2014-05-29
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OR retrograde fill	OR retrograde fill	At completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is NOT replaced for the duration of the surgery. The surgery is completed and the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will be instructed to void. The voided volume and residual volume will be recorded.

Primary Outcome Measures

Name	Time	Method
Comparison of the proportion of subjects who passed the voiding trial between the two groups	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 Outcome Measures

Name	Time	Method
Comparison of length of stay in post-anesthesia care unit between the two groups	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

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States