2007 Guideline for the Management of Ureteral Calculi

Abstract

You have accessJournal of UrologyAdult urology1 Dec 20072007 Guideline for the Management of Ureteral Calculi Glenn M. Preminger, Hans-Göran Tiselius, Dean G. Assimos, Peter Alken, Colin Buck, Michele Gallucci, Thomas Knoll, James E. Lingeman, Stephen Y. Nakada, Margaret Sue Pearle, Kemal Sarica, Christian Türk, and J. Stuart Wolf Glenn M. PremingerGlenn M. Preminger , Hans-Göran TiseliusHans-Göran Tiselius , Dean G. AssimosDean G. Assimos , Peter AlkenPeter Alken , Colin BuckColin Buck , Michele GallucciMichele Gallucci , Thomas KnollThomas Knoll , James E. LingemanJames E. Lingeman , Stephen Y. NakadaStephen Y. Nakada , Margaret Sue PearleMargaret Sue Pearle , Kemal SaricaKemal Sarica , Christian TürkChristian Türk , and J. Stuart WolfJ. Stuart Wolf View All Author Informationhttps://doi.org/10.1016/j.juro.2007.09.107AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction The American Urological Association Nephrolithiasis Clinical Guideline Panel was established in 1991. Since that time, the Panel has developed three guidelines on the management of nephrolithiasis, the most recent being a 2005 update of the original 1994 Report on the Management of Staghorn Calculi.1 The European Association of Urology began their nephrolithiasis guideline project in 2000, yielding the publication of Guidelines on Urolithiasis, with updates in 2001 and 2006.2 While both documents provide useful recommendations on the management of ureteral calculi, changes in shock-wave lithotripsy technology, endoscope design, intracorporeal lithotripsy techniques, and laparoscopic expertise have burgeoned over the past five to ten years. Under the sage leadership of the late Dr. Joseph W. Segura, the AUA Practice Guidelines Committee suggested to both the AUA and the EAU that they join efforts in developing the first set of internationally endorsed guidelines focusing on the changes introduced in ureteral stone management over the last decade. We therefore dedicate this report to the memory of Dr. Joseph W. Segura whose vision, integrity, and perseverance led to the establishment of the first international guideline project. This joint EAU/AUA Nephrolithiasis Guideline Panel (hereinafter the Panel) performed a systematic review of the English language literature published since 1997 and a comprehensively analyzed outcomes data from the identified studies. Based on their findings, the Panel concluded that when removal becomes necessary, SWL and ureteroscopy remain the two primary treatment modalities for the management of symptomatic ureteral calculi. Other treatments were reviewed, including medical expulsive therapy to facilitate spontaneous stone passage, percutaneous antegrade ureteroscopy, and laparoscopic and open surgical ureterolithotomy. In concurrence with the previously published guidelines of both organizations, open stone surgery is still considered a secondary treatment option. Blind basketing of ureteral calculi is not recommended. In addition, the Panel was able to provide some guidance regarding the management of pediatric patients with ureteral calculi. The Panel recognizes that some of the treatment modalities or procedures recommended in this document require access to modern equipment or presupposes a level of training and expertise not available to practitioners in many clinical centers. Those situations may require physicians and patients to resort to treatment alternatives. This article will be published simultaneously in European Urology and The Journal of Urology®. The Panel believes that future collaboration between the EAU and the AUA will serve to establish other internationally approved guidelines, offering physician and patient guidance worldwide. Methodology The Panel initially discussed the scope of the guideline and the methodology, which would be similar to that used in developing the previous AUA guideline. All treatments commonly employed in the United States and/or Europe were included in this report except for those that were explicitly excluded in the previous guideline or newer treatments for which insufficient literature existed. In the analysis, patient data were stratified by age (adult versus child), stone size, stone location, and stone composition. Later, however, the data were found to be insufficient to allow analysis by composition. The outcomes deemed by the Panel to be of particular interest to the patient included the following: stone-free rate, number of procedures performed, stone-passage rate or probability of spontaneous passage, and complications of treatment. The Panel did not examine economic effects, including treatment costs. Outcomes were stratified by stone location (proximal, mid, and distal ureter) and by stone size (dichotomized as ≤10 mm and >10 mm for surgical interventions, and ≤5 mm and >5 mm for medical interventions and observation where possible; exceptions were made when data