Single-Use Versus Reusable Digital Flexible Ureteroscopes for the Treatment of Renal Calculi: A Prospective Multicenter Randomized Controlled Trial

Qi, Shiyong; Yang, Enguang; Bao, Jiguang; Yang, Ningqiang; Guo, Hongfeng; Wang, Gang; Li, Ning-chen; Cui, Xin; Gao, Wei; Ou, Tongwen; Wang, Jiaji; Wang, Zhiping; Niu, Yuanjie

doi:10.1089/end.2019.0473

Cited by 29 publications

(56 citation statements)

References 23 publications

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“…Four included studies provided enough data available on operative time (14,(18)(19)(20). In Kam's study, two different models of single-use FURS were compared with the same traditional FURS.…”

Section: Operative Timementioning

confidence: 99%

“…Four trials with 686 participants described the SFR (7,(18)(19)(20), and pooled results indicated that compared to reusable FURS, single-use FURS provided a significantly higher SFR (OR: 1.50; 95% CI, 1.06-2.12; P=0.02) (Figure 4) without detection of statistical heterogeneity (I 2 =0%). In the studies by Qi…”

Section: Sfrmentioning

confidence: 99%

“…Four included studies with 842 participants had enough data relevant to perioperative complications (14,(18)(19)(20), and ORs were used for statistical analysis. Due to the detection of high statistical heterogeneity (I 2 =56%), a randomeffect model was used.…”

Section: Perioperative Complicationsmentioning

confidence: 99%

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Comparison of single-use and reusable flexible ureteroscope for renal stone management: a pooled analysis of 772 patients

Chen

Zhu

et al. 2021

Transl Androl Urol

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Flexible ureteroscopy is a common therapy for patients with renal calculi. In recent years, the prevalence of single-use flexible ureteroscope (FURS) use has been on the rise. Thus, several trials have been conducted to compare the efficacy between single-use and reusable FURS. The aim of this meta-analysis was to systematically assess the effectiveness and safety of single-use vs. reusable FURS in treating renal stones.PubMed, Web of Science, Cochrane Library and EMBASE were researched to identify relevant studies up to September 2019. Article selection was performed through the search strategy based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. The Newcastle-Ottawa Scale was applied to assess the methodological quality of non-randomized controlled trials, and the methodological quality of randomized controlled trials was evaluated using the Jadad scale. A total of five studies with 772 patients were included in the meta-analysis, including two randomized controlled trials, two single-centre prospective studies, and one prospective case-control trial. The pooled results showed that single-use FURS was associated with a higher stone-free rate (SFR) (OR: 1.50; 95% CI, 1.06-2.12; P=0.02) than reusable FURS.

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Section: Operative Timementioning

confidence: 99%

Section: Sfrmentioning

confidence: 99%

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Comparison of single-use and reusable flexible ureteroscope for renal stone management: a pooled analysis of 772 patients

Chen

Zhu

et al. 2021

Transl Androl Urol

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“…A single-use digital FURS ZebraScope™ was utilized in the trial group during surgery, with a reusable digital FURS (URF-V, Olympus, Tokyo, Japan) used in the control group. The structures and major parameters of the ZebraScope™ were introduced in our previous study [9].…”

Section: Introductionmentioning

confidence: 99%

Single-Use Digital Flexible Ureteroscopes as A Potential Choice for the Treatment of Lower Pole Renal Stones: A Multicenter Case-Control Study

