Using Phenazopyridine for In-office Cystoscopy

Not Applicable

• Conditions: Cystoscopy; Phenazopyridine
• Interventions: Drug: Phenazopyridine

• Registration Number: NCT02715648
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-22
• Study Start: 2016-04-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2020-12-31
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenazopyridine before cystoscopy	Phenazopyridine	This group will receive 200mg of phenazopyridine prior to cystoscopy

Primary Outcome Measures

Name	Time	Method
Total cystoscopy time	at time of cystoscopy	The total time of cystoscopy will be measured

Secondary Outcome Measures

Name	Time	Method
Time to visualization of ureteral jets	at time of cystoscopy	The time to visualization of the first ureteral jet will be recorded

Trial Locations

Locations (1)

Boston Urogynecology Associates, 725 Concord Ave. Suite 1200; 🇺🇸 Cambridge, Massachusetts, United States