were reported, for example as <10 mm and ≥10 mm). The mid ureter is the part of the ureter that overlies the bony pelvis, i.e., the position of the ureter that corresponds to the sacroiliac joint; the proximal ureter is above and the distal ureter is below. Treatments were divided into three broad groups: 1 Observation and medical therapy 2 Shock-wave lithotripsy and ureteroscopy 3 Open surgery, laparoscopic stone removal, or percutaneous antegrade ureteroscopy. The review of the evidence began with a literature search and data extraction. Articles were selected from a database of papers derived from MEDLINE® searches dealing with all forms of urinary tract stones. This database was maintained by a Panel chair. The abstract of each paper was independently reviewed by an American and a European Panel member, and articles were selected for data extraction if any panel member felt it might have useful data. Additional articles were suggested by Panel members or found as references in review articles. In total, 348 citations entered the extraction process. An American and a European Panel member each independently extracted data from each article onto a standardized form. The team members reconciled the extractions, and the data were entered into a Microsoft Access® (Microsoft, Redmond, WA) database. The Panel scrutinized the entries, reconciled the inconsistencies in recording, corrected the extraction errors, and excluded some articles from further analysis for the following reasons: 1 The article was included in the previous guideline. 2 The article did not provide usable data on the outcomes of interest. 3 Results for patients with ureteral stones could not be separated from results for those with renal stones. 4 The treatments used were not current or were not the focus of the analysis. 5 The article was a review article of data reported elsewhere. 6 The article dealt only with salvage therapy. A total of 244 of the 348 articles initially selected had extractable data. Articles excluded from evidence combination remained candidates for discussion in the text of the guideline. The goal was to generate outcomes tables comparing estimates of outcomes across treatment modalities. To generate an outcomes table, estimates of the probabilities and/or magnitudes of the outcomes are required for each intervention. Ideally, these are derived from a synthesis or combination of the evidence. Such a combination can be performed in a variety of ways depending on the nature and quality of the evidence. For this report, the Panel elected to use the Confidence Profile Method,3 which provides methods for analyzing data from studies that are not randomized controlled trials. The Fast*Pro computer software4 was used in the analysis. This program provides posterior distributions from meta-analyses from which the median can be used as a best estimate, and the central 95% of the distribution serves as a confidence interval. Statistical significance at the p <0.05 level (two-tailed) was inferred when zero was not included in the CI. Because of the paucity of controlled trials found on literature review, however, the outcome for each intervention was estimated by combining single arms from various clinical series. These clinical series frequently had very different outcomes, likely due to a combination of site-to-site variations in patient populations, in the performance of the intervention, in the skill of those performing the intervention, and different methods of determining stone-free status. Given these differences, a random-effects, or hierarchical, model was used to combine the studies. Evidence from the studies meeting the inclusion criteria and reporting a given outcome was combined within each treatment modality. Graphs showing the results for each modality were developed to demonstrate similarities and differences between treatments. The available data for procedures per patient would not permit a statistical analysis using these techniques. Unlike the binary outcome of stone-free status (the patient either is or is not stone free), the number of procedures per patient is a discrete rate. In some cases discrete rates can be approximated with a continuous rate, but in order to meta-analyze continuous rates, a measure of variance (e.g., standard deviation, standard error) is needed in addition to the mean. Unfortunately, measures of variance were rarely reported in the studies reviewed. As a result, numbers of procedures per patient were evaluated by calculating the average across studies weighted by the number of patients in each study. Procedures per patient were counted in three totals: primary procedures, secondary procedures, and adjunctive procedures. Primary procedures were all consecutive procedures of the same type aimed at removing the stone. Secondary procedures were all other procedures used to remove the stone. Adjunctive procedures were defined as additional procedures that do not involve active