Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial.
To compare different modalities to aid in the evaluation of intraoperative ureteral patency on cystoscopy in the postindigo carmine era.



In a randomized controlled trial, participants undergoing pelvic surgery were randomized into one of four groups: saline distention (control), 10% dextrose distention, oral phenazopyridine, or intravenous sodium fluorescein. Our primary outcome was visibility of the ureteral jets. Secondary outcomes included surgeon satisfaction; adverse reactions including allergies, urinary tract infections, urinary retention, cystoscopy times, and ureteral obstruction; and delayed diagnosis. Participants were followed for 6 weeks. A sample size of 176 participants was planned to demonstrate a 30% difference in the visibility scale. All analyses were performed in an intention-to-treat fashion.



From February 25, 2015, through August 2015, 176 participants were enrolled; 174 completed the trial, and two did not undergo intervention. Forty-four participants were included in the phenazopyridine, dextrose, saline, and sodium fluorescein groups. Sodium fluorescein and 10% dextrose resulted in significantly improved visibility and satisfaction when compared with the control group (P<.001 and P=.004, respectively). Dextrose provided the highest satisfaction and phenazopyridine provided lowest, but visibility was not statistically different between the two groups (P=.101). Three ureteral obstructions were identified intraoperatively and none in the postoperative period. Mean total cystoscopy time varied between 4.0 and 4.8 minutes and postoperative urinary retention rate was 50% across all groups. Overall urinary tract infection rate was 24.1%, which was similar between interventions. There were no related adverse events.



Compared with the control, 10% dextrose and sodium fluorescein resulted in improved visibility and provided significantly more satisfaction in the evaluation for ureteral patency with no considerable increase in operative time or morbidity.



ClinicalTrials.gov, https://clinicaltrials.gov, NCT02476448.
Division of Urogynecology, Lehigh Valley Health Network, Allentown, Pennsylvania; the Departments of Gynecology and Urology, Cleveland Clinic Florida, Weston, Florida; the Department of Gynecology, Cleveland Clinic, Cleveland, Ohio; and the Department of Surgery, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada.
Luis
L
Espaillat-Rijo
Lauren
L
Siff
Alexandriah N
AN
Alas
Sami A
SA
Chadi
Stephen
S
Zimberg
Sneha
S
Vaish
G Willy
GW
Davila
Matthew
M
Barber
Eric A
EA
Hurtado
D061605:Administration, Intravenous; D000284:Administration, Oral; D000368:Aged; D001291:Attitude of Health Personnel; D003558:Cystoscopy / Q000009:adverse effects / Q000379:methods; D005260:Female; D019793:Fluorescein / Q000008:administration & dosage / Q000009:adverse effects; D005456:Fluorescent Dyes / Q000008:administration & dosage / Q000009:adverse effects; D005947:Glucose / Q000008:administration & dosage / Q000009:adverse effects; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects*; D006801:Humans; D007430:Intraoperative Care; D007431:Intraoperative Complications / Q000175:diagnosis* / Q000209:etiology; D008875:Middle Aged; D061646:Operative Time; D010621:Phenazopyridine / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D014513:Ureter / Q000293:injuries*; D014517:Ureteral Obstruction / Q000209:etiology; D016055:Urinary Retention / Q000209:etiology; D014552:Urinary Tract Infections / Q000209:etiology; D014947:Wounds and Injuries / Q000175:diagnosis* / Q000209:etiology
D005456:Fluorescent Dyes; D005947:Glucose; D010621:Phenazopyridine; D019793:Fluorescein