Prospective Randomized Trial of Single-Use vs Reusable Cystoscope for Ureteral Stent Removal

Abstract

Background:

Reusable cystoscopes are associated with risks of cross-contamination, need for chemical reprocessing, mechanical breakdown, maintenance costs, and labor for cleaning. A sterile, single-use cystoscope may reduce or eliminate the source of these infections while also decreasing exposure to reprocessing chemical agents. In this multicenter, randomized trial, we sought to compare single use with reusable endoscopes for ureteral stent removal.

Methods:

A three-center, randomized, dual-arm postmarket clinical trial was performed to compare the single-use cystoscope (Ambu A/S) with standard-of-care flexible reusable cystoscopes for outpatient ureteral stent removal. A total of 102 patients were randomized and evaluated from baseline through day 10 postprocedure. Primary endpoint was successful stent removal. Secondary endpoints were time from preparation to disposal/reprocessing, adverse events (AEs), and clinician satisfaction.

Results:

A total of 102 subjects were randomized in a 1:1 manner. The successful stent removal rate was 51/51 (reusable) and 50/51 (single use). One patient required the conversion to reusable cystoscope owing to grasper passage issue. Median time from prep for the procedure to disposal/prep for reprocessing was 10.2 minutes for the single use and 18.4 minutes for the reusable (p < 0.001). There was no difference in clinician satisfaction between both arms. There was no difference in AEs between arms and no device causal attribution for any AE reports. There was one serious AE necessitating hospitalization for infection in the reusable arm.

Conclusion:

The randomized-controlled trial of single-use cystoscopes vs reusables showed comparable device success with significant time savings for single use and equivalent clinician satisfaction. The study was registered on clinicaltrials.gov database (NCT04829461) on April 2, 2021.