- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03432572
Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets
Pilot Study: Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
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Texas
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Lubbock, Texas, United States, 79430
- Texas Tech University Health Sciences Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 21 to 75 years.
- Female patients ages who are scheduled to undergo gynecologic procedures where cystoscopy/need to determine ureteral patency may be indicated.
- Being seen in the department of Texas Tech OB/GYN.
- Willing to be randomized.
- Have not taken, or willing to stop taking pyridium or riboflavin at least 7 days prior to surgery.
Exclusion Criteria:
- Female patients who are found to have one of the following conditions based on their medical history: Active Inflammation of the Liver, Glomerulonephritis, Uremia, Kidney Disease, Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency, Anemia from Pyruvate Kinase and G6PD Deficiency.
- Patients who have allergies to pyridium, riboflavin, or vitamin B1 riboflavin.
- Patients who, for whatever reason, did not receive the product they were randomized to receive.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pyridium
Group A will take 200 mg of oral Pyridium 1 hour before surgery and then the urine jets will be evaluated on cystoscopy in the operating room during a gynecological procedure.
|
a urine discoloration agent
Other Names:
|
Active Comparator: riboflavin
Group B will take 400 mg of riboflavin 1 hour before surgery and then the urine jets will be evaluated on cystoscopy in the operating room during a gynecological procedure.
|
a urine discoloration agent
Other Names:
|
Placebo Comparator: thiamine
Group C will take the placebo (50 mg of thiamine) 1 hour before surgery and then the urine jets will be evaluated on cystoscopy in the operating room during a gynecological procedure.
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active placebo not known to cause urine discoloration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
urine discoloration on cystoscopy
Time Frame: through study completion, an average of 1 year
|
To determine if oral pyridium and vitamin B riboflavin administration prior to gynecologic procedures are effective and safe alternatives for evaluating ureteral patency at the time of cystoscopy.
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through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cornelia DeRiese, MD, Texas Tech University Health Sciences Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L18-072
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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