Yang

Jing

Niu

et al. 2020

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Background: To compare the efficacy and safety of a single-use digital flexible ureteroscope (FURS) and a reusable FURS for the treatment of lower pole stones (LPS) smaller than 20 mm.Methods: A prospective case-control study was conducted using the clinical data from a multicenter, randomized, open-label clinical trial in four hospitals in China. A single-use digital FURS ZebraScope™ was utilized in the trial group during surgery, with a reusable FURS URF-V used in the control group. The efficacy endpoints assessed were the 1-month postsurgical stone-free rate (SFR), operative time, length of postoperative hospital stay, and mean reduction in hemoglobin level. The safety outcomes assessed were the presence of adverse events (AEs), severe AEs (SAEs), and postoperative complications.Results: In total, 49 patients with LPS underwent surgery using FURS. The demographic and preoperative parameters were comparable between the 2 groups. The 1-month SFR was 84.00% for the ZebraScope™ group and 58.33% for the URF-V group (P<0.05). There was no difference between the two groups in the operative time (P=0.665), the length of hospital stay (P=0.308), the presence of postoperative complications (P=0.307), the presence of AEs (P=0.483)，and the presence of SAEs (P = 0.141). Conclusions: This study demonstrates that single-use digital FURS is a safe and effective option and can offer higher SFR than the reusable FURS in the treatment of LPS smaller than 20 mm. We recommend single-use digital FURS as an alternative to reusable FURS for the treatment of LPS.Trial registration: The trial was registered in Chinese Clinical Trial Registry. The registration number: ChiCTR1900021615. Date of registration: 1/3/2019. This trial was registered retrospectively.

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“…The original disposable ureteroscope, LithoVueÔ, was developed by Boston Scientific Corporation in 2015 and has been extensively evaluated against commercially available reusable ureteroscopes. 3e7 Clarion Medical Technologies followed with the Pusen Uscope, 8 and now there are multiple devices, including ZebraScopeÔ (Happiness Workshop), 9 Cook Medical, 10 WiScopeÔ (Bard) 11 and Axis. 12 Despite the major advances in endoscopic technology, there remain benchmark metrics that are required for all endoscopes, including: visual acuity, tip diameter and agility, scope safety, durability and cost.…”

mentioning

confidence: 99%

Initial Experience with Novel Single-Use Disposable Ureteroscopy: A Prospective, Single Arm 90-Day Trial of the Axis Ureteroscope

et al. 2021

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Introduction: Novel digital disposable ureteroscopes are becoming more commonplace in endourological practices. We trialed the AxisÔ single-use ureteroscope, which is distributed within the United States by Dornier MedTech. Our goal was to demonstrate clinical equivalence to our reusable platform and to evaluate the cost-effectiveness of a single-use digital ureteroscope.Methods: We conducted a prospective 90-day trial where all flexible ureteroscopic procedures were completed using the single-use ureteroscope. The cases were monitored for scope failure, scope deficiencies and surgeon satisfaction scores via an immediate postoperative REDCapÒ survey. We also performed a cost analysis between reusable scopes and the single-use ureteroscope. The cost of the reusable platform included the amortized initial purchase, maintenance and clean processing.Results: Over a 90-day period, we performed 93 flexible ureteroscopy procedures with a single-use ureteroscope, of which 74 were completed using Axis. After controlling for operating room time and disposable items used, the utilization of Axis was associated with an average reduction of $140.31 per case. Extrapolating the per-case savings over an annual case volume, we estimate a total savings of $56,127.15. There were no disposable scope malfunctions. There were 4 (4.3%) cases converted to reusable scopes due to image quality (1), inadequate secondary deflection (2) and a tight ureter (1). MeanAESD score for image quality, mobility and ergonomics was 9.1AE1.1, 8.9AE1.1, 9.3AE1.1, respectively. The 90-day complication rates were equal to our controls. Conclusions:We demonstrated that the Axis single-use digital ureteroscope is equivalent in function to our digital reusable scope and reduced the cost of flexible ureteroscopy.

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Single-Use Versus Reusable Digital Flexible Ureteroscopes for the Treatment of Renal Calculi: A Prospective Multicenter Randomized Controlled Trial

Cited by 29 publications

References 23 publications

Comparison of single-use and reusable flexible ureteroscope for renal stone management: a pooled analysis of 772 patients

Comparison of single-use and reusable flexible ureteroscope for renal stone management: a pooled analysis of 772 patients

Single-Use Digital Flexible Ureteroscopes as A Potential Choice for the Treatment of Lower Pole Renal Stones: A Multicenter Case-Control Study

Initial Experience with Novel Single-Use Disposable Ureteroscopy: A Prospective, Single Arm 90-Day Trial of the Axis Ureteroscope

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