Using Phenazopyridine for In-office Cystoscopy

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.

Study Overview

• Status: Unknown
• Conditions: Cystoscopy; Phenazopyridine
• Intervention / Treatment: Drug: Phenazopyridine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Boston Urogynecology Associates, 725 Concord Ave. Suite 1200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: No Phenazopyridine before cystoscopy; This group will not receive phenazopyridine prior to cystoscopy
EXPERIMENTAL: Phenazopyridine before cystoscopy; This group will receive 200mg of phenazopyridine prior to cystoscopy	Drug: Phenazopyridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cystoscopy time	The total time of cystoscopy will be measured	at time of cystoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to visualization of ureteral jets	The time to visualization of the first ureteral jet will be recorded	at time of cystoscopy

Collaborators and Investigators

• Sponsor: Boston Urogynecology Associates
• Investigators: Principal Investigator: Eman Elkadry, MD, Practitioner

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (ESTIMATE): March 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 003-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO