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Using Phenazopyridine for In-office Cystoscopy

NCT ID: NCT02715648

Last Updated: 2020-12-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2021-06-01

Brief Summary

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The investigators propose to conduct a randomized controlled trial to evaluate whether administration of phenazopyridine prior to the procedure decreases office cystoscopy time. Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.

Detailed Description

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All potentially eligible participants will have had a complete history, physical examination, urinalysis and urine culture for clinical purposes. After eligibility is confirmed and written, informed consent is obtained, participants will be randomized to one of the two study arms. Participants randomized to phenazopyridine arm will receive 200 mg by mouth approximately 60 minutes prior to the scheduled cystoscopy. During the cystoscopy, at various time points, the time will be recorded.The color of the efflux will also be documented.

Conditions

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Cystoscopy Phenazopyridine

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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No Phenazopyridine before cystoscopy

This group will not receive phenazopyridine prior to cystoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

Phenazopyridine before cystoscopy

This group will receive 200mg of phenazopyridine prior to cystoscopy

Group Type EXPERIMENTAL

Phenazopyridine

Intervention Type DRUG

Interventions

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Phenazopyridine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patients undergoing in-office diagnostic cystoscopy at Boston Urogynecology Associates

Exclusion Criteria

* Women who have taken vitamin B the day of the cystoscopy
* Cystoscopy with concurrent treatments such as botulinum toxin or periurethral bulking injections
* Allergy to phenazopyridine
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Urogynecology Associates

OTHER

Sponsor Role lead

Responsible Party

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Eman Elkadry, M.D.

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Elkadry, MD

Role: PRINCIPAL_INVESTIGATOR

Practitioner

Locations

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Boston Urogynecology Associates, 725 Concord Ave. Suite 1200

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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003-2016

Identifier Type: -

Identifier Source: org_study_id