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The “ins and outs” of the magnetic ureteral stent: A novel innovation in Endourology

The “ins and outs” of the magnetic ureteral stent: A novel innovation in Endourology Background: Ureteral stents play a major role in maintaining ureteral patency. Various innovations are advocated in the design and sub- sequent removal of traditional double-J ureteral stents, such as the magnetic-end double-J ureteral stent (MEDJUS). This stent facili- tates outpatient removal using a magnetic stent removal device. This systematic review was conducted to analyze the published role, efficacy, and outcomes of MEDJUS. Materials and methods: After PROSPERO registration (CRD42021235739), an electronic database search (PubMed, EMBASE, Cochrane Library, Scopus, and Web of Science) was performed on December 31, 2020. The search terms were as follows: “magnetic,” “ureteric,”“stent,” “double-J,” “urotech,” and “Black-Star.” Results: Nine studies with a total of 685 patients were included in the systematic review. The total number of MEDJUS procedures used was 498 (73%) compared to the 187 (27%) traditional double-J stent method. Magnetic-end double-J ureteral stent extraction failure was reported in 8 cases (1.61%). Compared with traditional stents, MEDJUS showed a cost benefit in 5/5 studies. Better pain scores (during stent in situ) and (at stent removal) were observed in 2/3 and 3/4 of the studies, respectively. Conclusions: Magnetic-end double-J ureteral stent may serve as a viable alternative to traditional double-J stents, offering cost and pain benefits with similar rates of complications. Magnetic-end double-J ureteral stent also offers relative ease of extraction and a re- duced need for inpatient removal. This ambulatory stent removal technique has forged its use in modern urological practice. Keywords: Double-J; Innovation; Magnetic stentMagnetic stent; Stent removal 1. Introduction Ureteral stents are removed either using cystoscopy in an out- patient setting or in the operating theatre. These procedures consequently result in additional procedural costs, longer hospi- Ureteric stenting is a common urological procedure that is used to tal stay, and patient discomfort, with symptoms such as pain, he- maintain ureteral patency. Stenting is effective in ureteral obstruc- [5] maturia, and lower urinary tract symptoms. Fortunately, recent tion, in which the lack of optimal surgical decompression of the innovations in stent material, properties, and design are all aimed urinary tract can lead to urinary tract infection (UTI), renal insuf- [1–6] at reducing the disadvantages of traditional ureteric stent removal, ficiency, or even renal failure. [6,8,9] as well as reducing stent-related complications. One innovation Stent insertion may also be performed prophylactically to mitigate has been the use of magnetic-end double-J ureteral stent (MEDJUS), the risk of ureteric obstruction, stricture formation, and colic symp- which can be removed by using a magnetic retrieval device in an out- toms, following various urological and nonurological procedures. patient setting. The rationale behind the creation and use of mag- Prolonged ureteric stent insertion has been linked to bacterial netic stents is to avoid the need for cystoscopy when removing ure- colonization and encrustation, leading to UTI, obstruction, and teric stents, and many versions of MEDJUS have been attempted [2,3] lower urinary tract symptoms. early stent removal is the most over the past decade. Previous attempts have led to dissatisfaction [7] important factor for preventing unwanted complications. and serious safety concerns. However, recent developments have demonstrated improved safety, feasibility, and patient satisfaction [10,11] for clinical use. *Corresponding Author: Ahmed Adam, Division of Urology, Department of Surgery, The novel, innovative, magnetic double-J ureteral stent (Blackstar, Faculty of Health Sciences, University of the Witwatersrand, 7 York Road, Parktown, Urotech [Achenmühle, Germany]) is made of polyurethane and has Johannesburg 2193, South Africa. E-mail address: aadam81@gmail.com (A. Adam). a cylindrical magnet attached to the distal stent coil (Fig. 1). The Current Urology, (2023) 17, 2, 92–99 magnet was attached via a looped string knotted to the distal stent. Received February 10, 2022; Accepted May 24, 2022. The removal device was a Tiemann tip 30°-angulated device con- http://dx.doi.org/10.1097/CU9.0000000000000104 structed from soft polyurethane. The midline yellow line demarcates Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. This the center or midline region of the removal device to allow orienta- is an open-access article distributed under the terms of the Creative Commons tion of the surgeon. This angulated tip allows easy navigation Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it through the male urethra and lateral deviation once inside the is permissible to download and share the work provided it is properly cited. The bladder, to attract the cylindrical magnetic bead attached to the work cannot be changed in any way or used commercially without permission [8] from the journal. distal stent coil. 92 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Figure 1. Magnetic double-J ureteral stent (Urotech Black-Star). Photographic image of the magnetic double-J ureteral stent (Urotech Black-Star) depictingthe following: (A) Magnetic distal stent coil (26 cm length/2 mm diameter) and magnetic retrieval device (40 cm length/5 mm diameter); (B) Magnetic retrieval device approaching the magnetic bead tied to the distal stent coil; (C) Magnetic attraction with an “audible click”; (D) A steady pull allows stent retrieval. Given such developments regarding MEDJUS use, this systematic 2.4. Study quality and checklist review was conducted to critically appraise the published efficacy, The Critical Appraisal Skills Program (2018) Oxford (Cohort [12] cost-saving aspects, pain response, symptomatology, indwelling dura- Study) Checklist, was used to assess the underlying study qual- tion, extraction failure, and general outcomes related to MEDJUS use. ity within the studies appraised. 2. Materials and methods 3. Results 2.1. Search strategy In total, 17 related studies were identified. After screening for eligi- After PROSPERO registration was attained (certificate no.: bility, relevance, and relatedness, 9 studies were included for ap- [4–10,13,14] CRD42021235739), an electronic database search (PubMed, praisal (Fig. 2). These 9 studies included 3 retrospective [5,9,10] [4,8,14] EMBASE, Cochrane Library, Scopus, and Web of Science) was studies, 3 randomized control trials, 2 prospective [6,13] [7] performed on December 31, 2020. The following search terms were uti- studies, and 1 case-control study. The 8 excluded articles [15–17] [18] lized: “MEDJUS,”“ureteric,”“stent,”“double-J,”“urotech,” and consisted of 3 ongoing clinical trials, 1 case report, 1cost [19] “Black-Star.” These terms were combined using Boolean operators evaluation, 2 papers were updated pilot studies from the same [20,21] [22] (AND and OR) to refine the search. Articles retrieved underwent cita- authors, and 1 conference abstract (Table 1). tion and reference review to further identify any missed relevant or re- lated studies. This study received local institutional ethics certification 3.1. Appraised studies and patient demographics (W-CBP-210504–01). The 9 included studies (Table 1) had a combined total of 685 pa- tients. Eight studies recorded the sex of the patients, with Mitchell [10] 2.2. Inclusion and exclusion criteria et al. being the only study not documenting this variable. The The inclusion criteria were full-text articles and reports on the use results of the studies that documented the sex showed a male pre- of magnetic ureteric stents. The types of articles included pediatric, dominance (458 male vs. 147 female), with a male:female ratio clinical comparative, nonclinical comparative, and cost evaluation/ of 3:1 (Table 2). The total number of MEDJUS procedures used comparison studies. Case reports, abstracts only, conference pro- was 498 (73%) compared to the 187 (27%) traditional double-J ceedings, cost-only comparisons, nonmagnetic stents, and pilot stent method. Two studies involved a pediatric cohort assessing studies were excluded from this review. MEDJUS stent usage in 164 children (80 and 84 children, [10,14] respectively). 2.3. Data extraction Studies that met the inclusion criteria were assessed in the journal of 3.2. Pain response and tolerance [4–9,13,14] publication, period of review, study type, geographic region, number Eight studies assessed pain associated with MEDJUS use. of patients, demographic details, associated pain, complications, uri- Pain scoring was assessed using the Ureteral Stent Symptom Ques- [4,5,7] nary symptoms, adverse events, stent extraction failure, and reported tionnaire (USSQ) alone in 3 studies, using the Visual Analog [9,13] cost benefits. The extracted data were filtered into raw numbers either Scale for pain in 2 studies, and 2 studies assessed pain using from the conversion of a percentage of the study group or directly. both the USSQ and Visual Analog Scale pain assessment tools 93 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Figure 2. PRISMA flow diagram summarizing literature review. [6,8] (Table 4). Chaloub et al. assessed pain without using any of benefit per case with MEDJUS use compared to traditional [14] these assessment tools. The average pain score for the MEDJUS double-J stent use. All studies reported cost benefits across 4 coun- [4,6,8] [7] [5] (stent in situ) was 2.46, compared with 2.94 for the traditional tries, 3 being European, 1African, and 1 North American [5,6,8,13] double-J stent. Similarly, the average pain score for stent re- (Table 4). moval was lower within the MEDJUS group compared with the tra- [4–6,8,13,14] ditional double-J stent group: 2.78 and 4.03, respectively. 3.5. Complications Two studies found that postoperative morbidity related to MEDJUS The most common complication found in 4 studies was sporadic [7,8] use was significant. However, two other studies reported that infection. Mitchell et al. and O’Kelly et al. reported a single case [4,5] [4,10] postoperative morbidity was not statistically significant. each with complicated UTI and fever requiring hospitalization. In addition, Chalhoub et al. reported that 5 children were treated [14] 3.3. Stent indwelling time, extraction time and failure of with oral antibiotics for febrile UTI. Thus, the total reported removal MEDJUS-related UTI incidence was 7 cases in this review. When assessing the published data regarding the cumulative 685 Two studies noted a single case of stent encrustation due to pro- patients (514 MEDJUS:187 conventional stents), extraction time longed indwelling time secondary to postoperative anastomotic [5,8] ranges were acceptable, with an overall extraction failure in only leaks and postoperative laparoscopic pyeloplasty. 8 instances (1.61%) (Table 3). Another study highlighted a marginal increase in stent irritation in the MEDJUS group compared with the traditional double-J [13] 3.4. Cost stent group. However, no significant differences in stent irrita- Five studies incorporated a cost analysis, comparing MEDJUS to tion were found in the cohort of patients carrying and indwelling [4–8] [13] the traditional double-J stent. All 5 studies reported a cost stents for 4 weeks (Table 4). 94 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Table 1 Summary of articles assessing magnetic ureteric stent use. Author Ref Study type Journal Year Period of review Country Study content Comparator Authors’ conclusions Rassweiler et al., 2017 [8] Prospective RCT J Endourol 2017 Oct 2013–Oct 2014 Germany Evaluate and compare the magnetic USSQ,VAS,removal time, The discomfort caused by the indwelling magnetic DJ stents to a standard DJ regarding cost analysis DJ is comparable to the standard DJ. However, quality of life with indwelling DJs as well the magnetic DJ-removal is less painful and as discomfort during the removal. faster. Sevcenco et al., 2018 [12] Prospective World J Urol 2017 Nov 2013–July 2015 Germany Assessment of the morbidity, complication VAS, urine culture result, The magnetic-end ureteric double-J stent is a safe rate, and pain perception during removal renal ultrasonogram option associated with less pain, particularly for of a novel ureteric stent with a magnetic male patients requiring short-term ureteric stenting. end using a-traumatic retrieval catheter. Pohlmann et al., 2019 [6] Prospective Int J Organ 2019 - Germany Assessment of the functional efficacy and feasibility USSQ,VAS,removal time, Using magnetic ureteral stents is a feasible option Transplant Med of magnetic DJ stents in kidney transplant cost analysis for living donation AB0-identical kidney recipients. transplant recipients. Farouk et al., 2019 [7] Prospective RCT Turk J Urol 2019 Dec 2018–Mar 2019 Egypt To evaluate and compare the morbidity of the USSQ, procedure cost, The morbidity caused by the magnetic DJ was magnetic stent to the standard stent and application, retrieval found to be higher. However, the removal of evaluate the possibility of retrieving the magnetic accuracy, and discomfort the magnetic DJ was less costly than the tip of the DJ stent without cystoscopy. standard DJ. Capocasale et al., 2019 [9] Retrospective Transplantation 2019 Apr 2015–Sept 2018 Italy Analysis of magnetic ureteric stents in Extraction time, VAS pain, Magnetic stents appeared to be safe and analysis 100 consecutive kidney transplants adverse events cost-effective. They should be implemented in kidney transplant reciepients O’Kelly et al., 2020 [4] Retrospective Ir J Med Sci 2020 Sept 2016–July 2017 Ireland Comparison of magnetic stent and standard USSQ, stent duration, pain Magnetic stents cause similar morbidity compared analysis ureteric stents with regard to morbidity, pain on on stent removal, cost with standard stents removed by flexible stent removal and cost-effectiveness. analysis, complications cystoscopy; they are associated with less pain at removal and are cost saving. Kapoor et al., 2020 [5] Prospective RCT Can Urol Assoc J 2020 May 2017–Apr 2018 Canada Comparison of clinical and cost-related outcomes USSQ, clinical, procedural, Black-Star® stent was well-tolerated when of conventional and magnetic stents in patients and cost outcomes, stent compared to the conventional stent and is undergoing deceased donor renal removal potentially cost-saving transplantation. Mitchell et al., 2020 [10] Case-control J Pediatr Surg 2020 May 2017–May 2018 Canada Demonstration of the safety and efficacy of Stent Duration, retrieval Magnetic stents represent a safe and effective study magnetic stents in pediatric patients. alternative to traditional stents, especially in a pediatric patient. Chalhoub et al., 2020 [14] Retrospective World J Urol 2020 Nov 2016–Dec 2019 Germany Assessment of feasibility and safety of insertion Stent insertion, stent removal, The use of a MEDJUS is a safe and effective analysis and removal of a MEDJUS in a pediatric pain score, urinary solution for ureteral stenting without exposing population. symptoms children to additional GA. DJ = double-J; GA = general anesthesia; MEDJUS = magnetic-end double-J ureteral stent; RCT = randomized controlled trial; USSQ = Ureteric Stent Symptom Questionnaire; VAS = Visual Analog Scale. Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Table 2 Summary of patient demographics (journals listed in order of publication). Author Ref No. of patients Male: Female Mean age (range) Magnetic stent: Traditional stent Rassweiler et al., 2017 [8] 60 47:13 47.5 (23–75) 40:20 Sevcenco et al., 2018 [12] 163 151:12 50.5 130:33 Pohlmann et al., 2019 [6] 7 3:4 48.7 7:0 Farouk et al., 2019 [7] 50 35:15 31.08 (19–50) 25:25 Capocasale et al., 2019 [9] 100 65:35 - (22–74) 100:0 O’Kelly et al., 2020 [4] 100 73:27 48.7 50:50 Kapoor et al., 2020 [5] 41 27:14 60.41 22:19 Mitchell et al., 2020 [10] 80 - 5.3 40:40 Chalhoub et al., 2020 [14] 84 57:27 7.8 (0.5–18) 84:0 Total 685 3:1 498:187 3.6. Pediatric experience multitude of complications during the stent indwelling period [7,14] Mitchell et al. reported 1 case of UTI and 1 case of magnetic stent and subsequent removal. insertion failure among 40 pediatric cases. They recommended Alternative stents such as MEDJUS have been introduced to alle- passing the magnetic stent in a prograde fashion in children aged viate these complications in patients. The following variables were [10] <2 years undergoing pyeloplasty. assessed: geographical location, demographics, stent dwell time, Chalhoub et al. attempted MEDJUS in 100 children, with stent stent extraction time, number of failed stent removals, cost benefit, insertion performed in a retrograde, anterograde, and open fash- pain score, postoperative mobility, and urinary symptoms (Table 1). ion. All stent insertion failures 16/100 occurred in an anterograde Various geographical regions were represented, with most stud- manner during laparoscopic pyeloplasty. Stent insertion was suc- ies being European, 1 study by Farouk et al. conducted in Egypt, cessfully performed in 84/100 cases assessed. There were 2/100 and 2 studies conducted in Canada by Kapoor et al. and Mitchell [5,7,10] stent removal failures occurred in cases in which the magnetic et al. The feasibility of conducting such studies in the afore- [14] bead was unreachable within the bladder diverticulum. mentioned regions may be explained by established resource accessi- bility and advanced healthcare systems. However, there is a no- 3.7. Quality of the studies assessed ticeable paucity of literature regarding MEDJUS within poorer When assessing the quality