Luis Espaillat-Rijo1, Lauren Siff, Alexandriah N Alas, Sami A Chadi, Stephen Zimberg, Sneha Vaish, G Willy Davila, Matthew Barber, Eric A Hurtado. 1. 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.
Abstract
OBJECTIVE: To compare different modalities to aid in the evaluation of intraoperative ureteral patency on cystoscopy in the postindigo carmine era. METHODS: 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. RESULTS: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 thephenazopyridine, 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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02476448.
RCT Entities:
OBJECTIVE: To compare different modalities to aid in the evaluation of intraoperative ureteral patency on cystoscopy in the postindigo carmine era. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02476448.
Authors: Elizabeth M Strom; Zaid Q Chaudhry; Rong Guo; Axeline J Maisonet; Christine H Holschneider; Cecilia K Wieslander Journal: Female Pelvic Med Reconstr Surg Date: 2019 Jul/Aug Impact factor: 2.091
Authors: Matthew T Siedhoff; Kelly N Wright; Meenal A Misal; Andrea L Molina; Naomi H Greene Journal: J Minim Invasive Gynecol Date: 2020-07-08 Impact factor: 4.137