Disposable grasper-integrated flexible cystoscope for ureteral stent removal in transplanted patients; focus on feasibility, safety, and patient experience. Results and micro-cost analysis from a tertiary referral center.

INTRODUCTION & OBJECTIVES: To evaluate ureteral stent removal (SR) using a grasper-integrated disposable flexible cystoscope (giFC-Isiris ®, Coloplast ®) after kidney transplantation (KT), with a focus on feasibility, safety, patient experience, and costs. MATERIAL AND METHODS: All consecutive KT undergoing SR through giFC were prospectively enrolled from January 2020 to June 2023. Patient characteristics, KT and SR details, urine culture results, antimicrobial prescriptions, and the incidence of urinary tract infections (UTI) within 1 month were recorded. A micro-cost analysis was conducted, making a comparison with the costs of SR with a reusable FC and grasper. RESULTS: A total of 136 KT patients were enrolled, including both single and double KT, with 148 stents removed in total. The median indwelling time was 34 days [26, 47]. SR was successfully performed in all cases. The median preparation and procedure times were 4 min [3,5]. and 45 s[30, 60], respectively. The median Visual Analog Scale (VAS) score was 3 [1, 5], and 98.2% of patients expressed willingness to undergo the procedure again. Only one episode of UTI involving the graft (0.7%) was recorded. Overall, the estimated cost per SR procedure with Isiris ® and the reusable FC was 289.2€ and 151,4€, respectively. CONCLUSIONS: This prospective series evaluated the use of Isiris ® for SR in a cohort of KT patients, demonstrating feasibility and high tolerance. The UTI incidence was 0.7% within 1 month. Based on the micro-cost analysis, estimated cost per procedure favored the reusable FC.

Single-use digital flexible cystoscope for double J removal versus reusable instruments: a prospective, comparative study of functionality, risk of infection, and costs.

BACKGROUND: The removal of ureteral stent can be performed with disposable or reusable flexible cystoscopes, but limited comparative data are available on functionality, risk of infections, and costs. METHODS: We performed a multicentric, prospective, observational study on patients undergoing in-office ureteral stent removal with Isiris-α® or a reusable Storz™ flexible cystoscope. Study endpoints were the functionality and effectiveness of the devices, the rate of postoperative bacteriuria and UTIs, and the costs of the procedure. RESULTS: A total of 135 patients were included, 80 (59.2%) treated with reusable cystoscopes and 55 (40.8%) with Isiris-α®. No significant baseline differences between groups were detected. Isiris-α® outperformed the reusable device in terms of quality of vision (p 0.001), manoeuvrability (p 0.001), grasper functionality (p < 0.001), and quality of the procedure (p 0.01). Mean procedure time was shorter with Isiris-α® (p < 0.001) due to a shorter instrument preparation time (p < 0.001). No differences were found in terms of perceived patient pain (p 0.34), nor postoperative bacteriuria or symptomatic UTIs. According to our cost analysis, the in-office procedure performed with Isiris-α® was more expensive (+ 137.8€) but was independent from instrument turnover or disinfection. Among limitations of study we acknowledge the lack of randomization, the use of antibiotic prophylaxis in several patients, and the high rate of missing preoperative urine cultures. CONCLUSIONS: Isiris-α® outperforms reusable cystoscopes for in-office ureteral stent removal in terms of total operative time and quality of the procedure, at the cost of being more expensive. No significant differences in postoperative bacteriuria or symptomatic UTIs were found.

Isiris™ for Ureteric Stent Removal in Renal Transplantation: An Initial Single-Centre Experience of 150 Cases.

Background. Ureteric stent insertion is performed at the time of renal transplant to minimise the risk of post-operative urological complications, including anastomotic leak and ureteric stenosis or obstruction. Transplant ureteric stent removal (TUSR) has historically been performed via flexible cystoscopy, predominantly in a theatre setting. Isiris™ is a single-use cystoscope with integrated grasper designed for removal of ureteric stents. We report our initial experience. Methods. A retrospective analysis of a contemporaneously maintained database was performed with review of case notes from October 2017 to September 2018. TUSR was performed by surgical middle grades with a single nurse assistant. Results. One hundred and fifty ureteric stents were removed in transplant recipients (mean age 50.2 years, SD ± 15.2; 61.3% male). 91.3% (n = 137) of cases were performed in the outpatient clinic. Median time to TUSR was 42 days (IQR 30-42). 147 attempts at removal were successful. One urinary tract infection (UTI) was reported following TUSR. Use of the Isiris™ for TUSR corresponds to a £63,480 saving in this cohort compared to conventional practice. This value is conservative and does not include income that has been gained from the reallocation of operating theatre capacity. Conclusion. Isiris™ can safely be employed for the timely performance of non-complicated TUSR. Isiris™ releases this procedure from the confines of the operating theatre to the outpatient clinic. This reduces the resource burden for healthcare providers and may result in improved patient satisfaction. The environmental implications of disposable healthcare equipment require consideration. Evaluation of Isiris™ TUSR for encrustation is required.