grading of the articles selected using the socio-economic global regions, and as such, further research is re- [12] Critical Appraisal Skills Program (Oxford) system, 6cohort quired to adequately assess the utility thereof in such settings. studies (Table 5) and 3 randomized control trial studies (Table 6) The male predominance in the review may be a confounding scored favorably. variable for many factors assessed in the review. Nonetheless, MEDJUS use revealed lower pain scores upon removal of the MEDJUS stents compared to the use of the double-J ureteral [4,6,8,13] 4. Discussion stent. Prolonged stent dwell time has been associated with adverse ef- [4,8–10] Traditional double-J ureteral stents are commonly used to main- fects, such as infections and stent encrustation. Thus the [10] tain ureteral patency; however, they have been associated with a MEDJUS stent indwelling time of 28?days is advocated. Table 3 Summary of articles assessing stent dwell time, extraction time, and failure of removal. Mean stent duration (d) Mean extraction time (min) Mean extraction time (min) Reference Magnetic Traditional Magnetic Traditional Magnetic Traditional number stent stent stent stent stent stent Rassweiler et al., 2017 [8] - - 9.55 including 21.35 1 (2.5%) 0 the cleaning time Sevcenco et al., 2018 [12] 7.0 28.0 7.0 (no -- 1(0.7%) - (additional additional cohort) cohort) Pohlmann et al., 2019 [6] 30.0 - 3.4 - 0 - Farouk et al., 2019 [7] - - - - 0 0 Capocasale et al., 2019 [9] - - 83 (83%): <0.5 - 2 (2.0%) - 15 (15%): 0.5-3 O’Kelly et al., 2020 [4] 5.5 21.5 - - 0 0 Kapoor et al., 2020 [5] - - 4.8 6.67 1 (4.5%) - Mitchell et al., 2020 [10] 36.8 48.8 - - 1 (2.5%) 0 Chalhoub et al., 2020 [14] - - 4.0 - 2 (2.4%) - Total 8(1.61%) 96 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Table 4 Summary of cost benefit, pain scores, postoperative morbidity and urinary symptoms. Mean pain score (stent in situ) Mean pain score (stent removal) Reference Magnetic Traditional Magnetic Traditional Postoperative Urinary number Cost benefit stent stent stent stent morbidity (USSQ) symptoms Rassweiler et al., 2017 [8] €101.41 3.00 5.00 3.00 4.00 Significant - Sevcenco et al., 2018 [12] Not given 2.42 2.15 2.17 5.88 - - Capocasale et al., 2019 [9] Not given - - - - - - Farouk et al., 2019 [7] 1156 LE - - - - Significant Significant Pohlmann et al., 2019 [6] €130 2.67 - 2.60 - - - Chalhoub et al., 2020 [14] Not given - - 3.00 - - - Kapoor et al., 2020 [5] $304.02 CAD 1.75 1.68 3.00 2.33 Not significant Not significant Mitchell et al., 2020 [10] Not given - - - - - - O’Kelly et al., 2020 [4] €203 - - 2.90 3.90 Not significant Not significant $ = US Dollar; € = Euro; CAD = Canadian Dollar; LE = Egyptian pound; USSQ = Ureteric Stent Symptom Questionnaire. Table 5 Details of the Critical Appraisal Skills Program tool used to assess cohort studies included for review. O’Kelly Pohlmann Capocasale Mitchell Sevcenco Chalhoub et al., 2020 et al., 2019 et al., 2019 et al., 2020 et al., 2018 et al., 2020 Reference number [4] [6] [9] [10] [12] [14] Did the study address a clearly focused issue? Y Y Y Y Y Y Was the cohort recruited in an acceptable way? Y N Y Y Y Y Was the exposure accurately measured to minimize bias? Y Y Y N Y Y Was the outcome accurately measured to minimize bias? Y Y Y Y Y Y Have the authors listed all confounding factors? Y Y CT Y Y CT Have the authors taken account of all the confounding factors? Y Y CT Y Y N Was the follow-up complete enough? CT Y Y CT Y Y Was the follow-up long enough? CT Y Y CT Y Y Do you believe the results? Y Y Y Y Y Y Can the results be applied to a local population? Y N Y Y Y Y Do the results of the study fit with other available evidence? Y Y Y Y Y Y CT = cannot tell; N = no; Y = yes. Table 6 Details of the Critical Appraisal Skills Program tool used to assess randomized control trial studies included for review. Kapoor Farouk Rassweiler et al., 2020 et al., 2019 et al., 2017 Reference number [5] [7] [8] Did the study address a clearly focused research question? Y Y Y Was the assignment of participants to intervention randomized? Y Y Y Were all participants who entered the study accounted for at its conclusion? Y Y Y Were the participants blind to the intervention they were given? N N Y Were the investigators blind to the intervention they were giving to participants? N N N Were the people assessing/analyzing the outcomes blinded? N N N Were the study groups similar at the start of the randomized controlled trial? Y Y Y Apart from the experimental intervention, did each study group receive the same level of care? Y Y Y Were the effects of intervention reported comprehensively? Y Y Y Was the precision of the estimate of the intervention or treatment effect reported? N Y Y Do the benefits of the experimental intervention outweigh the harms and costs? Y Y Y Can the results be applied to your local population/in your context? Y Y Y Would the experimental intervention provide greater value to the people in your care than any of the existing interventions? Y Y Y CT = cannot tell; N = no; Y = yes. 97 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org [8,10] External factors due to delays in stent removal were accounted for double-J stents; however, this difference was marginal. Farouk [6,10] within the studies by Mitchell et al. and Pohlmann et al. et al. and O’Kelly et al. found no evidence of failed removal in ei- [4,7] Assessing the time taken to extract the MEDJUS and magnetic ther the MEDJUS or traditional double-J stent groups. stent removals were more efficient than traditional double-J stent A potential disadvantage is the relative pain experienced by pa- removals. However, there was a marginal increase in the number tients. This point is worth noting; however, the results varied. While of failed attempts (1.61%) to remove the MEDJUS compared with Farouk et al. found that MEDJUS elicited a higher pain score, [8–10,14] the traditional visualized double-J stent removal method. O’Kelly et al., Rassweiler et al., and Sevcenco et al. found MEDJUS Multiple reasons attributed to failed MEDJUS removal include diffi- to be significantly less painful than its conventional counter- [4,7,8,13] cult catheterization and structural difficulties such as trabeculated blad- parts. Kapoor et al. found little to no difference in the [8–10,13,14] [5] ders, stent encrustation, and severe prostate hypertrophy. In pain scores between them. However, MEDJUS could be associ- [8] these cases, where the removal of MEDJUS was unsuccessful, a conver- ated with higher rates of stent irritation. Furthermore, Farouk [8–10,13,14] sion to the use of standard cystoscopy was required. et al. showed higher morbidity with regard to urinary symptoms, work performance, and total USSQ score in those who had 4.1. Advantages MEDJUS inserted compared to those with double-J stents [7] The efficiency of MEDJUS allows for convenient stent removal in inserted. These factors need to be outweighed against the benefit [10] an out-patient setting, thus shortening patient waiting times. within each individual case. In addition, there are cost benefits as the cost for the procedure Within the pediatric cohort, Chalhoub et al. found insertion of and equipment used were much lower compared to the traditional the MEDJUS challenging, with a stent insertion failure rate of [4–8] double-J stent method. 16%. This rate was attributed to the decreased diameter of the The main advantage of MEDJUS over traditional double-J stents vesicoureteral junction in children, especially in those aged <5 seems to be cost-related. The cost of MEDJUS was lower than that years, and the diameter of the magnet (7 Fr) being larger than the of traditional double-J stents. This is attributed to the negation of diameter of the stent employed (4.5 Fr). However, 69% of the fail- admission for inpatient removal, despite the initial higher cost of ures occurred within the first third of the study period, which re- [4–8] MEDJUS compared to the traditional double-J cost. quired technique modifications that allowed for fewer subsequent [14] Other advantages to be considered regarding patient experience insertion failure attempts. include the duration of stent indwelling time, as well as the extrac- tion time. It was found that MEDJUS had a shorter stent duration 4.3. Tolerability, cost, limitations, and future directions [4,10] than the traditional double-J stents. This can be extended to All studies containing a cost analysis found cost benefits with [4–8] reduce opportunities for infections and other complications. Many MEDJUS insertion. The cost benefit with MEDJUS use is due factors allow for easier and more efficient extraction of MEDJUS, to the ability to mitigate fees for inpatient flexible cystoscopy re- such as extraction being an easier and less invasive procedure to moval, which requires a physician and other related procedural perform, primarily because it can