stone removal. One difficulty in estimating the total number of procedures per patient is that secondary and adjunctive procedures were not reported consistently. Since the Panel had decided to analyze primary, secondary, and adjunctive procedures separately, only studies that specifically reported data on a type of procedure were included in estimates for that procedure type. This approach may have overestimated numbers of secondary and adjunctive procedures because some articles may not have reported that procedures were not performed. It is important to note that, for certain outcomes, more data were reported for one or another treatment modality. While resulting CIs reflect available data, the probabilities for certain outcomes can vary widely within one treatment modality. In addition, the fact that data from only a few RCTs could be evaluated may have somewhat biased results. For example, differences in patient selection may have had more weight in analyses than differing treatment effects. Nevertheless, the results obtained reflect the best outcome estimates presently available. Studies that reported numbers of patients who were stone free after primary procedures were included in the stone-free analysis. Studies that reported only the combined number of patients who either were stone free or had "clinically insignificant fragments" were excluded. Many studies did not indicate how or when stone-free status was determined. The stone-free rate was considered at three time points: after the first procedure, after all consecutive procedures using the primary treatment, and after the total treatments. Initially, the Panel divided complications into three broad categories: acute, long-term, and medical; however, after examining the available evidence, the Panel determined that this breakdown was not useful. Several factors caused inaccuracy in the estimates, but did so in opposite directions, thereby reducing the magnitude of inaccuracy. For example, including studies that did not specifically mention that there were no occurrences of a specific complication may have led to overestimates of complication rates when meta-analyzed. By combining similar complications, the Panel also potentially mitigated the overestimate by making it more likely that a complication in the class was reported. The probability that a patient will have a complication may still be overstated slightly because some patients experienced multiple complications. Since the grouping of complications varies by study, the result of the meta-analysis is best interpreted as the mean number of complications that a patient may experience rather than as the probability of having a complication. Moreover, since reporting of complications is not consistent, the estimated rates given here are probably less accurate than the CIs would indicate. There were insufficient data to permit meaningful meta-analyses of patient deaths. Data analyses were conducted for two age groups. One analysis included studies of patients ages 18 or younger (or identified as pediatric patients in the article without specifying age ranges). The adult analysis included all other studies even if children were included. After the evidence was combined and outcome tables were produced, the Panel met to review the results and identify anomalies. From the evidence in the outcome tables and expert opinion, the Panel drafted the treatment guidelines. In this guideline the standard, recommendations, and options given were rated according to the levels of evidence published from the U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research:5 Ia Evidence obtained from meta-analysis of randomized trials Ib Evidence obtained from at least one randomized trial IIa Evidence obtained from at least one well-designed controlled study without randomization IIb Evidence obtained from at least one other type of well-designed quasi-experimental study III Evidence obtained from well-designed nonexperimental studies, such as comparative studies, correlation studies, and case reports IV Evidence obtained from expert committee reports, or opinions, or clinical experience of respected authorities As in the previous AUA guideline, the present statements are graded with respect to the degree of flexibility in application. Although the terminology has changed slightly, from the original AUA reports, the current three levels are essentially the same. A "standard" is the most rigid treatment policy. A "recommendation" has significantly less rigidity, and an "option" has the largest amount of flexibility. These terms are defined as follows: 1 Standard: A guideline statement is a standard if: (1) the health outcomes of the alternative interventions are sufficiently well known to permit meaningful decisions, and (2) there is virtual unanimity about which intervention is preferred. 