Evaluation of Ureteral Patency in the Post-indigo Carmine Era

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Mannitol

Criteria

Inclusion Criteria:

• Planned cystoscopy

Exclusion Criteria:

1. Women who are pregnant

2. Women with contraindications to pyridium, sodium fluorescein or mannitol:

1. Intra-operative administration of nitric oxide, prilocaine and sodium nitrite

2. Anuria

3. Women with creatinine greater than 1 or Cr Cl < 50ml/minute

4. Known allergy to pyridium, sodium fluorescein or mannitol.

3. Women with a known urologic anatomical anomaly