be performed in an outpatient ca- fees. The proposed annual cost benefit, reported by Kapoor et al. pacity, as it does not require anesthesia to perform in the majority in 2020 at a deceased-donor renal transplant center, was approxi- [10] [5] of cases. As such, extraction times were also shorter, translating mately $27,360 CAD annually. to a shorter period of discomfort for the patient and a decreased Although newer single-use disposable ureteral stent-grasping cys- [5,8] risk of nosocomial infection. toscopic devices are becoming commonplace in modern urological [23] The use of MEDJUS within the transplant setting has been linked centers, along with a recent description of a self-constructed stent [14] [24] to an annual cost savings of CAD 27,360. Another advantage of grasper in cases of encrustation, the use of MEDJUS extraction is using such technology within the transplant setting is the faster ex- a rather simplified alternative. [10,14] traction time of ureteric stents. Adding to this, there was no dif- Future studies could examine the use of MEDJUS and its out- ference in the use of magnetic ureteric stents within the transplant comes in the more challenging socio-economic regions and during setting when comparing the discomfort, infection, and complication mobile regional endourology services. The suggested cost benefit [14] rates. may be exaggerated in regions with inadequate resources or the ab- Within the recent COVID-19 setting, the advantages of MEDJUS sence of an established health system. are attractive in mitigating the potential spread. Reducing the need The performance of a meta-analysis was precluded in this sys- for inpatient removal and hospital stay not only reduces potential tematic review because the cohort studies were performed at differ- risk but also reduces added costs with regard to staff and theater seg- ent centers within different regions, where surgeons used various regation, personal protective equipment, mandatory testing, and periods for extraction. sanitization. Furthermore, the decreased need for inpatient removal allows for better allocation of hospital resources during the pandemic. 5. Conclusions 4.2. Disadvantages In general, magnetic devices are contraindicated in the presence of Ureteric stenting is a common and important urological procedure, [2,3] cardiac pacemakers, MRI studies, or other battery-operated de- of which many innovations and advances have been made. Ure- vices that may be in close proximity to the pelvis. They are also teric stenting still presents some challenges, many arising because [2,3] not beneficial in cases in which a repeat anesthetic or subsequent of the potentially invasive nature of the procedure. ureteroscopy is planned, as the conventional stent will be removed Guidelines and clinical judgements on the appropriate time and ap- under the anesthetic procedure in any event. As shorter indwelling propriate stenting methods remain contentious, and an individualized times are recommended for magnetic stents, these stents cannot be contextual approach is advised. The recommended indwelling period utilized as a long-term stent option. was 28?days of indwelling time. This needs to be considered when Failure of stent removal is another disadvantage of the magnetic considering MEDJUS usage. stent method. Rassweiler et al. and Mitchell et al. found that Because of the popularity and availability of stenting modalities MEDJUS failed to be removed more often than traditional such as magnetic ureteric stenting, further research will highlight 98 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org the usefulness of this innovative modality. Based on this review, [8] Rassweiler MC, Michel MS, Ritter M, Honeck P. Magnetic ureteral stent removal without cystoscopy: A randomized controlled trial. JEndourol MEDJUS aims to provide cost and pain benefits compared to the 2017;31(8):762–766. traditional double-J stent method. [9] Capocasale E, Cremaschi E, Valle RD, et al. Implementing a ureteric magnetic stent in the kidney transplant setting: Report of 100 consecutive Acknowledgments cases. Transplantation 2019;103(12):2654–2656. [10] Mitchell A, Bolduc S, Moore K, Cook A, Fermin C, Weber B. Use of a magnetic double J stent in pediatric patients: A case-control study at two We are indebted to Mr Devind Peter (Wits Health Sciences Library, Canadian pediatric centers. J Pediatr Surg 2020;55(3):486–489. University of the Witwatersrand, Johannesburg, South Africa) for [11] Macaluso JN, Deutsch JS, Goodman JR, Appell RA, Prats LJ, Wahl P. The his kind assistance in the literature retrieval process. use of the magnetip double-J ureteral stent in urological practice. JUrol 1989;142(3):701–703. Statement of ethics [12] CASP Checklists – CASP – Critical Appraisal Skills Programme. Available at: https://casp-uk.net/casp-tools-checklists/. Accessed October 11, 2020. [13] Sevcenco S, Eredics K, Lusuardi L, Klingler HC. Evaluation of pain The local institutional ethics waiver was obtained, with approval perception associated with use of the magnetic-end ureteric double-J stent certificate No: W-CBP-210504–01 (2021). for short-term ureteric stenting. World J Urol 2018;36(3):475–479. [14] Chalhoub M, Kohaut J, Vinit N, et al. Feasibility and safety of Conflict of interest statement magnetic-end double-J ureteral stent insertion and removal in children. WorldJUrol 2020;39(5):1649–1655. [15] NCT03143556. Black Star – Magnetic Stent Removal in Transplant The authors report that they have no conflicts of interest. This re- Patients. Available at: https://clinicaltrials.gov/show/NCT03143556. Accessed view was an impartial, independent, nonremunerative, and critical April 20, 2021. appraisal of the relevant literature. [16] NCT04582019. Evaluation of Safety and Effectiveness of Ureteral DJ Stent with Magnet. Available at: https://clinicaltrials.gov/show/NCT04582019. Accessed April 20, 2021. Funding source [17] NCT03257306. Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS). Available None. at: https://clinicaltrials.gov/show/NCT03257306. Accessed April 20, 2021. [18] Ozturk H. Facilitate stent removal: Magnetic DJ stent. Urol Case Rep Author contributions 2017;11:55–56. [19] Pieragostini R, Cauchetier E, Oro H, et al. 2SPD-003 magnetic double pigtail stent: An economically interesting innovative device? Eur J Hosp All authors contributed equally in this study. Pharm 2018;25:A11. [20] Akerman J, Vasisth G, Tajzler C, et al. Comparison of cystoscopic versus References magnetic retrieval device for removal of ureteral stents in renal transplant patients: A randomized pilot study. JUrol 2018;199(4S):e550–e550. [1] Oliver R, Wells H, Traxer O, et al. Ureteric stents on extraction strings: A [21] Vasisth G, Akerman J, Hassan F, et al. Comparison of cystoscopic vs. systematic review of literature. Urolithiasis 2018;46(2):129–136. magnetic retrieval device for removal of ureteral stents in renal transplant [2] Mosayyebi A, Manes C, Carugo D, Somani BK. Advances in ureteral stent patients: A randomized pilot study. Can Urol Assoc J 2018;12(6):S98. design and materials. Curr Urol Rep 2018;19(5):35. [22] Sallusto F, Rischmann P, Prudhomme T, et al. Magnetic Black-Star® [3] Forbes C, Scotland KB, Lange D, Chew BH. Innovations in ureteral stent double J stent in kidney transplantation: Is it worthy? Eur Urol Suppl technology. Urol Clin North Am 2019;46(2):245–255. 2019;18(1):e1032. [4] O’Kelly JA, Haroon UM, Rauf AJ, et al. Ureteric stenting with magnetic [23] Adam A, Lawrentschuk N, Bhattu AS, Nagdee J. Efficacy of the novel, retrieval: An alternative to traditional methods. Ir J Med Sci 2020;189(1): innovative, single-use grasper integrated flexible cystoscope for ureteral 289–293. stent removal: A systematic review. ANZ J Surg 2021;91(12):2599–2605. [5] Kapoor A, Akerman J, Wong ECL, et al. Comparison of a magnetic [24] Adam A, Bhattu AS, Lawrentschuk N. Trans-urethral snare stent removal: retrieval device vs. flexible cystoscopy for removal of ureteral stents in A novel, self-constructed innovation for simultaneous ureteral stent renal transplant patients: A randomized controlled trial. Can Urol Assoc removal and safety guidewire insertion. ANZ J Surg 2021;91(4):571–577. J 2020;15(2):E97–E102. [6] Pohlmann PF, Kunzelmann M, Wilhelm K, et al. Magnetic ureteral stents are feasible in kidney transplant recipients: A single-center experience. Int J Organ Transplant Med 2019;10(4):162–166. How to cite this article: Damodaran V, Els B, Daras E, Kataka T, [7] Farouk A, Tawfick A, Hasan M, Abuftira AA, Maged WA. Can magnitip Gulamali SS, Ntakana S, Perera M, Adam A. The “ins and outs” of the double-J stent serve as a substitute for a standard double-J stent? Turkish J magnetic ureteral stent: A novel innovation in Endourology. Curr Urol Urol 2019;45(6):437–443. 2023;17(2):92–99. doi: 10.1097/CU9.0000000000000104 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Current Urology Wolters Kluwer Health