The new grasper-integrated single use flexible cystoscope for double J stent removal: evaluation of image quality, flow and flexibility.

BACKGROUND: A new single use digital flexible cystoscope (FC) Isiris α from Coloplast® with an incorporated grasper has been developed to perform double J stent removal. There is a lack of data regarding the comparison of image quality, flexibility and flow between classic cystoscopes and the new Isiris α. MATERIALS AND METHODS: Five different FC were used to compare the image quality, the field of view, the loss of flow and the deflection loss. Two standardized grids, three stones of different composition and a ruler's image were filmed in four standardized different scenarios. These videos were shown to thirty subjects that had to evaluate them. Water outflow was measured in ml/sec in all devices with and without the grasper inside, instruments tip deflection was measured using a software. RESULTS: In the subjective analysis of the image quality Isiris α was the second FC best scored. At 3 cm of distance, the field view of Isiris α was the narrowest. Comparing the water flow in the different FCs, we observed a water flow decrease in all cystoscopes when the grasper was loaded in the working channel. Isiris α deflection and flow increase when the grasper is activated. CONCLUSION: In terms of quality of vision and water flow, the FC Isiris α is comparable to the other digital FC tested. Field of view is narrower. The results displayed a valid alternative to the standard procedure for DJ removal.

Environmental Impact of Flexible Cystoscopy: A Comparative Analysis Between Carbon Footprint of Isiris® Single-Use Cystoscope and Reusable Flexible Cystoscope and a Systematic Review of Literature.

Introduction: There is an absence of data on the environmental impact of single-use flexible cystoscopes. We wanted to review the existing literature about carbon footprint of flexible cystoscopy and analyze the environmental impact of the Isiris® (Coloplast©) single-use flexible cystoscope compared to reusable flexible cystoscopes. Methods: First, a systematic review on single-use and reusable cystoscope carbon footprint was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Second, carbon footprints of Isiris single-use flexible cystoscope and reusable cystoscope were analyzed and compared. Life cycle of the single-use flexible cystoscope was divided in three steps: manufacturing, sterilization, and disposal. For the reusable cystoscope, several steps were considered to estimate the carbon footprint over the life cycle: manufacturing, washing/sterilization, repackaging, repair, and disposal. For each step, the carbon footprint values were collected and adapted from previous comparable published data on flexible ureteroscope. Results: The systematic literature review evidenced total carbon emissions within a range of 2.06 to 2.41 kg carbon dioxide (CO2) per each use of single-use flexible cystoscope compared to a wide range of 0.53 to 4.23 kg CO2 per each case of reusable flexible cystoscope. The carbon footprint comparative analysis between Isiris single-use flexible cystoscope and reusable cystoscope concluded in favor of the single-use cystoscope. Based on our calculation, the total carbon emissions for a reusable flexible cystoscope could be refined to an estimated range of 2.40 to 3.99 kg CO2 per case, depending on the endoscopic activity of the unit, and to 1.76 kg CO2 per case for Isiris single-use cystoscope. Conclusion: The results and our systematic literature review demonstrated disparate results depending on the calculation method used for carbon footprint analysis. However, the results tend rather toward a lower environmental impact of single-use devices. In comparison to a reusable flexible cystoscope, Isiris compared favorably in terms of carbon footprint.

The impact of single-use digital flexible cystoscope for double J removal on hospital costs and work organization: A multicentric evaluation.

