Using Phenazopyridine for In-office Cystoscopy

Cystoscopy Clinical Trial

Official title:

Using Phenazopyridine for In-office Cystoscopy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02715648
• Other study ID #: 003-2016
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2020
• Source: Boston Urogynecology Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystoscopy
• Phenazopyridine

Intervention

Drug:
• Phenazopyridine

Locations

Country	Name	City	State
United States	Boston Urogynecology Associates, 725 Concord Ave. Suite 1200	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cystoscopy time	The total time of cystoscopy will be measured	at time of cystoscopy
Secondary	Time to visualization of ureteral jets	The time to visualization of the first ureteral jet will be recorded	at time of cystoscopy