The “ins and outs” of the magnetic ureteral stent: A novel innovation in Endourology

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Abstract

Background: Ureteral stents play a major role in maintaining ureteral patency. Various innovations are advocated in the design and sub- sequent removal of traditional double-J ureteral stents, such as the magnetic-end double-J ureteral stent (MEDJUS). This stent facili- tates outpatient removal using a magnetic stent removal device. This systematic review was conducted to analyze the published role, efficacy, and outcomes of MEDJUS. Materials and methods: After PROSPERO registration (CRD42021235739), an electronic database search (PubMed, EMBASE, Cochrane Library, Scopus, and Web of Science) was performed on December 31, 2020. The search terms were as follows: “magnetic,” “ureteric,”“stent,” “double-J,” “urotech,” and “Black-Star.” Results: Nine studies with a total of 685 patients were included in the systematic review. The total number of MEDJUS procedures used was 498 (73%) compared to the 187 (27%) traditional double-J stent method. Magnetic-end double-J ureteral stent extraction failure was reported in 8 cases (1.61%). Compared with traditional stents, MEDJUS showed a cost benefit in 5/5 studies. Better pain scores (during stent in situ) and (at stent removal) were observed in 2/3 and 3/4 of the studies, respectively. Conclusions: Magnetic-end double-J ureteral stent may serve as a viable alternative to traditional double-J stents, offering cost and pain benefits with similar rates of complications. Magnetic-end double-J ureteral stent also offers relative ease of extraction and a re- duced need for inpatient removal. This ambulatory stent removal technique has forged its use in modern urological practice. Keywords: Double-J; Innovation; Magnetic stentMagnetic stent; Stent removal 1. Introduction Ureteral stents are removed either using cystoscopy in an out- patient setting or in the operating theatre. These procedures consequently result in additional procedural costs, longer hospi- Ureteric stenting is a common urological procedure that is used to tal stay, and patient discomfort, with symptoms such as pain, he- maintain ureteral patency. Stenting is effective in ureteral obstruc- [5] maturia, and lower urinary tract symptoms. Fortunately, recent tion, in which the lack of optimal surgical decompression of the innovations in stent material, properties, and design are all aimed urinary tract can lead to urinary tract infection (UTI), renal insuf- [1–6] at reducing the disadvantages of traditional ureteric stent removal, ficiency, or even renal failure. [6,8,9] as well as reducing stent-related complications. One innovation Stent insertion may also be performed prophylactically to mitigate has been the use of magnetic-end double-J ureteral stent (MEDJUS), the risk of ureteric obstruction, stricture formation, and colic symp- which can be removed by using a magnetic retrieval device in an out- toms, following various urological and nonurological procedures. patient setting. The rationale behind the creation and use of mag- Prolonged ureteric stent insertion has been linked to bacterial netic stents is to avoid the need for cystoscopy when removing ure- colonization and encrustation, leading to UTI, obstruction, and teric stents, and many versions of MEDJUS have been attempted [2,3] lower urinary tract symptoms. early stent removal is the most over the past decade. Previous attempts have led to dissatisfaction [7] important factor for preventing unwanted complications. and serious safety concerns. However, recent developments have demonstrated improved safety, feasibility, and patient satisfaction [10,11] for clinical use. *Corresponding Author: Ahmed Adam, Division of Urology, Department of Surgery, The novel, innovative, magnetic double-J ureteral stent (Blackstar, Faculty of Health Sciences, University of the Witwatersrand, 7 York Road, Parktown, Urotech [Achenmühle, Germany]) is made of polyurethane and has Johannesburg 2193, South Africa. E-mail address: aadam81@gmail.com (A. Adam). a cylindrical magnet attached to the distal stent coil (Fig. 1). The Current Urology, (2023) 17, 2, 92–99 magnet was attached via a looped string knotted to the distal stent. Received February 10, 2022; Accepted May 24, 2022. The removal device was a Tiemann tip 30°-angulated device con- http://dx.doi.org/10.1097/CU9.0000000000000104 structed from soft polyurethane. The midline yellow line demarcates Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. This the center or midline region of the removal device to allow orienta- is an open-access article distributed under the terms of the Creative Commons tion of the surgeon. This angulated tip allows easy navigation Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it through the male urethra and lateral deviation once inside the is permissible to download and share the work provided it is properly cited. The bladder, to attract the cylindrical magnetic bead attached to the work cannot be changed in any way or used commercially without permission [8] from the journal. distal stent coil. 92 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Figure 1. Magnetic double-J ureteral stent (Urotech Black-Star). Photographic image of the magnetic double-J ureteral stent (Urotech Black-Star) depictingthe following: (A) Magnetic distal stent coil (26 cm length/2 mm diameter) and magnetic retrieval device (40 cm length/5 mm diameter); (B) Magnetic retrieval device approaching the magnetic bead tied to the distal stent coil; (C) Magnetic attraction with an “audible click”; (D) A steady pull allows stent retrieval. Given such developments regarding MEDJUS use, this systematic 2.4. Study quality and checklist review was conducted to critically appraise the published efficacy, The Critical Appraisal Skills Program (2018) Oxford (Cohort [12] cost-saving aspects, pain response, symptomatology, indwelling dura- Study) Checklist, was used to assess the underlying study qual- tion, extraction failure, and general outcomes related to MEDJUS use. ity within the studies appraised. 2. Materials and methods 3. Results 2.1. Search strategy In total, 17 related studies were identified. After screening for eligi- After PROSPERO registration was attained (certificate no.: bility, relevance, and relatedness, 9 studies were included for ap- [4–10,13,14] CRD42021235739), an electronic database search (PubMed, praisal (Fig. 2). These 9 studies included 3 retrospective [5,9,10] [4,8,14] EMBASE, Cochrane Library, Scopus, and Web of Science) was studies, 3 randomized control trials, 2 prospective [6,13] [7] performed on December 31, 2020. The following search terms were uti- studies, and 1 case-control study. The 8 excluded articles [15–17] [18] lized: “MEDJUS,”“ureteric,”“stent,”“double-J,”“urotech,” and consisted of 3 ongoing clinical trials, 1 case report, 1cost [19] “Black-Star.” These terms were combined using Boolean operators evaluation, 2 papers were updated pilot studies from the same [20,21] [22] (AND and OR) to refine the search. Articles retrieved underwent cita- authors, and 1 conference abstract (Table 1). tion and reference review to further identify any missed relevant or re- lated studies. This study received local institutional ethics certification 3.1. Appraised studies and patient demographics (W-CBP-210504–01). The 9 included studies (Table 1) had a combined total of 685 pa- tients. Eight studies recorded the sex of the patients, with Mitchell [10] 2.2. Inclusion and exclusion criteria et al. being the only study not documenting this variable. The The inclusion criteria were full-text articles and reports on the use results of the studies that documented the sex showed a male pre- of magnetic ureteric stents. The types of articles included pediatric, dominance (458 male vs. 147 female), with a male:female ratio clinical comparative, nonclinical comparative, and cost evaluation/ of 3:1 (Table 2). The total number of MEDJUS procedures used comparison studies. Case reports, abstracts only, conference pro- was 498 (73%) compared to the 187 (27%) traditional double-J ceedings, cost-only comparisons, nonmagnetic stents, and pilot stent method. Two studies involved a pediatric cohort assessing studies were excluded from this review. MEDJUS stent usage in 164 children (80 and 84 children, [10,14] respectively). 