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Using Phenazopyridine for In-office Cystoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02715648
Recruitment Status : Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : January 21, 2020
Information provided by (Responsible Party):
Eman Elkadry, M.D., Boston Urogynecology Associates

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystoscopy Phenazopyridine Drug: Phenazopyridine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Using Phenazopyridine for In-office Cystoscopy
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Total cystoscopy time [ Time Frame: at time of cystoscopy ]
    The total time of cystoscopy will be measured

Secondary Outcome Measures :
  1. Time to visualization of ureteral jets [ Time Frame: at time of cystoscopy ]
    The time to visualization of the first ureteral jet will be recorded

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02715648

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United States, Massachusetts
Boston Urogynecology Associates, 725 Concord Ave. Suite 1200
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Boston Urogynecology Associates
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Principal Investigator: Eman Elkadry, MD Practitioner
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Responsible Party: Eman Elkadry, M.D., Principle Investigator, Boston Urogynecology Associates Identifier: NCT02715648    
Other Study ID Numbers: 003-2016
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No