Trial of Two Techniques to Assess Postoperative Voiding Function

NCT ID: NCT02150083

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

OR retrograde fill

Intervention Type: PROCEDURE

PACU 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 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OR retrograde fill

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Matthews, MD

Role: STUDY_DIRECTOR

University of North Carolina

Erinn Myers, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

11-1950

Identifier Type: -

Identifier Source: org_study_id