2.3. Data extraction Studies that met the inclusion criteria were assessed in the journal of 3.2. Pain response and tolerance [4–9,13,14] publication, period of review, study type, geographic region, number Eight studies assessed pain associated with MEDJUS use. of patients, demographic details, associated pain, complications, uri- Pain scoring was assessed using the Ureteral Stent Symptom Ques- [4,5,7] nary symptoms, adverse events, stent extraction failure, and reported tionnaire (USSQ) alone in 3 studies, using the Visual Analog [9,13] cost benefits. The extracted data were filtered into raw numbers either Scale for pain in 2 studies, and 2 studies assessed pain using from the conversion of a percentage of the study group or directly. both the USSQ and Visual Analog Scale pain assessment tools 93 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Figure 2. PRISMA flow diagram summarizing literature review. [6,8] (Table 4). Chaloub et al. assessed pain without using any of benefit per case with MEDJUS use compared to traditional [14] these assessment tools. The average pain score for the MEDJUS double-J stent use. All studies reported cost benefits across 4 coun- [4,6,8] [7] [5] (stent in situ) was 2.46, compared with 2.94 for the traditional tries, 3 being European, 1African, and 1 North American [5,6,8,13] double-J stent. Similarly, the average pain score for stent re- (Table 4). moval was lower within the MEDJUS group compared with the tra- [4–6,8,13,14] ditional double-J stent group: 2.78 and 4.03, respectively. 3.5. Complications Two studies found that postoperative morbidity related to MEDJUS The most common complication found in 4 studies was sporadic [7,8] use was significant. However, two other studies reported that infection. Mitchell et al. and O’Kelly et al. reported a single case [4,5] [4,10] postoperative morbidity was not statistically significant. each with complicated UTI and fever requiring hospitalization. In addition, Chalhoub et al. reported that 5 children were treated [14] 3.3. Stent indwelling time, extraction time and failure of with oral antibiotics for febrile UTI. Thus, the total reported removal MEDJUS-related UTI incidence was 7 cases in this review. When assessing the published data regarding the cumulative 685 Two studies noted a single case of stent encrustation due to pro- patients (514 MEDJUS:187 conventional stents), extraction time longed indwelling time secondary to postoperative anastomotic [5,8] ranges were acceptable, with an overall extraction failure in only leaks and postoperative laparoscopic pyeloplasty. 8 instances (1.61%) (Table 3). Another study highlighted a marginal increase in stent irritation in the MEDJUS group compared with the traditional double-J [13] 3.4. Cost stent group. However, no significant differences in stent irrita- Five studies incorporated a cost analysis, comparing MEDJUS to tion were found in the cohort of patients carrying and indwelling [4–8] [13] the traditional double-J stent. All 5 studies reported a cost stents for 4 weeks (Table 4). 94 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Table 1 Summary of articles assessing magnetic ureteric stent use. Author Ref Study type Journal Year Period of review Country Study content Comparator Authors’ conclusions Rassweiler et al., 2017 [8] Prospective RCT J Endourol 2017 Oct 2013–Oct 2014 Germany Evaluate and compare the magnetic USSQ,VAS,removal time, The discomfort caused by the indwelling magnetic DJ stents to a standard DJ regarding cost analysis DJ is comparable to the standard DJ. However, quality of life with indwelling DJs as well the magnetic DJ-removal is less painful and as discomfort during the removal. faster. Sevcenco et al., 2018 [12] Prospective World J Urol 2017 Nov 2013–July 2015 Germany Assessment of the morbidity, complication VAS, urine culture result, The magnetic-end ureteric double-J stent is a safe rate, and pain perception during removal renal ultrasonogram option associated with less pain, particularly for of a novel ureteric stent with a magnetic male patients requiring short-term ureteric stenting. end using a-traumatic retrieval catheter. Pohlmann et al., 2019 [6] Prospective Int J Organ 2019 - Germany Assessment of the functional efficacy and feasibility USSQ,VAS,removal time, Using magnetic ureteral stents is a feasible option Transplant Med of magnetic DJ stents in kidney transplant cost analysis for living donation AB0-identical kidney recipients. transplant recipients. Farouk et al., 2019 [7] Prospective RCT Turk J Urol 2019 Dec 2018–Mar 2019 Egypt To evaluate and compare the morbidity of the USSQ, procedure cost, The morbidity caused by the magnetic DJ was magnetic stent to the standard stent and application, retrieval found to be higher. However, the removal of evaluate the possibility of retrieving the magnetic accuracy, and discomfort the magnetic DJ was less costly than the tip of the DJ stent without cystoscopy. standard DJ. Capocasale et al., 2019 [9] Retrospective Transplantation 2019 Apr 2015–Sept 2018 Italy Analysis of magnetic ureteric stents in Extraction time, VAS pain, Magnetic stents appeared to be safe and analysis 100 consecutive kidney transplants adverse events cost-effective. They should be implemented in kidney transplant reciepients O’Kelly et al., 2020 [4] Retrospective Ir J Med Sci 2020 Sept 2016–July 2017 Ireland Comparison of magnetic stent and standard USSQ, stent duration, pain Magnetic stents cause similar morbidity compared analysis ureteric stents with regard to morbidity, pain on on stent removal, cost with standard stents removed by flexible stent removal and cost-effectiveness. analysis, complications cystoscopy; they are associated with less pain at removal and are cost saving. Kapoor et al., 2020 [5] Prospective RCT Can Urol Assoc J 2020 May 2017–Apr 2018 Canada Comparison of clinical and cost-related outcomes USSQ, clinical, procedural, Black-Star® stent was well-tolerated when of conventional and magnetic stents in patients and cost outcomes, stent compared to the conventional stent and is undergoing deceased donor renal removal potentially cost-saving transplantation. Mitchell et al., 2020 [10] Case-control J Pediatr Surg 2020 May 2017–May 2018 Canada Demonstration of the safety and efficacy of Stent Duration, retrieval Magnetic stents represent a safe and effective study magnetic stents in pediatric patients. alternative to traditional stents, especially in a pediatric patient. Chalhoub et al., 2020 [14] Retrospective World J Urol 2020 Nov 2016–Dec 2019 Germany Assessment of feasibility and safety of insertion Stent insertion, stent removal, The use of a MEDJUS is a safe and effective analysis and removal of a MEDJUS in a pediatric pain score, urinary solution for ureteral stenting without exposing population. symptoms children to additional GA. DJ = double-J; GA = general anesthesia; MEDJUS = magnetic-end double-J ureteral stent; RCT = randomized controlled trial; USSQ = Ureteric Stent Symptom Questionnaire; VAS = Visual Analog Scale. Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Table 2 Summary of patient demographics (journals listed in order of publication). Author Ref No. of patients Male: Female Mean age (range) Magnetic stent: Traditional stent Rassweiler et al., 2017 [8] 60 47:13 47.5 (23–75) 40:20 Sevcenco et al., 2018 [12] 163 151:12 50.5 130:33 Pohlmann et al., 2019 [6] 7 3:4 48.7 7:0 Farouk et al., 2019 [7] 50 35:15 31.08 (19–50) 25:25 Capocasale et al., 2019 [9] 100 65:35 - (22–74) 100:0 O’Kelly et al., 2020 [4] 100 73:27 48.7 50:50 Kapoor et al., 2020 [5] 41 27:14 60.41 22:19 Mitchell et al., 2020 [10] 80 - 5.3 40:40 Chalhoub et al., 2020 [14] 84 57:27 7.8 (0.5–18) 84:0 Total 685 3:1 498:187 3.6. Pediatric experience multitude of complications during the stent indwelling period [7,14] Mitchell et al. reported 1 case of UTI and 1 case of magnetic stent and subsequent removal. insertion failure among 40 pediatric cases. They recommended Alternative stents such as MEDJUS have been introduced to alle- passing the magnetic stent in a prograde fashion in children aged viate these complications in patients. The following variables were [10] <2 years undergoing pyeloplasty. assessed: geographical location, demographics, stent dwell time, Chalhoub et al. attempted MEDJUS in 100 children, with stent stent extraction time, number of failed stent removals, cost benefit, insertion performed in a retrograde, anterograde, and open fash- pain score, postoperative mobility, and urinary symptoms (Table 1). ion. All stent insertion failures 16/100 occurred in an anterograde Various geographical regions were represented, with most stud- manner during laparoscopic pyeloplasty. Stent insertion was suc- ies being European, 1 study by Farouk et al. conducted in Egypt, cessfully performed in 84/100 cases assessed. There were 2/100 and 2 studies conducted in Canada by Kapoor et al. and Mitchell [5,7,10] stent removal failures occurred in cases in which the magnetic et al. The feasibility of conducting such studies in the afore- [14] bead was unreachable within the bladder diverticulum. mentioned regions may be explained by established resource accessi- bility and advanced healthcare systems. However, there is a no- 3.7. Quality of the studies assessed ticeable paucity of literature regarding MEDJUS within poorer When assessing the quality grading of the articles selected using