Using Phenazopyridine for In-office Cystoscopy | NCT02715648

Studies
Using Phenazopyridine for In-office Cystoscopy

NCT02715648

Sponsor

Boston Urogynecology Associates

Status

Unknown status

Last Update Posted

Dec 31, 2020Actual

Enrollment

94Estimated

Phase

Not Applicable

Conditions

Cystoscopy
Phenazopyridine

Interventions

Phenazopyridine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Jun 1, 2021Estimated

First Submitted Date

Mar 17, 2016

First Submission Date that Met QC Criteria

Mar 21, 2016

First Posted Date

Mar 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2020

Last Update Posted Date

Dec 31, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Boston Urogynecology AssociatesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Phenazopyridine before cystoscopy	No Intervention	This group will not receive phenazopyridine prior to cystoscopy
Phenazopyridine before cystoscopy	Experimental	This group will receive 200mg of phenazopyridine prior to cystoscopy	Drug: Phenazopyridine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phenazopyridine	Drug		Phenazopyridine before cystoscopy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eman Elkadry, MD	Practitioner	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Urogynecology Associates, 725 Concord Ave. Suite 1200		Cambridge	Massachusetts	02138	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010621	Phenazopyridine

Ancestor Terms

ID	Term
D000631	Aminopyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

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