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NCT02960412 Clinical Trial

Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy

Cystoscopy Clinical Trial

Official title:
Randomized Controlled Trial Evaluating Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02960412
Other study ID # Pro00026976
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 1, 2017
Est. completion date June 30, 2018

Study information
Verified date March 2019
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates if administration of IV furosemide leads to expedited confirmation of ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after urogynecologic surgery.

Description:

Cystoscopy is performed routinely after urogynecologic surgery to ensure there was no injury to the urinary tract (urethra, bladder, or ureters). In order to confirm that no damage occurred to the ureters, a jet of urine must be visualized from each ureteral opening.

The time it takes to confirm this ureteral patency is variable and some sources suggest using furosemide to decrease the time it takes to see these jets. This study will evaluate what effect, if any, this medicine has on time to confirming ureteral patency.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date June 30, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Undergoing any urogynecologic surgery

- No allergy or contraindication to receiving furosemide

- Normal Creatinine/glomerular filtration rate

Exclusion Criteria:

- Unable to consent, including if non English speaking

- Allergy or contraindication to receiving furosemide

- Intraoperative injury to the lower urinary tract

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• furosemide
10mg lasix given intraoperatively
• Normal Saline
Normal saline given intraoperatively as placebo

Locations
Country Name City State
United States Tampa General Hospital Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to ureteral patency time to confirmation of ureteral patency in seconds intra-operative
Secondary adverse effects from furosemide administration immediately post operative (1-3 days post operatively)
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