the socio-economic global regions, and as such, further research is re- [12] Critical Appraisal Skills Program (Oxford) system, 6cohort quired to adequately assess the utility thereof in such settings. studies (Table 5) and 3 randomized control trial studies (Table 6) The male predominance in the review may be a confounding scored favorably. variable for many factors assessed in the review. Nonetheless, MEDJUS use revealed lower pain scores upon removal of the MEDJUS stents compared to the use of the double-J ureteral [4,6,8,13] 4. Discussion stent. Prolonged stent dwell time has been associated with adverse ef- [4,8–10] Traditional double-J ureteral stents are commonly used to main- fects, such as infections and stent encrustation. Thus the [10] tain ureteral patency; however, they have been associated with a MEDJUS stent indwelling time of 28?days is advocated. Table 3 Summary of articles assessing stent dwell time, extraction time, and failure of removal. Mean stent duration (d) Mean extraction time (min) Mean extraction time (min) Reference Magnetic Traditional Magnetic Traditional Magnetic Traditional number stent stent stent stent stent stent Rassweiler et al., 2017 [8] - - 9.55 including 21.35 1 (2.5%) 0 the cleaning time Sevcenco et al., 2018 [12] 7.0 28.0 7.0 (no -- 1(0.7%) - (additional additional cohort) cohort) Pohlmann et al., 2019 [6] 30.0 - 3.4 - 0 - Farouk et al., 2019 [7] - - - - 0 0 Capocasale et al., 2019 [9] - - 83 (83%): <0.5 - 2 (2.0%) - 15 (15%): 0.5-3 O’Kelly et al., 2020 [4] 5.5 21.5 - - 0 0 Kapoor et al., 2020 [5] - - 4.8 6.67 1 (4.5%) - Mitchell et al., 2020 [10] 36.8 48.8 - - 1 (2.5%) 0 Chalhoub et al., 2020 [14] - - 4.0 - 2 (2.4%) - Total 8(1.61%) 96 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org Table 4 Summary of cost benefit, pain scores, postoperative morbidity and urinary symptoms. Mean pain score (stent in situ) Mean pain score (stent removal) Reference Magnetic Traditional Magnetic Traditional Postoperative Urinary number Cost benefit stent stent stent stent morbidity (USSQ) symptoms Rassweiler et al., 2017 [8] €101.41 3.00 5.00 3.00 4.00 Significant - Sevcenco et al., 2018 [12] Not given 2.42 2.15 2.17 5.88 - - Capocasale et al., 2019 [9] Not given - - - - - - Farouk et al., 2019 [7] 1156 LE - - - - Significant Significant Pohlmann et al., 2019 [6] €130 2.67 - 2.60 - - - Chalhoub et al., 2020 [14] Not given - - 3.00 - - - Kapoor et al., 2020 [5] $304.02 CAD 1.75 1.68 3.00 2.33 Not significant Not significant Mitchell et al., 2020 [10] Not given - - - - - - O’Kelly et al., 2020 [4] €203 - - 2.90 3.90 Not significant Not significant $ = US Dollar; € = Euro; CAD = Canadian Dollar; LE = Egyptian pound; USSQ = Ureteric Stent Symptom Questionnaire. Table 5 Details of the Critical Appraisal Skills Program tool used to assess cohort studies included for review. O’Kelly Pohlmann Capocasale Mitchell Sevcenco Chalhoub et al., 2020 et al., 2019 et al., 2019 et al., 2020 et al., 2018 et al., 2020 Reference number [4] [6] [9] [10] [12] [14] Did the study address a clearly focused issue? Y Y Y Y Y Y Was the cohort recruited in an acceptable way? Y N Y Y Y Y Was the exposure accurately measured to minimize bias? Y Y Y N Y Y Was the outcome accurately measured to minimize bias? Y Y Y Y Y Y Have the authors listed all confounding factors? Y Y CT Y Y CT Have the authors taken account of all the confounding factors? Y Y CT Y Y N Was the follow-up complete enough? CT Y Y CT Y Y Was the follow-up long enough? CT Y Y CT Y Y Do you believe the results? Y Y Y Y Y Y Can the results be applied to a local population? Y N Y Y Y Y Do the results of the study fit with other available evidence? Y Y Y Y Y Y CT = cannot tell; N = no; Y = yes. Table 6 Details of the Critical Appraisal Skills Program tool used to assess randomized control trial studies included for review. Kapoor Farouk Rassweiler et al., 2020 et al., 2019 et al., 2017 Reference number [5] [7] [8] Did the study address a clearly focused research question? Y Y Y Was the assignment of participants to intervention randomized? Y Y Y Were all participants who entered the study accounted for at its conclusion? Y Y Y Were the participants blind to the intervention they were given? N N Y Were the investigators blind to the intervention they were giving to participants? N N N Were the people assessing/analyzing the outcomes blinded? N N N Were the study groups similar at the start of the randomized controlled trial? Y Y Y Apart from the experimental intervention, did each study group receive the same level of care? Y Y Y Were the effects of intervention reported comprehensively? Y Y Y Was the precision of the estimate of the intervention or treatment effect reported? N Y Y Do the benefits of the experimental intervention outweigh the harms and costs? Y Y Y Can the results be applied to your local population/in your context? Y Y Y Would the experimental intervention provide greater value to the people in your care than any of the existing interventions? Y Y Y CT = cannot tell; N = no; Y = yes. 97 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org [8,10] External factors due to delays in stent removal were accounted for double-J stents; however, this difference was marginal. Farouk [6,10] within the studies by Mitchell et al. and Pohlmann et al. et al. and O’Kelly et al. found no evidence of failed removal in ei- [4,7] Assessing the time taken to extract the MEDJUS and magnetic ther the MEDJUS or traditional double-J stent groups. stent removals were more efficient than traditional double-J stent A potential disadvantage is the relative pain experienced by pa- removals. However, there was a marginal increase in the number tients. This point is worth noting; however, the results varied. While of failed attempts (1.61%) to remove the MEDJUS compared with Farouk et al. found that MEDJUS elicited a higher pain score, [8–10,14] the traditional visualized double-J stent removal method. O’Kelly et al., Rassweiler et al., and Sevcenco et al. found MEDJUS Multiple reasons attributed to failed MEDJUS removal include diffi- to be significantly less painful than its conventional counter- [4,7,8,13] cult catheterization and structural difficulties such as trabeculated blad- parts. Kapoor et al. found little to no difference in the [8–10,13,14] [5] ders, stent encrustation, and severe prostate hypertrophy. In pain scores between them. However, MEDJUS could be associ- [8] these cases, where the removal of MEDJUS was unsuccessful, a conver- ated with higher rates of stent irritation. Furthermore, Farouk [8–10,13,14] sion to the use of standard cystoscopy was required. et al. showed higher morbidity with regard to urinary symptoms, work performance, and total USSQ score in those who had 4.1. Advantages MEDJUS inserted compared to those with double-J stents [7] The efficiency of MEDJUS allows for convenient stent removal in inserted. These factors need to be outweighed against the benefit [10] an out-patient setting, thus shortening patient waiting times. within each individual case. In addition, there are cost benefits as the cost for the procedure Within the pediatric cohort, Chalhoub et al. found insertion of and equipment used were much lower compared to the traditional the MEDJUS challenging, with a stent insertion failure rate of [4–8] double-J stent method. 16%. This rate was attributed to the decreased diameter of the The main advantage of MEDJUS over traditional double-J stents vesicoureteral junction in children, especially in those aged <5 seems to be cost-related. The cost of MEDJUS was lower than that years, and the diameter of the magnet (7 Fr) being larger than the of traditional double-J stents. This is attributed to the negation of diameter of the stent employed (4.5 Fr). However, 69% of the fail- admission for inpatient removal, despite the initial higher cost of ures occurred within the first third of the study period, which re- [4–8] MEDJUS compared to the traditional double-J cost. quired technique modifications that allowed for fewer subsequent [14] Other advantages to be considered regarding patient experience insertion failure attempts. include the duration of stent indwelling time, as well as the extrac- tion time. It was found that MEDJUS had a shorter stent duration 4.3. Tolerability, cost, limitations, and future directions [4,10] than the traditional double-J stents. This can be extended to All studies containing a cost analysis found cost benefits with [4–8] reduce opportunities for infections and other complications. Many MEDJUS insertion. The cost benefit with MEDJUS use is due factors allow for easier and more efficient extraction of MEDJUS, to the ability to mitigate fees for inpatient flexible cystoscopy re- such as extraction being an easier and less invasive procedure to moval, which requires a physician and other related procedural perform, primarily because it can be performed in an outpatient