13: Evaluating ureteral patency in the post-indigo carmine era: A randomized controlled trial

Abstract

Many gynecologic, urologic and pelvic reconstructive surgeries require accurate intra-operative evaluation of ureteral patency. The objective of this study is to compare surgeon satisfaction with four methods of evaluating ureteral patency at the time of cystoscopy: phenazopyridine, sodium fluorescein, mannitol, and normal saline. We conducted a randomized controlled trial of the method used to evaluate ureteral patency during cystoscopy at time of benign gynecologic or pelvic reconstructive surgery. Subjects were randomized to 200 mg oral phenazopyridine, 25 mg sodium fluorescein intravenously, mannitol bladder distention, or normal saline bladder distention during cystoscopy to evaluate ureteral patency. The primary outcome was surgeon satisfaction with the method, which was assessed via a 10 cm Visual Analog Scale (VAS). A priori sample size of 137 participants was planned to detect a 3 cm difference in the VAS scale with 80% power and a 2-tailed alpha of 0.05, including 10% added for participant dropout. Demographic and operative information, including time to confidence in the ureteral jets was collected. Adverse events were followed for at least 6 weeks after the surgical procedure. Two hundred nine patients were screened for eligibility, 193 met inclusion criteria, and 140 were consented and enrolled in the study. One hundred thirty subjects were randomized and evaluated according to intention-to-treat into four groups: phenazopyridine (n = 33), sodium fluorescein (n = 32), mannitol (n = 32), and normal saline (n = 33). Demographics were similar between groups with mean/standard deviation age of 50 years (12) and BMI 29 (7), and median/range parity 2 (0, 8). Forty-two percent were Hispanic, 31% white, 19% African American, 2% Asian, and 6% unknown/other. Indications for surgery were similar across groups and included AUB/fibroids (48%), prolapse (28%), incontinence (12%), and microhematuria (4%). Type of surgery did not differ across groups and included 55% hysterectomy, 42% pelvic reconstruction, and 26% incontinence surgery. With regard to the primary outcome, mannitol was noted to be the most satisfactory method to physicians for assessing ureteral patency (p < 0.001). Mannitol was also the easiest method to use and the agent that provided the clearest and most definitive visualization of the ureteral jets, bladder mucosa and urethra (all p < 0.001). Surgery length, cystoscopy length, and time to confidence in ureteral jets were not different between groups (all p > 0.05). During the 111 day median follow-up, there was no significant difference in adverse events noted among the groups, including urinary tract infections (all p > 0.05). The use of mannitol during cystoscopy to assess ureteral patency provided surgeons with the most overall satisfaction, ease of use, and superior visualization without impacting surgery or cystoscopy times. There were no differences in adverse events, including urinary tract infections.