NCT02715648

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

5.2 years

First QC Date

March 17, 2016

Last Update Submit

December 30, 2020

Conditions

CystoscopyPhenazopyridine

Outcome Measures

Primary Outcomes (1)

  • Total cystoscopy time

    The total time of cystoscopy will be measured

    at time of cystoscopy

Secondary Outcomes (1)

  • Time to visualization of ureteral jets

    at time of cystoscopy

Study Arms (2)

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

PhenazopyridineDRUG
Phenazopyridine before cystoscopy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients undergoing in-office diagnostic cystoscopy at Boston Urogynecology Associates

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Urogynecology Associates, 725 Concord Ave. Suite 1200

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Interventions

Phenazopyridine

Intervention Hierarchy (Ancestors)

AminopyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eman Elkadry, MD

    Practitioner

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 22, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

December 31, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)