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Using Phenazopyridine for In-office Cystoscopy

2016-03-23 07:08:23 | BioPortfolio

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.

Description

Eligible Participants will be randomized to either phenazopyridine 100 mg by mouth or no medication in a ratio of 1:1 using computer-generated block randomization. The statistician will create sequentially numbered opaque sealed envelopes to conceal group assignment.

Study Visit

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 100 mg by mouth approximately 60 minutes prior to the scheduled cystoscopy. Participants in both study arms will complete a short data collection form (See Data collection sheet 1). During the cystoscopy, at various time points, the time will be recorded. The primary outcome will be time to visualization of bilateral ureteral efflux from start of cystoscopy, which is defined as when the cystoscope enters the bladder (Data collection sheet 2). We will also collect total cystoscopy time and time to visualization of single ureteral efflux. The color of the efflux will also be documented (Data collection sheet 3).

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Cystoscopy

Intervention

Phenazopyridine

Status

Not yet recruiting

Source

Boston Urogynecology Associates

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-23T07:08:23-0400

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