Using Phenazopyridine for In-office Cystoscopy

Sponsor

Boston Urogynecology Associates (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02715648

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Total cystoscopy time [at time of cystoscopy]
The total time of cystoscopy will be measured

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Urogynecology Associates, 725 Concord Ave. Suite 1200	Cambridge	Massachusetts	United States	02138

Sponsors and Collaborators

Boston Urogynecology Associates

Investigators

Principal Investigator: Eman Elkadry, MD, Practitioner

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Elkadry, M.D., Principle Investigator, Boston Urogynecology Associates

ClinicalTrials.gov Identifier:

NCT02715648

Other Study ID Numbers:

003-2016

First Posted:

Mar 22, 2016

Last Update Posted:

Dec 31, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Dec 31, 2020