PMID- 37565290
OWN - NLM
STAT- Publisher
LR  - 20231023
IS  - 1557-900X (Electronic)
IS  - 0892-7790 (Linking)
VI  - 37
IP  - 10
DP  - 2023 Oct
TI  - Prospective Randomized Trial of Single-Use vs Reusable Cystoscope for Ureteral 
      Stent Removal.
PG  - 1139-1144
LID - 10.1089/end.2023.0134 [doi]
AB  - 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.
FAU - Johnson, Brett A
AU  - Johnson BA
AUID- ORCID: 0000-0002-5026-0359
AD  - Department of Urology, The University of Texas Southwestern Medical Center, 
      Dallas, Texas, USA.
FAU - Raman, Jay D
AU  - Raman JD
AD  - Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
FAU - Best, Sara L
AU  - Best SL
AUID- ORCID: 0000-0001-7285-2833
AD  - Department of Urology, University of Wisconsin-Madison, Madison, Wisconsin, USA.
FAU - Lotan, Yair
AU  - Lotan Y
AD  - Department of Urology, The University of Texas Southwestern Medical Center, 
      Dallas, Texas, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04829461
PT  - Journal Article
PL  - United States
TA  - J Endourol
JT  - Journal of endourology
JID - 8807503
SB  - IM
OTO - NOTNLM
OT  - cystoscopy
OT  - disposable cystoscope
OT  - reusable
OT  - single-use
OT  - ureteral stent removal
EDAT- 2023/08/11 06:42
MHDA- 2023/08/11 06:42
CRDT- 2023/08/11 04:23
PHST- 2023/08/11 06:42 [pubmed]
PHST- 2023/08/11 06:42 [medline]
PHST- 2023/08/11 04:23 [entrez]
AID - 10.1089/end.2023.0134 [doi]
PST - ppublish
SO  - J Endourol. 2023 Oct;37(10):1139-1144. doi: 10.1089/end.2023.0134.