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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02150083
Other study ID # 11-1950
Secondary ID
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


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
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