DENVER – Ureteral jets were best visualized during cystoscopy with the help of 10% dextrose or sodium fluorescein, instead of phenazopyridine or normal saline, findings from a multicenter, randomized controlled trial suggested.
User satisfaction also was significantly higher with 10% dextrose and fluorescein, compared with the other interventions, Luis Espaillat-Rijo, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
Average total cystoscopy time, time to first jet visualization, and rates of postoperative urinary tract infections were similar among groups, noted, who conducted the research at the Cleveland Clinic Florida in Weston.
Historically, surgeons used intravenous indigo carmine to evaluate ureteral patency during intraoperative cystoscopy, but the Food and Drug Administration announced ain June 2014 that has not resolved.
Hypothesizing that not all alternatives confer equivalent visibility, the researchers randomly assigned 174 female cystoscopy patients aged 18 years or older to one of four: intravenous sodium fluorescein, preoperative oral phenazopyridine (Pyridium), 10% dextrose solution, or normal saline (control).
The researchers excluded patients with kidney disease or a history of surgery for renal or ureteral obstruction. The primary outcome was visibility of the urine jet, which surgeons described as clearly visible, somewhat visible, or not at all visible. Surgeons also were asked how satisfied or confident they were in assessing ureteral patency with the test media, Dr. Espaillat-Rijo said.
The study groups were demographically similar. Fluorescein and 10% dextrose resulted in the highest visibility, with more than 80% of surgeons describing the ureteral jets as “clearly visible” with these modalities, compared with about 60% of cases in which phenazopyridine or saline was used (P = .001, for differences among groups).
Similarly, more than 80% of surgeons reported being very or somewhat satisfied with 10% dextrose and fluorescein, while about 60% of surgeons said they were very or somewhat satisfied with phenazopyridine and saline (P less than .001).
“It was interesting that phenazopyridine was not more visible than control saline,” Dr. Espaillat-Rijo said. “Surgeons also noted that it was harder to evaluate the uroepithelium when it was tinged with Pyridium.”
Use of these interventions did not add time to the procedure, he noted. Total cystoscopy time averaged 4.5 minutes and was similar among groups. Average time to detection of the first jet also was similar among all four interventions, ranging from 1.8 to 2.5 minutes.
None of the patients had allergic reactions or adverse events considered related to an intervention. The rates of urinary tract infection ranged from approximately 22% to 30% and were similar among groups. Three ureteral obstructions were correctly identified and released intraoperatively, and none was identified postoperatively. One patient had an episode of acute urinary retention 4 days after surgery that led to bladder rupture.
“Because we had no postoperative ureteral injuries, we were unable to detect the sensitivity or specificity for each method,” Dr. Espaillat-Rijo said. “Another limitation is that we did not have the power to find a difference in our secondary outcomes, and indigo carmine was not used as a control.”
The Cleveland Clinic Florida sponsored the study. The researchers reported having no relevant financial disclosures.