Phenazopyridine for Confirmation of Ureteral Patency

NCT ID: NCT02424149

Last Updated: 2016-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

Brief Summary

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In this prospective, randomized trial subjects will be randomized to receive phenazopyridine or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm ureteral patency intraoperatively.

Detailed Description

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Conditions

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Cystoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control

No preoperative phenazopyridine

Group Type NO_INTERVENTION

No interventions assigned to this group

Phenazopyridine

Preoperative phenazopyridine

Group Type EXPERIMENTAL

Phenazopyridine

Intervention Type DRUG

Interventions

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Phenazopyridine

Intervention Type DRUG

Other Intervention Names

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Pyridium

Eligibility Criteria

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Inclusion Criteria

* Females only
* Planned surgical procedure where cystoscopy will be used to document ureteral urine flow
* Age \> or = 18 years, no upper age limit
* Able and willing to consent

Exclusion Criteria

* Planned surgical procedure where cystoscopy will not be used
* Planned surgical procedure where cystoscopy is used for a purpose other than documenting ureteral urine flow
* age \<18 years
* pregnancy
* unable/unwilling to participate
* history of allergy or adverse reaction to phenazopyridine
* hepatic dysfunction
* known phenazopyridine hypersensitivity
* history of urologic surgery
* presence of ureteral stents prior to the planned surgical procedure
* concomitant suprapubic catheter placement
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

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Katie Propst

Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hartford Hospital

Hartford, Connecticut, United States

Site Status

Countries

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United States

References

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Propst K, Tunitsky-Bitton E, O'Sullivan DM, Steinberg AC, LaSala C. Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):348-355. doi: 10.1097/AOG.0000000000001472.

Reference Type DERIVED
PMID: 27399998 (View on PubMed)

Other Identifiers

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HHC-2015-0008

Identifier Type: -

Identifier Source: org_study_id