2007 Guideline for the Management of Ureteral Calculi

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 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 SWL URS CI 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 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 SWL URS CI 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