Ureteral InjuryNCT02757417
Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency
A study testing sodium fluorescein and phenazopyridine in people with Ureteral Injury, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ureteral Injury
- What is being tested?
- sodium fluorescein and phenazopyridine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2019
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Patients must be 18 years or older as well as willing and able to provide informed consent
- Patients undergoing a scheduled gynecologic procedure with cystoscopy
Who cannot join
- - Patients are younger than 18 years
- Patients are unable or unwilling to provide informed consent
- Patients with a history of an allergic reaction to sodium fluorescein or phenazopyridine
- Patients with a history of renal insufficiency
- Patients with a history of liver disease
- Patients with a history of sickle cell disease
- Patients with a history of glucose-6-phosphate dehydrogenase deficiency
- Patients with a history of chronic obstructive pulmonary disease or currently being treated for asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency
To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.
- Conditions
- Ureteral Injury
- Being tested
- sodium fluorescein, phenazopyridine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium fluoresceinDrug
phenazopyridineDrug
| Study group | Role | What they receive |
|---|---|---|
| Sodium Fluorescein | Active comparator | Patients will receive an intravenous dose of 0.25 mL of 10% (500 mg, 5 mL) sodium fluorescein at the time of cystoscope insertion, for a total dose of 25 mg. Cystoscopy will be performed in the standard fashion during the course of the operation. Receives: Drug: sodium fluorescein |
| oral phenazopyridine | Active comparator | Patients randomized to the phenazopyridine arm will be given a 200 mg pill with a sip of water in the pre-operative area 1 hour before their scheduled procedure. Cystoscopy will be performed in the standard fashion during the course of the operation. Receives: Drug: phenazopyridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups
Measured: 12 months
Secondary outcomes (1)
number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2018 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Study never started
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.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Megan Billow, Graham Chapman, Sangeeta Mahajan, Alex Soriano, Sherif El-Nashar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757417
- Sponsor's protocol ID
- UHcaseMC1
- Status last verified
- May 2022
- First submitted
- 27 Apr 2016
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency
- ClinicalTrials.gov ID
- NCT02757417
- Acronym / sponsor ID
- UHcaseMC1
- Conditions
- Ureteral Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Megan Billow, Graham Chapman, Sangeeta Mahajan, Alex Soriano, Sherif El-Nashar
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 May 2016 (estimated)
- 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.
To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Fluorescein | Active comparator | Drug: sodium fluoresceinPatients will receive an intravenous dose of 0.25 mL of 10% (500 mg, 5 mL) sodium fluorescein at the time of cystoscope insertion, for a total dose of 25 mg. Cystoscopy will be performed in the standard fashion during the course of the operation. |
| oral phenazopyridine | Active comparator | Drug: phenazopyridinePatients randomized to the phenazopyridine arm will be given a 200 mg pill with a sip of water in the pre-operative area 1 hour before their scheduled procedure. Cystoscopy will be performed in the standard fashion during the course of the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Patients must be 18 years or older as well as willing and able to provide informed consent
- Patients undergoing a scheduled gynecologic procedure with cystoscopy
Key exclusion criteria (8 listed)
- - Patients are younger than 18 years
- Patients are unable or unwilling to provide informed consent
- Patients with a history of an allergic reaction to sodium fluorescein or phenazopyridine
- Patients with a history of renal insufficiency
- Patients with a history of liver disease
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 |
|---|---|---|
| sodium fluorescein | Drug | Sodium Fluorescein |
| phenazopyridine | Drug | oral phenazopyridine |
Primary outcome
differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups
Time frame: 12 months
1 secondary outcome
number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium fluorescein and phenazopyridine in people with Ureteral Injury, run by University Hospitals Cleveland Medical 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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 6 May 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups (time frame: 12 months). 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 6 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.