Ureteral InjuryEarly Phase 1NCT03432572
Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets
A Early Phase 1 study testing Pyridium, Riboflavin and Thiamine in people with Ureteral Injury, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ureteral Injury
- What is being tested?
- Pyridium, Riboflavin and Thiamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2018to 30 Jun 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Pilot Study: Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets
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.
Read the 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.
- Conditions
- Ureteral Injury
- Being tested
- Pyridium, Riboflavin, Thiamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyridiumDrug
Also called Group A
a urine discoloration agent
RiboflavinDrug
Also called Group B
a urine discoloration agent
ThiamineDrug
Also called Group C
active placebo not known to cause urine discoloration
| Study group | Role | What they receive |
|---|---|---|
| pyridium | Experimental | 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. Receives: Drug: Pyridium |
| riboflavin | Active comparator | 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. Receives: Drug: Riboflavin |
| thiamine | Placebo comparator | 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. Receives: Drug: Thiamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine discoloration on cystoscopy
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start27 Jun 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cornelia DeRiese, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432572
- Sponsor's protocol ID
- L18-072
- Status last verified
- Aug 2020
- First submitted
- 1 Feb 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets
- ClinicalTrials.gov ID
- NCT03432572
- Acronym / sponsor ID
- L18-072
- Conditions
- Ureteral Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| pyridium | Experimental | Drug: PyridiumGroup 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. |
| riboflavin | Active comparator | Drug: RiboflavinGroup 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. |
| thiamine | Placebo comparator | Drug: ThiamineGroup 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyridiumAlso: Group Aa urine discoloration agent | Drug | pyridium |
| RiboflavinAlso: Group Ba urine discoloration agent | Drug | riboflavin |
| ThiamineAlso: Group Cactive placebo not known to cause urine discoloration | Drug | thiamine |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia DeRiese, MD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pyridium, Riboflavin and Thiamine in people with Ureteral Injury, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine discoloration on cystoscopy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.