2 Recommendation: A guideline statement is a recommendation if: (1) the health outcomes of the alternative interventions are sufficiently well known to permit meaningful decisions, and (2) an appreciable, but not unanimous majority agrees on which intervention is preferred. 3 Option: A guideline statement is an option if: (1) the health outcomes of the interventions are not sufficiently well known to permit meaningful decisions, or (2) preferences are unknown or equivocal. The draft was sent to 81 peer reviewers of whom 26 provided comments; the Panel revised the document based on the comments received. The guideline was submitted first for approval to the Practice Guidelines Committee of the AUA and the Guidelines Office of the EAU and then forwarded to the AUA Board of Directors and the EAU Executive Board for final approval. The guideline is posted on the American Urological Association website, www.auanet.org, and on the European Association of Urology website, www.uroweb.org. Chapter 1 will be published in The Journal of Urology and in European Urology. Results of the Outcomes Analysis The results of the analysis described in this chapter provide most of the evidentiary basis for the guideline statements. Further details and tables corresponding to the figures in this section are found in Chapter 3 and the Appendixes. The panel's attempt to differentiate results for pediatric patients from those for adults was not completely successful as most studies included both adults and children. Where possible, the panel performed two analyses, one including all studies regardless of patient age, and a second including only those studies or groups of patients that were comprised entirely of pediatric patients. Observation and Medical Therapies Stone-passage rates Only limited data were found on the topic of spontaneous passage by stone size. For stones ≤5 mm, meta-analysis of five patient groups (224 patients) yielded an estimate that 68% would pass spontaneously (95% CI: 46% to 85%). For stones >5 mm and ≤10 mm, analysis of three groups (104 patients) yielded an estimate that 47% would pass spontaneously (95% CI: 36% to 59%). Details of the meta-analysis are presented in Appendixes 8 and 9. Two medical therapies had sufficient analyzable data: the calcium channel blocker nifedipine and alpha-receptor antagonists. Analyses of stone-passage rates were done in three ways. The first combined all single arms evaluating the therapies. Using this approach, meta-analysis of four studies of nifedipine (160 patients) yielded an estimate of a 75% passage rate (95% CI: 63% to 84%). Six studies examined alpha blockers (280 patients); the meta-analysis yielded a stone-passage rate of 81% (95% CI: 72% to 88%). The second method was a standard Bayesian hierarchical meta-analysis of the available RCTs that compared either nifedipine or alpha blockers to control therapies. The results for nifedipine showed an absolute increase of 9% in stone-passage rates (95% CI: −7% to 25%), which was not statistically significant. Meta-analysis of alpha blockers versus control showed an absolute increase of 29% in the stone-passage rate (95% CI: 20% to 37%), which was statistically significant. The Panel also attempted to determine whether alpha blockers provide superior stone passage when compared to nifedipine. Two randomized controlled trials were identified. When hierarchical meta-analysis was performed on these two studies, tamsulosin provided an absolute increase in stone-passage rate of 14% (95% CI: −4% to 32%) which was not statistically significant. When nonhierarchical methods were used, the stone-passage improvement increased to 16% (95% CI: 7% to 26%) which was statistically significant. Finally, the Panel used the results of the meta-analyses versus controls (second method above) to determine the difference between alpha blockers and calcium channel blockers. This method allows the use of more data but is risky since it depends on the control groups having comparable results. The analysis yielded a 20% improvement in stone-passage rates with alpha blockers, and the 95% CI of 1% to 37% just reached statistical significance. Shock-wave Lithotripsy and Ureteroscopy Stone-free rates were analyzed for a number of variant methods of performing SWL and URS. The Panel attempted to differentiate between bypass, pushback, and in situ SWL as well as differences between lithotripters. Most differences were minimal and did not reach statistical significance. For that reason, the data presented in this Chapter compare the meta-analysis of all forms of SWL to the meta-analysis of all forms of URS. The Panel also attempted to differentiate between flexible and rigid ureteroscopes. Details of the breakdowns by type of SWL and URS are given in Chapter 3. Data were analyzed for both efficacy and complications. Two efficacy outcomes were analyzed: stone-free rate and procedure counts. Complications were grouped into classes. The most important classes are reported herein. The full complication results are in Appendix 10. Analyses were performed for the following patient groups where data were available. 