Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy

Overview

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.

Full Title of Study: “Randomized Controlled Trial Evaluating Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2018

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: furosemide
    • furosemide 10mg (1mL) IV push for one dose
  • Placebo Comparator: placebo
    • normal saline 1mL IV push for one dose

Clinical Trial Outcome Measures

Primary Measures

  • time to ureteral patency
    • Time Frame: intra-operative
    • time to confirmation of ureteral patency in seconds

Secondary Measures

  • adverse effects from furosemide administration
    • Time Frame: immediately post operative (1-3 days post operatively)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of South Florida
  • Provider of Information About this Clinical Study
    • Sponsor

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