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Using Phenazopyridine for In-office Cystoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715648
Recruitment Status : Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Eman Elkadry, M.D., Boston Urogynecology Associates

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE April 1, 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
Total cystoscopy time [ Time Frame: at time of cystoscopy ]
The total time of cystoscopy will be measured
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
Time to visualization of ureteral jets [ Time Frame: at time of cystoscopy ]
The time to visualization of the first ureteral jet will be recorded
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Phenazopyridine for In-office Cystoscopy
Official Title  ICMJE Using Phenazopyridine for In-office Cystoscopy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cystoscopy
  • Phenazopyridine
Intervention  ICMJE Drug: Phenazopyridine
Study Arms  ICMJE
  • 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
    Intervention: Drug: Phenazopyridine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2016)
94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02715648
Other Study ID Numbers  ICMJE 003-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eman Elkadry, M.D., Boston Urogynecology Associates
Study Sponsor  ICMJE Boston Urogynecology Associates
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eman Elkadry, MD Practitioner
PRS Account Boston Urogynecology Associates
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP