NCT02960412

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

November 7, 2016

Last Update Submit

March 26, 2019

Conditions

Cystoscopy

Outcome Measures

Primary Outcomes (1)

  • time to ureteral patency

    time to confirmation of ureteral patency in seconds

    intra-operative

Secondary Outcomes (1)

  • adverse effects from furosemide administration

    immediately post operative (1-3 days post operatively)

Study Arms (2)

furosemide

EXPERIMENTAL

furosemide 10mg (1mL) IV push for one dose

Drug: furosemide

placebo

PLACEBO COMPARATOR

normal saline 1mL IV push for one dose

Drug: Normal Saline

Interventions

furosemideDRUG

10mg lasix given intraoperatively

Also known as: Lasix
furosemide
Normal SalineDRUG

Normal saline given intraoperatively as placebo

placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing any urogynecologic surgery
  • No allergy or contraindication to receiving furosemide
  • Normal Creatinine/glomerular filtration rate

You may not qualify if:

  • Unable to consent, including if non English speaking
  • Allergy or contraindication to receiving furosemide
  • Intraoperative injury to the lower urinary tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (1)

  • Patton S, Tanner JP, Prieto I, Jackson E, Greene K, Bassaly R, Wyman AM. Furosemide Use and Time to Confirmation of Ureteral Patency During Intraoperative Cystoscopy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Apr;133(4):669-674. doi: 10.1097/AOG.0000000000003155.

    PMID: 30870291DERIVED

MeSH Terms

Interventions

FurosemideSaline Solution

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

May 1, 2017

Primary Completion

March 31, 2018

Study Completion

June 30, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)