BACKGROUND: Isiris-α® is a single-use digital flexible cystoscope with an integrated grasper designed for double J (DJ) stent removal. Aim of this study was to conduct a multicentric evaluation of the costs and criticalities of stent removals performed with Isiris®-α in different hospitals and health systems, as compared to other DJ removal procedures. METHODS: After gathering 10 institutions worldwide with experience on Isiris-α®, we performed an analysis of the reported costs of DJ removal with Isiris-α®, as compared to the traditional reusable equipment used in each institution. The cost evaluation included instrument purchase, Endoscopic Room (EnR)/ Operatory Room (OR) occupancy, medical staff, instrument disposal, maintenance, repairs, decontamination or sterilization of reusable devices. RESULTS: The main factor affecting the costs of the procedure was OR/EnR occupancy. Decontamination and sterilization accounted for a less important part of total costs. Isiris-α® was more profitable in institutions where DJ removal is usually performed in the EnR/OR, allowing to transfer the procedure to outpatient clinic, with a significant cost saving and EnR/OR time saving to be allocated to other activities. In the only institution where DJ removal was already performed in outpatient clinics, there is a slight cost difference in favor of reusable instruments in high-volume institutions, given a sufficient number to guarantee the turnover. CONCLUSION: Isiris-α® leads to significant cost benefit in the institutions where DJ removal is routinely performed in EnR/OR, and brings significant improvement in organization, cost impact and turnover.

Efficacy of the novel, innovative, single-use grasper integrated flexible cystoscope for ureteral stent removal: a systematic review.

BACKGROUND: We aimed to define the published impact, efficacy, cost-effectiveness and precise role of the Isiris-α device: the world's first sterile, single-use grasper integrated flexible cystoscope (SUGIFC) for ureteral stent removal. METHODS: After PROSPERO registration (CRD42021228755), the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were utilized. The search terms "Grasper Integrated Flexible Cystoscope," and "Isiris," within the following databases: PubMed, Scopus, Cochrane Library, Web of Science and EMBASE were searched. RESULTS: In this review, a cumulative total experience (10 publications) included 970 "SUGIFC" procedures (755 patients). However, only 366/970 procedures were actually used for "ureteral stent removal," with the remainder being surveillance cystoscopy only (603/970) or foreign body retrieval (1/970). Procedure-related and device failures in planned "removal of ureteral stents," was reported in 8/366 (346 patients) and 1/366 (346 patients), respectively. The cost-benefit utilizing the SUGIFC device is advantageous compared to "in-theatre" stent removals and favours less busy centres where maintenance, repair and replacement costs are more relevant. Other listed benefits include shorter stent indwelling times, shorter procedure duration, lower rates of bacteriuria and urinary tract infections, fewer emergency department visits and lower readmission rates. Technical limitations include the absence of an independent working channel, a narrower visual field and the lack of image universality since the monitor is device-specific. CONCLUSION: The SUGIFC device needs to be outweighed against local costs and individual health systems. Its application in ambulatory ureteral stent removal may become significant due to the accessibility and convenience that it offers the attending urologist.

Cost-effectiveness analysis of a single-use digital flexible cystoscope for double J removal.

INTRODUCTION AND OBJECTIVE: The novel single-use digital flexible cystoscope Isiris™ has been developed to perform in-office JJ stent removal, without the need of special equipment nor limitations linked to the disinfection of a reusable device. The aim of our study was to perform a cost-effectiveness analysis of Isiris™ in our institution. PATIENTS AND METHODS: A total of 127 consecutive patients undergoing in-office stent removal with Isiris™ were prospectively included in study. After each procedure, the urologist filled a questionnaire specifically developed to evaluate the efficiency of the device and the invasiveness of the procedure. We performed a cost analysis of the main variables involved in JJ removal using Isiris™ versus the traditional Storz™ reusable flexible cystoscope used for all our previous patients. RESULTS: The procedure was successful in all cases except for one, where the device did not work due to the failure of the grasper and had to be replaced. Overall, the performance of Isiris™ was judged by the physician "very good" and "good" in 90.6% of the cases. Both median pain and invasiveness felt by the patient were 0 (range = 0-8). The mean cost of procedure was estimated at €361 for in-office stent removal with Isiris™, and €1.126.8 for stent removal in operatory room with a reusable flexible cystoscope. Considering the 127 procedures performed in office, 64 h of operatory room time was saved. CONCLUSION: In institutions where JJ removal is performed in the operatory room, Isiris™ leads to a significant advantage in terms of money saved per procedure, operatory room time gained and patient satisfaction.

Single-Use Grasper Integrated Flexible Cystoscope for Stent Removal: A Micro-Costing Analysis-Based Comparison.

