Phase 4
N=130
Evaluation of Ureteral Patency in the Post-indigo Carmine Era
Ureteral Patency
Bottom Line
View on ClinicalTrials.gov: NCT02677623 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Visual Analog Scale (VAS) — 48; 20; 0; 28 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pyridium (Drug); Sodium Fluorescein (Drug); Mannitol (Drug); Normal Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) |
48; 20; 0; 28 | — |
Summary
Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to identify the opening of the ureters to ensure that they are working correctly. Historically, indigo carmine, an intravenous medication that dyes the urine blue, has been used to help visualize the opening of the ureters with cystoscopy which is a camera placed inside the bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus, investigators need to evaluate other methods for assessing ureteral patency. Ideal alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are readily available and are easy to use.
Examples of such agents currently being used to evaluate the ureters, include oral pyridium, IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by either dyeing the urine a different color such as pyridium and sodium fluorescein, or by having a different viscosity to urine such as mannitol. This study will compare three methods of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium fluorescein, and pyridium.
Eligibility Criteria
Inclusion Criteria
- Planned cystoscopy
Exclusion Criteria
- Women who are pregnant
- Women with contraindications to pyridium, sodium fluorescein or mannitol:
- Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
- Anuria
- Women with creatinine greater than 1 or Cr Cl < 50ml/minute
- Known allergy to pyridium, sodium fluorescein or mannitol.
- Women with a known urologic anatomical anomaly
Data sourced from ClinicalTrials.gov (NCT02677623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.