Effect of Furosemide on Confirmation of Ureteral Patency... | NCT02960412

Studies
Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy

NCT02960412

Sponsor

University of South Florida

Status

Completed

Last Update Posted

Mar 28, 2019Actual

Enrollment

150Actual

Phase

Phase 4

Conditions

Cystoscopy

Interventions

furosemide
Normal Saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Mar 31, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Nov 7, 2016

First Submission Date that Met QC Criteria

Nov 8, 2016

First Posted Date

Nov 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2019

Last Update Posted Date

Mar 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
furosemide	Drug	10mg lasix given intraoperatively	furosemide	Lasix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to ureteral patency	time to confirmation of ureteral patency in seconds	intra-operative

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampa General Hospital		Tampa	Florida	33606	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30870291	Derived	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.

Type	Date	Date Unknown
Release	Apr 29, 2019
Reset	May 23, 2019

ID	Term
D005665	Furosemide
D000077330	Saline Solution

ID	Term
D013424	Sulfanilamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals