Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy

NCT ID: NCT02960412

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Cystoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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furosemide

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

Group Type EXPERIMENTAL

furosemide

Intervention Type DRUG

10mg lasix given intraoperatively

placebo

normal saline 1mL IV push for one dose

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Normal saline given intraoperatively as placebo

Interventions

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furosemide

10mg lasix given intraoperatively

Intervention Type DRUG

Normal Saline

Normal saline given intraoperatively as placebo

Intervention Type DRUG

Other Intervention Names

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Lasix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30870291 (View on PubMed)

Other Identifiers

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Pro00026976

Identifier Type: -

Identifier Source: org_study_id

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