Trial of Two Techniques to Assess Postoperative Voiding Function

NCT02150083 | Completed

• 1 other identifier: 11-1950
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Keywords

midurethral sling; voiding study; voiding trial; retrograde voiding trial

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

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

  Close of incision until discharge, approximately 3 hours

Study Arms (2)

OR retrograde fill

EXPERIMENTAL

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.

Procedure: OR retrograde fill

PACU retrograde fill

NO INTERVENTION

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 replaced for the duration of the surgery and when complete the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will undergo a retrograde bladder fill with 300 mL of normal saline. The foley catheter will be removed and she will be instructed to void. The voided volume and residual volume will be recorded.

Interventions

OR retrograde fill PROCEDURE

OR retrograde fill

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• Women over the age of 18
• Patients with stress urinary incontinence planning to undergo midurethral sling placement

You may not qualify if:

• Prior incontinence surgery
• Concomitant surgery for pelvic organ prolapse except for anterior repair
• Intraoperative cystotomy
• Patients taking anticholinergic medication

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Catherine Matthews, MD

  University of North Carolina

  STUDY DIRECTOR

• Erinn Myers, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 29, 2014
• Study Start: November 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

US (1)