Background: A single-use flexible cystoscope with integrated grasper (Isiris; Coloplast, Denmark) has recently become commercially available. The objective of our study is to compare the costs of stent removal in an outpatient clinical environment between the single-use Isiris system (Coloplast) to our existing approach using a reusable cystoscope and stent grasper. Materials and Methods: The number of stent removal procedures at our tertiary center was recorded as a proportion of all cystoscopic procedures performed between February 2016 and February 2017. Elements in the micro-cost assessment included original purchasing price of an Olympus digital reusable cystoscope, repair fee (based on a 1-year contract), sterilization equipment and accessory costs, reprocessing costs of the cystoscope, and labor costs. The costs were estimated on a per-use basis and compared to the purchasing price of Isiris. Results: A total of 1775 cystoscopic procedures were performed, and the reusable cystoscope was used for stent removal in 871 (49%) cases. The per-use cost for stent removal procedures using the reusable cystoscope was estimated to be $161.85. The single per-use purchasing price for the Isiris device is $200. Based on the current volume, the break-even point was calculated to be 704 stent pulls. After 704 stent pulls, the cost benefit favors the reusable cystoscope. Conclusion: Based on this micro-cost analysis, per-use costs appear to favor the reusable cystoscope for stent removal. It appears that centers with high volumes of stent pulls may find the reusable cystoscope and stent grasper more cost beneficial than the single-use system.

Comparison of ureteric stent removal procedures using reusable and single-use flexible cystoscopes following ureteroscopy and lasertripsy: a micro cost analysis.

INTRODUCTION: Diagnostic pressure on endoscopy suite can lead to delay in flexible cystoscopic stent removal. We compare the cost and organizational impact of reusable flexible cystoscope versus single-use, flexible cystoscope with a built-in stent grasper (Isiris®). MATERIAL AND METHODS: Data for the reusable cystoscopic stent removal performed in endoscopy room, group A (period 1) were compared to Isiris disposable stent removal performed in outpatient clinic, group B (period 2). We chose the same calendar months in successive years for these two different groups (9 months each). A micro cost analysis was performed evaluating the impact on costs, complications and organizational benefit. RESULTS: A total of 72 patients (37, group A; 35, group B) were included with no significant differences in age and gender ratio. The mean procedure time was 14.4 and 2.2 minutes, and the mean stent dwell time was 26.8 and 15.4 days in groups A and B respectively (p <0.001). In group A, 5 patients (14%) developed stent encrustation, of which 3 needed a ureteroscopic removal subsequently. No complication occurred in group B. More staff on average were needed for procedures done in group A, than group B (p <0.001).The number of patients who had cancer diagnostic wait of >2 weeks for flexible cystoscopy and the mean number of days they waited, reduced from 16 to 3, and 21 days to 3 days respectively between period 1 to period 2. The cost per procedure between group A and group B was £267.2 and £252.62 (p <0.05) if the cost of managing complications was not considered, and £365.40 and £252.62 (p <0.001) if the cost of managing complications was also considered. CONCLUSIONS: Isiris significantly reduced stent dwell time, procedural time and staff needed to carry out the stent removals. It also allowed the procedures to be done in the outpatient setting thereby reducing the organizational pressure on endoscopy related diagnostic procedures.

Isiris: A Novel Method of Removing Foreign Bodies from the Lower Urinary Tract to Avoid Unnecessary Hospitalization and Anesthesia.

BACKGROUND: Polyembolokoilamania refers to the practice of inserting foreign bodies (FBs) into natural orifices. A FB within the urethra is a relatively rare phenomenon with 646 cases recorded last year in the United Kingdom. Management of these patients presents technical challenges and complexities because of underlying psychiatric disorders that are often associated. This case illustrates a novel way of removing FBs from the genitourinary tract, requiring less resources, preventing hospital admission, and attempts to break the cycle of behavior, leading to recurrent attendance with polyembolokoilamania. CASE PRESENTATION: A 38-year-old Caucasian male prisoner, with psychiatric history presented to the emergency department (ED) with a history of inserting FBs into his urethra on 12 different occasions over a 6-week period. Of these 12 attendances, 3 resulted in admission and 2 required emergency intervention in theater under general anesthesia. After the third attendance in 5 days, it was decided to use Isiris™, a single-use flexible cystoscopy device with a built-in ureteral stent grasper, to remove the FBs and check the integrity of the urethra. The procedure was performed within the ED, without the need for admission to a ward bed or general anesthesia. Furthermore, only two members of staff were required to remove all of the urethral FBs. CONCLUSION: Isiris, although marketed as a stent removal device, enabled us to remove all the patient's FBs in one procedure. Isiris is an easy to use device, similar to a flexible cystoscope, that a specialist nurse or resident would be familiar using. It allows efficient and safe removal of lower urinary tract FBs, even out of hours. It requires minimal staffing support and can be done in the ED. It has the potential to reduce associated sequela of urethral polyembolokoilamania, saving resources while preserving the availability of the emergency theater.