1 Proximal stones ≤10 mm 2 Proximal stones >10 mm 3 Proximal stones regardless of size 4 Mid-ureteral stones ≤10 mm 5 Mid-ureteral stones >10 mm 6 Mid-ureteral stones regardless of size 7 Distal stones ≤10 mm 8 Distal stones >10 mm 9 Distal stones regardless of size Analyses of pediatric groups were attempted for the same nine groups, although data were lacking for many groups. Efficacy Outcomes Stone-free rates The Panel decided to analyze a single stone-free rate. If the study reported the stone-free rate after all primary procedures, that number was used. If not and the study reported the stone-free rate after the first procedure, then that number was used. The intention of the Panel was to provide an estimate of the number of primary procedures and the stone-free rate after those procedures. There is a lack of uniformity in the literature in reporting the time to stone-free status, thereby limiting the ability to comment on the timing of this parameter. The results of the meta-analysis of stone-free data are presented for the overall group in Table 1 and Figure 1. The results are presented as medians of the posterior distribution (best central estimate) with 95% credible intervals (Bayesian confidence intervals). Table 1. Stone-free rates for SWL and URS in the overall population Overall Population AUA/EAU Ureteral Stones Guideline Panel Stone Free Rate—Primary Treatments or First Treatment SWL URS G/P Med/95% CI G/P Med/95% CI Distal Distal ureter mm Distal ureter mm 8 ureter mm 5 5 ureter mm 2 5 Proximal 81% Proximal ureter mm 9 Proximal ureter mm 68% 8 of arms of in those groups 1. Stone-free rates for SWL and URS in the overall This analysis that for stones in the proximal ureter there was no difference in stone-free rates between SWL and URS. for proximal ureteral stones <10 mm SWL had a stone-free rate than and for stones >10 mm URS had superior stone-free This difference because the stone-free rate for proximal ureteral stones with URS did not vary significantly with size, the stone-free rate following SWL with stone size. For all distal URS stone-free rates overall and in both size For all URS but the number of patients may have results from statistical significance. Unfortunately, RCTs comparing these treatments were making an accurate the posterior distributions resulting from the meta-analysis can be yielding a distribution for the difference between the treatments. If the CI of this result not then the results may be considered to be statistically significantly This is but if the patients different treatments are different or if outcome measures are results may be the Panel performed the and found that URS stone-free rates were significantly than SWL rates for distal ureteral stones ≤10 mm and >10 mm and for proximal ureteral stones >10 The stone-free rate for stones was not statistically significantly different between URS and The results with URS using a flexible for proximal ureteral stones than those with a rigid but not at a statistically Stone-free results for pediatric patients are in Table 2 and Figure The very number of patients in most groups, for treatments it that SWL may be more in the pediatric than in the overall in the mid and Table Stone-free rates for SWL and pediatric population Population AUA/EAU Ureteral Stones Guideline Panel Stone Free Rate—Primary Treatments or First Treatment SWL URS G/P Med/95% CI G/P Med/95% CI Distal 8 9 Distal ureter mm 5 2 Distal ureter mm 2 26 6 3 ureter mm 4 ureter mm 1 1 6 5 Proximal 7 81% 5 18 Proximal ureter mm 5 Proximal ureter mm 3 63% of arms of in those groups Stone-free rates for SWL and pediatric were as three 1 Primary number of the procedure was performed. 2 Secondary number of an alternative stone removal was performed. 3 Adjunctive procedures performed at a time other than when the primary or secondary procedures were these could procedures to the procedures such as as well as procedures performed to with most adjunctive procedures in the data presented It is likely that many adjunctive procedures were and the adjunctive procedure may be As in Chapter it was not to a meta-analysis or to for statistically differences between treatments due to the lack of variance data, and only weighted could be The procedure results for the overall population are in Table 3 and Figure 3 results are presented as Table 3. for SWL and URS in the overall population Overall Population SWL URS Primary Secondary Adjunctive Primary Secondary Adjunctive Distal Distal ureter mm Distal ureter mm ureter mm ureter mm Proximal Proximal ureter mm Proximal ureter mm 3. for SWL and URS in the overall results for pediatric patients are in Table 4 and Figure the numbers of patients with available data were and did not meaningful treatments. Table for SWL and URS in the pediatric all Population SWL URS Primary Secondary Adjunctive Primary Secondary Adjunctive Distal Distal ureter mm