ca- fees. The proposed annual cost benefit, reported by Kapoor et al. pacity, as it does not require anesthesia to perform in the majority in 2020 at a deceased-donor renal transplant center, was approxi- [10] [5] of cases. As such, extraction times were also shorter, translating mately $27,360 CAD annually. to a shorter period of discomfort for the patient and a decreased Although newer single-use disposable ureteral stent-grasping cys- [5,8] risk of nosocomial infection. toscopic devices are becoming commonplace in modern urological [23] The use of MEDJUS within the transplant setting has been linked centers, along with a recent description of a self-constructed stent [14] [24] to an annual cost savings of CAD 27,360. Another advantage of grasper in cases of encrustation, the use of MEDJUS extraction is using such technology within the transplant setting is the faster ex- a rather simplified alternative. [10,14] traction time of ureteric stents. Adding to this, there was no dif- Future studies could examine the use of MEDJUS and its out- ference in the use of magnetic ureteric stents within the transplant comes in the more challenging socio-economic regions and during setting when comparing the discomfort, infection, and complication mobile regional endourology services. The suggested cost benefit [14] rates. may be exaggerated in regions with inadequate resources or the ab- Within the recent COVID-19 setting, the advantages of MEDJUS sence of an established health system. are attractive in mitigating the potential spread. Reducing the need The performance of a meta-analysis was precluded in this sys- for inpatient removal and hospital stay not only reduces potential tematic review because the cohort studies were performed at differ- risk but also reduces added costs with regard to staff and theater seg- ent centers within different regions, where surgeons used various regation, personal protective equipment, mandatory testing, and periods for extraction. sanitization. Furthermore, the decreased need for inpatient removal allows for better allocation of hospital resources during the pandemic. 5. Conclusions 4.2. Disadvantages In general, magnetic devices are contraindicated in the presence of Ureteric stenting is a common and important urological procedure, [2,3] cardiac pacemakers, MRI studies, or other battery-operated de- of which many innovations and advances have been made. Ure- vices that may be in close proximity to the pelvis. They are also teric stenting still presents some challenges, many arising because [2,3] not beneficial in cases in which a repeat anesthetic or subsequent of the potentially invasive nature of the procedure. ureteroscopy is planned, as the conventional stent will be removed Guidelines and clinical judgements on the appropriate time and ap- under the anesthetic procedure in any event. As shorter indwelling propriate stenting methods remain contentious, and an individualized times are recommended for magnetic stents, these stents cannot be contextual approach is advised. The recommended indwelling period utilized as a long-term stent option. was 28?days of indwelling time. This needs to be considered when Failure of stent removal is another disadvantage of the magnetic considering MEDJUS usage. stent method. Rassweiler et al. and Mitchell et al. found that Because of the popularity and availability of stenting modalities MEDJUS failed to be removed more often than traditional such as magnetic ureteric stenting, further research will highlight 98 Damodaran et al.  Volume 17  Issue 2  2023 www.currurol.org the usefulness of this innovative modality. Based on this review, [8] Rassweiler MC, Michel MS, Ritter M, Honeck P. Magnetic ureteral stent removal without cystoscopy: A randomized controlled trial. JEndourol MEDJUS aims to provide cost and pain benefits compared to the 2017;31(8):762–766. traditional double-J stent method. [9] Capocasale E, Cremaschi E, Valle RD, et al. Implementing a ureteric magnetic stent in the kidney transplant setting: Report of 100 consecutive Acknowledgments cases. Transplantation 2019;103(12):2654–2656. [10] Mitchell A, Bolduc S, Moore K, Cook A, Fermin C, Weber B. Use of a magnetic double J stent in pediatric patients: A case-control study at two We are indebted to Mr Devind Peter (Wits Health Sciences Library, Canadian pediatric centers. J Pediatr Surg 2020;55(3):486–489. University of the Witwatersrand, Johannesburg, South Africa) for [11] Macaluso JN, Deutsch JS, Goodman JR, Appell RA, Prats LJ, Wahl P. The his kind assistance in the literature retrieval process. use of the magnetip double-J ureteral stent in urological practice. JUrol 1989;142(3):701–703. Statement of ethics [12] CASP Checklists – CASP – Critical Appraisal Skills Programme. Available at: https://casp-uk.net/casp-tools-checklists/. Accessed October 11, 2020. [13] Sevcenco S, Eredics K, Lusuardi L, Klingler HC. Evaluation of pain The local institutional ethics waiver was obtained, with approval perception associated with use of the magnetic-end ureteric double-J stent certificate No: W-CBP-210504–01 (2021). for short-term ureteric stenting. World J Urol 2018;36(3):475–479. [14] Chalhoub M, Kohaut J, Vinit N, et al. Feasibility and safety of Conflict of interest statement magnetic-end double-J ureteral stent insertion and removal in children. WorldJUrol 2020;39(5):1649–1655. [15] NCT03143556. Black Star – Magnetic Stent Removal in Transplant The authors report that they have no conflicts of interest. This re- Patients. Available at: https://clinicaltrials.gov/show/NCT03143556. Accessed view was an impartial, independent, nonremunerative, and critical April 20, 2021. appraisal of the relevant literature. [16] NCT04582019. Evaluation of Safety and Effectiveness of Ureteral DJ Stent with Magnet. Available at: https://clinicaltrials.gov/show/NCT04582019. Accessed April 20, 2021. Funding source [17] NCT03257306. Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS). Available None. at: https://clinicaltrials.gov/show/NCT03257306. Accessed April 20, 2021. [18] Ozturk H. Facilitate stent removal: Magnetic DJ stent. Urol Case Rep Author contributions 2017;11:55–56. [19] Pieragostini R, Cauchetier E, Oro H, et al. 2SPD-003 magnetic double pigtail stent: An economically interesting innovative device? Eur J Hosp All authors contributed equally in this study. Pharm 2018;25:A11. [20] Akerman J, Vasisth G, Tajzler C, et al. Comparison of cystoscopic versus References magnetic retrieval device for removal of ureteral stents in renal transplant patients: A randomized pilot study. JUrol 2018;199(4S):e550–e550. [1] Oliver R, Wells H, Traxer O, et al. Ureteric stents on extraction strings: A [21] Vasisth G, Akerman J, Hassan F, et al. Comparison of cystoscopic vs. systematic review of literature. Urolithiasis 2018;46(2):129–136. magnetic retrieval device for removal of ureteral stents in renal transplant [2] Mosayyebi A, Manes C, Carugo D, Somani BK. Advances in ureteral stent patients: A randomized pilot study. Can Urol Assoc J 2018;12(6):S98. design and materials. Curr Urol Rep 2018;19(5):35. [22] Sallusto F, Rischmann P, Prudhomme T, et al. Magnetic Black-Star® [3] Forbes C, Scotland KB, Lange D, Chew BH. Innovations in ureteral stent double J stent in kidney transplantation: Is it worthy? Eur Urol Suppl technology. Urol Clin North Am 2019;46(2):245–255. 2019;18(1):e1032. [4] O’Kelly JA, Haroon UM, Rauf AJ, et al. Ureteric stenting with magnetic [23] Adam A, Lawrentschuk N, Bhattu AS, Nagdee J. Efficacy of the novel, retrieval: An alternative to traditional methods. Ir J Med Sci 2020;189(1): innovative, single-use grasper integrated flexible cystoscope for ureteral 289–293. stent removal: A systematic review. ANZ J Surg 2021;91(12):2599–2605. [5] Kapoor A, Akerman J, Wong ECL, et al. Comparison of a magnetic [24] Adam A, Bhattu AS, Lawrentschuk N. Trans-urethral snare stent removal: retrieval device vs. flexible cystoscopy for removal of ureteral stents in A novel, self-constructed innovation for simultaneous ureteral stent renal transplant patients: A randomized controlled trial. Can Urol Assoc removal and safety guidewire insertion. ANZ J Surg 2021;91(4):571–577. J 2020;15(2):E97–E102. [6] Pohlmann PF, Kunzelmann M, Wilhelm K, et al. Magnetic ureteral stents are feasible in kidney transplant recipients: A single-center experience. Int J Organ Transplant Med 2019;10(4):162–166. How to cite this article: Damodaran V, Els B, Daras E, Kataka T, [7] Farouk A, Tawfick A, Hasan M, Abuftira AA, Maged WA. Can magnitip Gulamali SS, Ntakana S, Perera M, Adam A. The “ins and outs” of the double-J stent serve as a substitute for a standard double-J stent? Turkish J magnetic ureteral stent: A novel innovation in Endourology. Curr Urol Urol 2019;45(6):437–443. 2023;17(2):92–99. doi: 10.1097/CU9.0000000000000104

Journal

Current UrologyWolters Kluwer Health

Published: Jun 2, 2023

References