Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets
Condition: Ureteral Injury
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Recently, Indigo Carmine and Methylene Blue have been the standard agents to visualize
      ureteral jets during intraoperative cystoscopy. However, due to a national shortage of Indigo
      Carmine and Methylene Blue, there is a need to discover alternative IV and oral agents that
      are readily available and well tolerated when used for visualizing ureteral jets at the time
      of intraoperative cystoscopy. The aim of this study is to look at oral agents that have been
      studied such as pyridium (Phenazopyridine Hydrochloride) and riboflavin and compare them in a
      three-arm double-blinded randomized controlled pilot study using riboflavin, pyridium, and a
      placebo. The aim of the study is to provide evidence that both pyridium and riboflavin are
      effective and safe for staining urine to facilitate visualization of jets in evaluating
      ureteral patency at the time of intraoperative cystoscopy.
    

Detailed description: 
      This is a 3 arm, double- blinded, randomized, controlled pilot study to look at the ease of
      evaluating ureteral patency at the time of intraoperative cystoscopy and comparing effects
      and possible adverse effects of these two interventions compared to subjects receiving a
      placebo. The interventions will be blinded to the investigators and to the participants. The
      Clinical Research Institute in the Texas Tech Health Sciences Center will assist with
      randomization techniques for administering the agents to the subjects. The subjects will take
      the agents on the morning of surgery 1 hour (+/- 15 minutes) prior to the procedure.

      Group A will take 200 mg of oral Pyridium 1 hour before surgery. Group B will take 400 mg of
      riboflavin 1 hour before surgery. The placebo, 50 mg of vitamin B1 thiamine, will be
      administered to Group C patients. Group C will take the placebo (50 mg of thiamine) 1 hour
      before surgery. This study will be double blinded. There will be a third party who prepares
      an envelope for the patient. The patient will be unaware of which one it will be, but will
      have appropriate consent ahead of time. The physicians doing the case will be blinded to
      which agent was administered to the patient. A data collection sheet will be filled in by a
      member of the study team. Body Mass Index (BMI), height, weight, Liver Function Tests (LFTs),
      creatinine, and time from ingestion to time of cystoscopy will be recorded. Additionally, the
      surgeons will complete a survey regarding the stain of the urine and quality of the urine
      jet. The investigators will have the options of writing in no color, slightly colored, or
      bright colored urine and for the jet the investigators will have the options of trickle,
      moderate jet, or strong jet. These data will be collected and then entered into a database
      and analyzed for statistical significance. In this study, the investigators will define
      statistical significance as an alpha value of < 0.05 with respect to the riboflavin and
      pyridium study groups compared with the control group. The data collection sheet represents a
      semi-quantitative color and flow grading system.

      Randomization will occur just prior to surgery. A randomization list will be generated by the
      statisticians in the Clinical Research Institute (CRI). Randomization will be through a
      series of sealed envelopes containing equal numbers of Group A, Group B and Group C
      allocations. Following enrollment, the study coordinator will draw the next sequential
      numbered envelope and proceed according to group assignment. A master list will be kept of
      patient identification (ID) and randomization assignment by an independent third party.
    

Intervention name(s): Pyridium; Riboflavin; Thiamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): a urine discoloration agent; a urine discoloration agent; active placebo not known to cause urine discoloration
Other intervention name(s): Group A; Group B; Group C
Intervention MeSH terms: Riboflavin; Thiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a 3 arm randomized controlled double blinded study. The arms will all be studied in parallel to each other and compared in their effectiveness for evaluation for urine jets on cystoscopy.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic