American Urological Association - Surgical Management of Stones: AUA/Endourology Society Guideline

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Surgical Management of Stones: AUA/Endourology Society Guideline

Unabridged Version of this Guideline [pdf]

Panel Members

Dean Assimos, MD; Amy Krambeck, MD; Nicole L. Miller, MD; Manoj Monga, MD; M. Hassan Murad, MD, MPH; Caleb P. Nelson, MD, MPH; Kenneth T. Pace, MD; Vernon M. Pais Jr., MD; Margaret S. Pearle, MD, Ph.D; Glenn M. Preminger, MD; Hassan Razvi, MD; Ojas Shah, MD; Brian R. Matlaga, MD, MPH

Executive Summary

Purpose

The purpose of this Guideline is to provide a clinical framework for the surgical management of patients with kidney and/or ureteral stones.

Methodology

A systematic review of the literature using the Medline In-Process & Other Non-Indexed Citations, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus databases (search dates 1/1/1985 to 5/31/15) was conducted to identify peer-reviewed studies relevant to the surgical management of stones. The review yielded an evidence base of 1,911 articles after application of inclusion/exclusion criteria. These publications were used to create the guideline statements. If sufficient evidence existed, then the body of evidence for a particular treatment was assigned a strength rating of A (high quality evidence; high certainty), B (moderate quality evidence; moderate certainty), or C (low quality evidence; low certainty). Evidence-based statements of Strong, Moderate, or Conditional Recommendation, which can be supported by any body of evidence strength, were developed based on benefits and risks/burdens to patients. Additional information is provided as Clinical Principles and Expert Opinions when insufficient evidence existed.

Guideline Statements

Imaging, Pre-operative Testing

1. Clinicians should obtain a non-contrast CT scan on patients prior to performing PCNL. Strong Recommendation; Evidence Level Grade C

2. Clinicians may obtain a non-contrast CT scan to help select the best candidate for SWL versus URS. Conditional Recommendation; Evidence Level Grade C

3. Clinicians may obtain a functional imaging study (DTPA or MAG‐3) if clinically significant loss of renal function in the involved kidney or kidneys is suspected. Conditional Recommendation; Evidence Level Grade C

4. Clinicians are required to obtain a urinalysis prior to intervention. In patients with clinical or laboratory signs of infection, urine culture should be obtained. Strong Recommendation; Evidence Level Grade B

5. Clinicians should obtain a CBC and platelet count on patients undergoing procedures where there is a significant risk of hemorrhage or for patients with symptoms suggesting anemia, thrombocytopenia, or infection; serum electrolytes and creatinine should be obtained if there is suspicion of reduced renal function. Expert Opinion

6. In patients with complex stones or anatomy, clinicians may obtain additional contrast imaging if further definition of the collecting system and the ureteral anatomy is needed. Conditional Recommendation; Evidence Level Grade C

Treatment of Adult Patients with Ureteral Stones

7. Patients with uncomplicated ureteral stones ≤10 mm should be offered observation, and those with distal stones of similar size should be offered MET with α-blockers. (Index Patient 3) Strong Recommendation; Evidence Level Grade B

8. Clinicians should offer reimaging to patients prior to surgery if passage of stones is suspected or if stone movement will change management. Reimaging should focus on the region of interest and limit radiation exposure to uninvolved regions. Clinical Principle

9. In most patients, if observation with or without MET is not successful after four to six weeks and/or the patient/clinician decide to intervene sooner based on a shared decision making approach, clinicians should offer definitive stone treatment. (Index Patients 1-3) Moderate Recommendation; Evidence Level Grade C

10. Clinicians should inform patients that SWL is the procedure with the least morbidity and lowest complication rate, but URS has a greater stone-free rate in a single procedure. (Index Patients 1-6) Strong Recommendation; Evidence Level Grade B

11. In patients with mid or distal ureteral stones who require intervention (who were not candidates for or who failed MET), clinicians should recommend URS as first-line therapy. For patients who decline URS, clinicians should offer SWL. (Index Patients 2,3,5,6) Strong Recommendation; Evidence Level Grade B

12. URS is recommended for patients with suspected cystine or uric acid ureteral stones who fail MET or desire intervention. Expert Opinion

13. Routine stenting should not be performed in patients undergoing SWL. (Index Patients 1-6) Strong Recommendation; Evidence Level Grade B

14. Following URS, clinicians may omit ureteral stenting in patients meeting all of the following criteria: those without suspected ureteric injury during URS, those without evidence of ureteral stricture or other anatomical impediments to stone fragment clearance, those with a normal contralateral kidney, those without renal functional impairment, and those in whom a secondary URS procedure is not planned. (Index Patients 1-6) Strong Recommendation; Evidence Level Grade A

15. Placement of a ureteral stent prior to URS should not be performed routinely. (Index Patient 1-6) Strong Recommendation; Evidence Level Grade B

16. Clinicians may offer α-blockers and antimuscarinic therapy to reduce stent discomfort. (Index patients 1-6) Moderate Recommendation; Evidence Level Grade B

17. In patients who fail or are unlikely to have successful results with SWL and/or URS, clinicians may offer PCNL, laparoscopic, open, or robotic assisted stone removal. (Index patient 1-6) Moderate Recommendation; Evidence Level Grade C

19. Clinicians should not utilize EHL as the first-line modality for intra-ureteral lithotripsy. (Index patients 1-6,13,15) Expert Opinion

20. In patients with obstructing stones and suspected infection, clinicians must urgently drain the collecting system with a stent or nephrostomy tube and delay stone treatment. Strong Recommendation; Evidence Level Grade C

Treatment of Adult Patients with Renal Stones

21. In symptomatic patients with a total non-lower pole renal stone burden ≤ 20 mm, clinicians may offer SWL or URS. (Index Patient 7) Strong Recommendation; Evidence Level Grade B

22. In symptomatic patients with a total renal stone burden >20 mm, clinicians should offer PCNL as first-line therapy. (Index Patient 8) Strong Recommendation; Evidence Level Grade C

25. In patients with total renal stone burden >20 mm, clinicians should not offer SWL as first-line therapy. (Index Patient 8) Moderate Recommendation; Evidence Level Grade C

27. Clinicians may perform nephrectomy when the involved kidney has negligible function in patients requiring treatment. (Index Patients 1-14) Conditional Recommendation; Evidence Level Grade C

28. For patients with symptomatic (flank pain), non-obstructing, caliceal stones without another obvious etiology for pain, clinicians may offer stone treatment. (Index Patient 12) Moderate Recommendation; Evidence Level Grade C

29. For patients with asymptomatic, non-obstructing caliceal stones, clinicians may offer active surveillance. Conditional Recommendation; Evidence Level Grade C

30. Clinicians should offer SWL or URS to patients with symptomatic ≤ 10 mm lower pole renal stones. (Index Patient 9) Strong Recommendation; Evidence Level Grade B

31. Clinicians should not offer SWL as first-line therapy to patients with >10mm lower pole stones. (Index Patient 10) Strong Recommendation; Evidence Level Grade B

32. Clinicians should inform patients with lower pole stones >10 mm in size that PCNL has a higher stone-free rate but greater morbidity. (Index patient 10). Strong Recommendation; Evidence Level Grade B

33. In patients undergoing uncomplicated PCNL who are presumed stone-free, placement of a nephrostomy tube is optional. Conditional Recommendation; Evidence Level Grade C

34. Flexible nephroscopy should be a routine part of standard PCNL. Strong Recommendation; Evidence Level Grade B

35. Clinicians must use normal saline irrigation for PCNL and URS. Strong Recommendation; Evidence Level Grade B

39. In patients not considered candidates for PCNL, clinicians may offer staged URS. Moderate Recommendation; Evidence Level Grade C

40. Clinicians may prescribe α-blockers to facilitate passage of stone fragments following SWL. Moderate Recommendation; Evidence Level Grade B

43. SWL should not be used in the patient with anatomic or functional obstruction of the collecting system or ureter distal to the stone. Strong Recommendation; Evidence Level Grade C

44. In patients with symptomatic caliceal diverticular stones, endoscopic therapy (URS, PCNL, laparoscopic, robotic) should be preferentially utilized. Strong Recommendation; Evidence Level Grade C

45. Staghorn stones should be removed if attendant comorbidities do not preclude treatment. Clinical Principle

Treatment for Pediatric Patients with Ureteral or Renal Stones

46. In pediatric patients with uncomplicated ureteral stones ≤10 mm, clinicians should offer observation with or without MET using α-blockers. (Index Patient 13) Moderate Recommendation; Evidence Level Grade B

47. Clinicians should offer URS or SWL for pediatric patients with ureteral stones who are unlikely to pass the stones or who failed observation and/or MET, based on patient-specific anatomy and body habitus. (Index Patient 13) Strong Recommendation; Evidence Level Grade B

48. Clinicians should obtain a low-dose CT scan on pediatric patients prior to performing PCNL. (Index Patient 13) Strong Recommendation; Evidence Level Grade C

49. In pediatric patients with ureteral stones, clinicians should not routinely place a stent prior to URS. (Index Patient 13) Expert Opinion

50. In pediatric patients with a total renal stone burden ≤20mm, clinicians may offer SWL or URS as first-line therapy. (Index Patient 14) Moderate Recommendation; Evidence Level Grade C

51. In pediatric patients with a total renal stone burden >20mm, both PCNL and SWL are acceptable treatment options. If SWL is utilized, clinicians should place an internalized ureteral stent or nephrostomy tube. (Index Patient 14) Expert Opinion

52. In pediatric patients, except in cases of coexisting anatomic abnormalities, clinicians should not routinely perform open/laparoscopic/robotic surgery for upper tract stones. (Index Patients 13, 14) Expert Opinion

53. In pediatric patients with asymptomatic and non-obstructing renal stones, clinicians may utilize active surveillance with periodic ultrasonography. (Index Patient 14) Expert Opinion

Treatment for Pregnant Patients with Ureteral or Renal Stones

54. In pregnant patients, clinicians should coordinate pharmacological and surgical intervention with the obstetrician. (Index Patient 15) Clinical Principal

55. In pregnant patients with ureteral stones and well controlled symptoms, clinicians should offer observation as first-line therapy. (Index Patient 15) Strong recommendation; Evidence Level Grade B

56. In pregnant patients with ureteral stones, clinicians may offer URS to patients who fail observation. Ureteral stent and nephrostomy tube are alternative options with frequent stent or tube changes usually being necessary. (Index Patient 15) Strong Recommendation; Evidence Level Grade C

Treatment for all Patients with Ureteral or Renal Stones

23. When residual fragments are present, clinicians should offer patients endoscopic procedures to render the patients stone free, especially if infection stones are suspected. (Index Patient 11) Moderate Recommendation; Evidence Level Grade C

24. Stone material should be sent for analysis. Clinical Principle

26. Open/ laparoscopic /robotic surgery should not be offered as first-line therapy to most patients with stones. Exceptions include rare cases of anatomic abnormalities, with large or complex stones, or those requiring concomitant reconstruction. (Index Patients 1-15) Strong Recommendation; Evidence Level Grade C

36. A safety guide wire should be used for most endoscopic procedures. (Index Patients 1-15) Expert Opinion

37. Antimicrobial prophylaxis should be administered prior to stone intervention and is based primarily on prior urine culture results, the local antibiogram, and in consultation with the current Best Practice Policy Statement on Urologic Surgery Antibiotic Prophylaxis. Clinical Principle

38. Clinicians should abort stone removal procedures, establish appropriate drainage, continue antibiotic therapy, and obtain a urine culture if purulent urine is encountered during endoscopic intervention. (Index Patients1-15) Strong Recommendation; Evidence Level Grade C

41. If initial SWL fails, clinicians should offer endoscopic therapy as the next treatment option. (Index Patient 1-14) Moderate Recommendation; Evidence Level Grade C

42. Clinicians should use URS as first-line therapy in most patients who require stone intervention in the setting of uncorrected bleeding diatheses or who require continuous anticoagulation/antiplatelet therapy. (Index Patients1-15) Strong Recommendation; Evidence Level Grade C

Background

Kidney stones are a common and costly disease; it has been reported that over 8.8% of the United States population will be affected by this malady, and direct and indirect treatment costs are estimated to be several billion dollars per year in this country.1-3 The surgical treatment of kidney stones is complex, as there are multiple competitive treatment modalities, and in certain cases more than one modality may be appropriate. Proper treatment selection, which is directed by patient- and stone-specific factors, remains the greatest predictor of successful treatment outcomes. The Panel used information from the literature to formulate actionable guideline statements to assist clinicians in providing the best care for their patients requiring stone elimination. 

This Guideline includes revisions of the previously published AUA Guidelines titled 'Staghorn Calculi (2005)'4 and 'Ureteral Calculi (2007)'5 and is expanded to incorporate the management of patients with non-staghorn renal stones. The Update Literature Review (ULR) process for AUA Guidelines was used to determine that updates were warranted for both the Staghorn Calculi and Ureteral Calculi Guidelines. A guideline for the management of non-staghorn renal stones had previously not been generated by the AUA. The AUA and the Endourological Society felt that a single, all-encompassing guideline document would provide the greatest value to the clinician for patient management. This Guideline also compliments the AUA Guideline on 'Medical Management of Kidney Stones' published in 2014.6

The surgical management of patients with various stones is described below and divided into 13 respective patient profiles. Index Patients 1-10 are non-morbidly obese; non-pregnant adults (≥ 18 years of age) with stones not thought to be composed of uric acid or cystine; normal renal, coagulation and platelet function; normally positioned kidneys; intact lower urinary tracts without ectopic ureters; no evidence of sepsis; and no anatomic or functional obstruction distal to the stone(s). Index Patients 13 and 14 are children (<18 years if age) with similar characteristics to Index Patients 1-10. Index Patient 15 is a pregnant female with symptomatic renal or ureteral stone(s) with normal renal function without urinary tract infection (UTI). The proximal ureter is defined as the segment distal to the ureteropelvic junction (UPJ) and above the upper border of the sacroiliac joint. The middle ureter is that which overlies the sacroiliac joint and the distal ureter that lies below it.

Index Patients

Index Patient 1: Adult, <10mm proximal ureteral stone

Index Patient 2: Adult, <10mm mid ureteral stone

Index Patient 3: Adult, <10mm distal ureteral stone

Index Patient 4: Adult, >10mm proximal ureteral stone

Index Patient 5: Adult, >10mm mid ureteral stone

Index Patient 6: Adult, > 10 mm distal ureteral stone

Index Patient 7: Adult, ≤20mm total non-lower pole renal stone burden

Index Patient 8: Adult, >20mm total renal stone burden

Index Patient 9: Adult, ≤10mm lower pole renal stone(s)

Index Patient 10: Adult, >10mm lower pole renal stone(s)

Index Patient 11: Adult, with residual stone(s)

Index Patient 12: Adult, renal stone(s) with pain and no obstruction

Index Patient 13: Child, not known to have cystine or uric acid ureteral stone(s)

Index Patient 14: Child, not known to have cystine or uric acid renal stone(s)

Index Patient 15: Pregnant female, renal or ureteral stone(s)

Methodology

Process for Initial Literature Selection
Consistent with the published AUA Guideline methodology framework,7 the process started by conducting a comprehensive systematic review. The AUA commissioned an independent group to conduct a systematic review and meta-analysis of the published literature on various options for the surgical management of stones.8 The protocol of the systematic review was developed a priori by the methodology team in conjunction with the expert panel. A systematic review was conducted to identify published articles relevant to the surgical management of renal or ureteral stones. Literature searches were performed on English-language publications using the Medline In-Process & Other Non-Indexed Citations, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus from 1/1/1985 to 5/31/2015. Preclinical studies (e.g., animal models), commentary, and editorials were excluded. Studies on patients with lower tract stones were excluded (including bladder stones and diversions). Bibliographies of review articles were checked to ensure inclusion of all possibly relevant studies. Multiple reports on the same patient group were carefully examined to ensure inclusion of only non-redundant information. The systematic review yielded a total of 1,911 studies. The Panel and methodology group continued to monitor the literature for relevant randomized trials thereafter and added several newer trials published through 2015.

The Panel judged that there was a sufficient evidence base from which to construct the Guideline. Data on study type (e.g., randomized controlled trial [RCT], controlled clinical trial [CCT], observational study), perioperative testing, treatment parameters (e.g., type of treatment), patient characteristics (e.g., age, stone size and location), outcomes (e.g., stone-free rate, residual fragments, quality of life [QoL]) and complications were extracted.

Almost all the studies that reported on preoperative testing (99 computed tomography [CT] scan, 10 renal scan, 128 renal ultrasound [US], 188 KUB, 156 intravenous pyelogram [IVP], 68 complete blood count [CBC], 29 stone analysis and 112 urine culture) did not report the purpose of performing these tests. There were no reliable data on the utility or incremental value of testing. The procedures of interest were percutaneous nephrolithotomy (PCNL), ureteroscopy (URS), laparoscopy, shock-wave lithotripsy (SWL), open surgery, robotic surgery, ureteral stent, or nephrostomy. Comparison of any of these active treatments against each other or against medical management was done when possible. Medical expulsive therapy (MET) was evaluated in terms of efficacy against placebo. Outcomes included stone-free rate (as determined by KUB, US, IVP, nephrotomogram, CT, endoscopy); residual fragments (by size); secondary procedures needed (stone-removing versus ancillary); QoL; pain; analgesic requirements; length of hospitalization; comparative recurrence rates; renal function; and procedure complications (e.g., death, sepsis/sirs, transfusion, loss of kidney, readmission rates, overall rates). When multiple studies evaluated the same outcome and had similar population, intervention, and comparison, meta-analysis was conducted using the random effects model, when appropriate.8 Stone-free rate was stratified based on stone size and location.

The methodology team independently rated the methodological quality of the studies and provided an overall judgment of the whole body of evidence based on confidence in the available estimates of effect.

The methodology team summarized the data with explicit description of study characteristics, methodological quality, main findings, and quality of the evidence (confidence in the estimates). The methodology team attended panel meetings and facilitated incorporation of the evidence into the Guideline.

Quality of Individual Studies and Determination of Evidence Strength

The quality of individual studies that were either RCTs or CCTs was assessed using the Cochrane Risk of Bias tool.9 The quality of CCTs and comparative observational studies was rated using the Newcastle-Ottawa Quality (NOQ) Assessment Scale.10 Because there is no widely-agreed upon quality assessment tool for single cohort observational studies, the quality of these studies was not assessed.

The categorization of evidence strength is conceptually distinct from the quality of individual studies (the latter is also called the risk of bias). Evidence strength refers to the body of evidence available for a particular question and includes not only individual study quality but consideration of study design; consistency of findings across studies; adequacy of sample sizes; and generalizability of samples, settings, and treatments for the purposes of the Guideline. The AUA categorizes body of evidence strength as Grade A (well-conducted and highly-generalizable RCTs or exceptionally strong observational studies with consistent findings), Grade B (RCTs with some weaknesses of procedure or generalizability or moderately strong observational studies with consistent findings), or Grade C (RCTs with serious deficiencies of procedure or generalizability or extremely small sample sizes or observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data). By definition, Grade A evidence is evidence about which the Panel has a high level of certainty, Grade B evidence is evidence about which the Panel has a moderate level of certainty, and Grade C evidence is evidence about which the Panel has a low level of certainty.7

AUA Nomenclature: Linking Statement Type to Evidence Strength

The AUA nomenclature system links statement type to body of evidence strength, level of certainty, magnitude of benefit or risk/burdens, and the Panel's judgment regarding the balance between benefits and risks/burdens (see Table 1). Strong Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is substantial. Moderate Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is moderate. Conditional Recommendations are non-directive statements used when the evidence indicates that there is no apparent net benefit or harm or when the balance between benefits and risks/burden is unclear. All three statement types may be supported by any body of evidence strength grade. Body of evidence strength Grade A in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances and that future research is unlikely to change confidence. Body of evidence strength Grade B in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence could change confidence. Body of evidence strength Grade C in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence is likely to change confidence. Body of evidence strength Grade C is rarely used in support of a Strong Recommendation. Conditional Recommendations also can be supported by any body of evidence strength. When body of evidence strength is Grade A, the statement indicates that benefits and risks/burdens appear balanced, the best action depends on patient circumstances, and future research is unlikely to change confidence. When body of evidence strength Grade B is used, benefits and risks/burdens appear balanced, the best action also depends on individual patient circumstances and better evidence could change confidence. When body of evidence strength Grade C is used, there is uncertainty regarding the balance between benefits and risks/burdens, alternative strategies may be equally reasonable, and better evidence is likely to change confidence.

For some clinical issues, particularly diagnosis, there was little or no evidence from which to construct evidence-based statements. Where gaps in the evidence existed, the Panel provides guidance in the form of Clinical Principles or Expert Opinions with consensus achieved using a modified Delphi technique if differences of opinion emerged.11 A Clinical Principle is a statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature. Expert Opinion refers to a statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there is no evidence.

Panel Selection and Peer Review Process

The Surgical Management of Stones Panel was created in 2013 by the American Urological Association Education and Research, Inc. (AUA). The Practice Guidelines Committee (PGC) of the AUA selected the Panel Chair who in turn appointed the additional panel members with specific expertise in this area. The Endourological Society also nominated two representatives to serve on the panel. Once nominated, all panel members were asked to record their conflict of interest (COI) statements, providing specific details on the AUA interactive web site. These details are first reviewed by the Guidelines Oversight Committee (GOC), a member sub-committee from the PGC consisting of the Vice Chair of the PGC and two other members. The GOC determines whether the individual has potential conflicts related to the guideline. If there are conflicts, then the nominee's COI is reviewed and approved by the AUA Judicial and Ethics (J&E) committee. A majority of panel members may not have relationships relevant to the Guideline topic.

The AUA conducted a thorough peer review process. The draft guidelines document was distributed to 109 peer reviewers, 54 of whom provided comments. The Panel reviewed and discussed all submitted comments and revised the draft as needed. Once finalized, the Guideline was submitted for approval to the PGC and Science and Quality Council (S&Q). Then it was submitted to the AUA Board of Directors and the Endourological Society Board of Directors for final approval. Funding of the panel was provided by the AUA, with support from The Endourological Society; panel members received no remuneration for their work.

Limitations of the Literature

Evidence to guide perioperative diagnostic evaluation was sparse and of low quality, affecting recommendations on laboratory testing and imaging. Data on stone-free rate (lithotripsy, URS and PCNL) when stratified by location and stone size were also limited in clinical trials; therefore, rates were also derived from large registries that provided precise, although likely biased, estimates. Comparative effectiveness of MET was derived from a large number of trials that overall has a moderate risk of bias. Only a very small number of studies were available to provide comparative effectiveness inferences in children.

Imaging, Pre-operative Testing

Guideline Statement 1

Clinicians should obtain a non-contrast CT scan on patients prior to performing PCNL. Strong Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 2

Clinicians may obtain a non-contrast CT scan to help select the best candidate for SWL versus URS. Conditional Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 3

Clinicians may obtain a functional imaging study (DTPA or MAG‐3) if clinically significant loss of renal function in the involved kidney or kidneys is suspected. Conditional Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 4

Clinicians are required to obtain a urinalysis prior to intervention. In patients with clinical or laboratory signs of infection, urine culture should be obtained. Strong recommendation; Evidence Level Grade B

Discussion


Guideline Statement 5

Clinicians should obtain a CBC and platelet count on patients undergoing procedures where there is a significant risk of hemorrhage or for patients with symptoms suggesting anemia, thrombocytopenia, or infection; serum electrolytes and creatinine should be obtained if there is suspicion of reduced renal function. Expert Opinion

Discussion


Guideline Statement 6

In patients with complex stones or anatomy, clinicians may obtain additional contrast imaging if further definition of the collecting system and the ureteral anatomy is needed. Conditional recommendation; Evidence Level Grade C

Discussion


Treatment of Adult Patients with Ureteral Stones

Guideline Statement 7

Patients with uncomplicated ureteral stones ≤10 mm should be offered observation, and those with distal stones of similar size should be offered MET with α-blockers. (Index Patient 3) Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 8

Clinicians should offer reimaging to patients prior to surgery if passage of stones is suspected or if stone movement will change management. Reimaging should focus on the region of interest and limit radiation exposure to uninvolved regions. Clinical Principle

Discussion


In most patients, if observation with or without MET is not successful after four to six weeks and/or the patient/clinician decide to intervene sooner based on a shared decision making approach, the clinicians should offer definitive stone treatment. (Index Patients 1-3) Moderate Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 10

Clinicians should inform patients that SWL is the procedure with the least morbidity and lowest complication rate, but URS has a greater stone-free rate in a single procedure. (Index Patients 1-6) Strong Recommendation, Evidence Level Grade B

Discussion


Guideline Statement 11

In patients with mid or distal ureteral stones who require intervention (who were not candidates for or who failed MET), clinicians should recommend URS as first-line therapy. For patients who decline URS, clinicians should offer SWL. (Index Patients 2,3,5,6) Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 12

URS is recommended for patients with suspected cystine or uric acid ureteral stones who fail MET or desire intervention. Expert Opinion

Discussion


Guideline Statement 13

Routine stenting should not be performed in patients undergoing SWL. (Index Patients 1-6) Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 14

Following URS, clinicians may omit ureteral stenting in patients meeting all of the following criteria

those without suspected ureteric injury during URS, those without evidence of ureteral stricture or other anatomical impediments to stone fragment clearance, those with a normal contralateral kidney, those without renal functional impairment, and those in whom a secondary URS procedure is not planned. (Index Patients 1-6) Strong Recommendation; Evidence Level Grade A

Discussion


Guideline Statement 15

Placement of a ureteral stent prior to URS should not be performed routinely. (Index Patient 1-6) Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 16

Clinicians may offer α-blockers and antimuscarinic therapy to reduce stent discomfort. (Index patients 1-6) Moderate Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 17

In patients who fail or are unlikely to have successful results with SWL and/or URS, clinicians may offer PCNL, laparoscopic, open, or robotic assisted stone removal. (Index patient 1-6) Moderate Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 18

Clinicians performing URS for proximal ureteral stones should have a flexible ureteroscope available. (Index Patients 1, 4) Clinical Principle

Discussion


Guideline Statement 19

Clinicians should not utilize EHL as the first-line modality for intra-ureteral lithotripsy. (Index patients 1-6,13,15) Expert Opinion

Discussion


Guideline Statement 20

In patients with obstructing stones and suspected infection, clinicians must urgently drain the collecting system with a stent or nephrostomy tube and delay stone treatment. Strong Recommendation; Evidence Level Grade C

Discussion


Treatment of Adult Patients with Renal Stones

Guideline Statement 21

In symptomatic patients with a total non-lower pole renal stone burden < 20 mm, clinicians may offer SWL or URS. (Index Patient 7) Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 22

In symptomatic patients with a total renal stone burden >20 mm, clinicians should offer PCNL as first-line therapy. (Index Patient 8) Strong Recommendation; Evidence Level Grade C

Discussion


In patients with total renal stone burden >20 mm, clinicians should not offer SWL as first-line therapy. (Index Patient 8) Moderate Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 27

Clinicians may perform nephrectomy when the involved kidney has negligible function in patients requiring treatment. (Index Patients 1-14) Conditional Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 28

For patients with symptomatic (flank pain), non-obstructing, caliceal stones without another obvious etiology for pain, clinicians may offer stone treatment. (Index Patient 12) Moderate Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 29

For patients with asymptomatic, non-obstructing caliceal stones, clinicians may offer active surveillance. Conditional Recommendation; Evidence Level grade C

Discussion


Guideline Statement 30

Clinicians should offer SWL or URS to patients with symptomatic ≤ 10 mm lower pole renal stones. (Index Patient 9) Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 31

Clinicians should not offer SWL as first-line therapy to patients with >10mm lower pole stones. (Index Patient 10) Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 32

Clinicians should inform patients with lower pole stones >10 mm in size that PCNL has a higher stone-free rate but greater morbidity. (Index patient 10). Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 33

In patients undergoing uncomplicated PCNL who are presumed stone-free, placement of a nephrostomy tube is optional. Conditional Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 34

Flexible nephroscopy should be a routine part of standard PCNL. Strong recommendation; Evidence Level Grade B

Discussion


Guideline Statement 35

Clinicians must use normal saline irrigation for PCNL and URS. Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 39

In patients not considered candidates for PCNL, clinicians may offer staged URS. Moderate Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 40

Clinicians may prescribe α-blockers to facilitate passage of stone fragments following SWL. Moderate Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 43

SWL should not be used in the patient with anatomic or functional obstruction of the collecting system or ureter distal to the stone. Strong Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 44

In patients with symptomatic caliceal diverticular stones, endoscopic therapy (URS, PCNL, laparoscopic, robotic) should be preferentially utilized. Strong Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 45

Staghorn stones should be removed if attendant comorbidities do not preclude treatment. Clinical Principle

Discussion


Treatment for Pediatric Patients with Ureteral or Renal Stones

Guideline Statement 46

In pediatric patients with uncomplicated ureteral stones ≤10 mm, clinicians should offer observation with or without MET using α-blockers. (Index Patient 13) Moderate Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 47

Clinicians should offer URS or SWL for pediatric patients with ureteral stones who are unlikely to pass the stones or who failed observation and/or MET, based on patient-specific anatomy and body habitus. (Index Patient 13) Strong Recommendation; Evidence Level Grade B

Discussion


Guideline Statement 48

Clinicians should obtain a non-contrast, low-dose CT scan on pediatric patients prior to performing PCNL. (Index Patient 13) Strong Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 49

Discussion


Guideline Statement 50

In pediatric patients with a total renal stone burden ≤20mm, clinicians may offer SWL or URS as first-line therapy. (Index Patient 14) Moderate Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 51

In pediatric patients with a total renal stone burden >20mm, both PCNL and SWL are acceptable treatment options. (Index Patient 14) Moderate Recommendation; Evidence Level Grade C

Guideline Statement 52

In pediatric patients, except in cases of coexisting anatomic abnormalities, clinicians should not routinely perform open/laparoscopic/robotic surgery for upper tract stones. (Index Patients 13, 14) Expert Opinion

Discussion


Guideline Statement 53

In pediatric patients with asymptomatic and non-obstructing renal stones, clinicians may utilize active surveillance with periodic ultrasonography. (Index Patient 14) Expert Opinion

Discussion


Treatment for Pregnant Patients with Ureteral or Renal Stones

Guideline Statement 54

In pregnant patients, clinicians should coordinate pharmacological and surgical intervention with the obstetrician. (Index Patient 15) Clinical Principal

Discussion


Guideline Statement 55

In pregnant patients with ureteral stone(s) and well controlled symptoms, clinicians should offer observation as first-line therapy. (Index Patient 15) Strong recommendation; Evidence Level Grade B

Discussion


Guideline Statement 56

In pregnant patients with ureteral stones, clinicians may offer URS to patients who fail observation. Ureteral stent and nephrostomy tube are alternative options with frequent stent or tube changes usually being necessary. (Index Patient 15) Strong Recommendation; Evidence Level Grade C

Discussion


Treatment for all Patients with Ureteral or Renal Stones

Guideline Statement 23

When residual fragments are present, clinicians should offer patients endoscopic procedures to render the patients stone-free, especially if infection stones are suspected. (Index Patient 11) Moderate Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 24

Stone material should be sent for analysis. Clinical Principle

Discussion


Guideline Statement 26

Open/laparoscopic/robotic surgery should not be offered as first-line therapy to most patients with stones. Exceptions include rare cases of anatomic abnormalities, with large or complex stones, or those requiring concomitant reconstruction. (Index Patients 1-15) Strong Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 36

A safety guide wire should be used for most endoscopic procedures. (Index Patients 1-15) Expert Opinion

Discussion


Guideline Statement 37

Antimicrobial prophylaxis should be administered prior to stone intervention and is based primarily on prior urine culture results, the local antibiogram, and in consultation with the current Best Practice Policy Statements on Antibiotic Prophylaxis. Clinical Principle

Discussion


Guideline Statement 38

Clinicians should abort stone removal procedures, establish appropriate drainage, continue antibiotic therapy, and obtain a urine culture if purulent urine is encountered during endoscopic intervention. (Index Patients1-15) Strong Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 41

If initial SWL fails, clinicians should offer endoscopic therapy as the next treatment option. (Index Patient 1-14) Moderate Recommendation; Evidence Level Grade C

Discussion


Guideline Statement 42

Clinicians should use URS as first-line therapy in most patients who require stone intervention in the setting of uncorrected bleeding diatheses or who require continuous anticoagulation/antiplatelet therapy. (Index Patients1-15) Strong Recommendation; Evidence Level Grade C

Discussion


Future Directions

It is unfortunate that the surgical treatment of kidney stones, a disease with such a great prevalence, has not been studied with greater rigor in previous years. One of the most disappointing aspects of the systematic review performed herein is the small number of high quality research studies identified. There is an extreme paucity of high quality RCTs comparing competitive surgical interventions for stone disease. However, this is not surprising, given that other urologic fields are also underpopulated with such studies.

Going forward, it will be beneficial to standardize the reporting of stone treatment studies. At present, there is great heterogeneity in the definitions of such important metrics as stone size, stone location, stone-free status, complications and economic outcomes. This terminology should be standardized as this will allow more reliable comparisons among studies, and make systematic reviews and meta-analyses more powerful.

Clinicians' ability to utilize imaging studies to predict treatment outcomes for differing stone interventions is limited at present. As a result, we cannot completely counsel patients on their likely course following a stone removal intervention. This is particularly true for SWL, where our pre-treatment understanding of stone fragility is lacking. It would be most welcome for the clinician to be better able to predict treatment outcomes from presently available imaging modalities. Furthermore, efforts should also be focused on identifying and advancing the utility of imaging modalities that do not rely on ionizing radiation such as MRI and ultrasonography.

Many patients with a symptomatic ureteral stone will pass their stones spontaneously. From a patient-centered standpoint, time course to passage, as well as maneuvers to increase the probability of spontaneous passage are exceedingly important. Clinicians' ability to counsel patients on how long it will take for a stone to pass is limited due in great part to a lack of research focused on answering this question. With regards to augmenting stone passage utilizing pharmacotherapy, our understanding is unclear as the literature is conflicted. Future studies better defining the ability of MET to promote stone passage will be important to improving the patient experience. In addition, the development of agents with better efficacy and tolerability to facilitate stone passage is warranted.

The mechanical action of stone fragmentation and removal is the primary driver of intra-operative time allocation during a stone removal procedure. For URS and PCNL, the technologies accomplish the same end, but via different mechanisms. For patients undergoing URS, in particular flexible URS, the Holmium laser is currently the lithotrite of choice. In some cases the laser may be used to fragment the stone into small pieces that can be individually retrieved; in other cases the laser may be used to fragment the stone into fine powder, which will spontaneously drain from the kidney. At present, it is not known which of these approaches yields superior outcomes, but such information would be immediately useful to the practicing urologist.

There is also a need to improve the devices that are used in the stone fragmentation and evacuation process during endoscopic surgery. With respect to URS, there is a need for mechanical devices that more efficiently and safely fragment and evacuate stone material; at present, this process is cumbersome and potentially dangerous as ureteral injury may occur during stone extraction. With respect to PCNL, advances in stone removal technology will enable a more rapid and efficient evacuation of larger burdens of stone.

Ureteral stent placement is commonly performed following stone interventions. In some cases, stent placement may not be necessary, such as in the case of an uncomplicated ureteroscopic procedure. However, in many of those cases, stents are still placed. It is well recognized that ureteral stents are the source of significant morbidity. Future efforts should be devoted to better identifying which patients may safely avoid stent placement. In addition, advances in stent technology, with a particular focus on identifying the nature and source of stent morbidity, as well as design advances to minimize these bothersome symptoms will also improve surgical care.

Stone disease in the pediatric population has been reported to be increasing. At present, our understanding of stone management among children is somewhat rudimentary, as the published literature is sparse. Future efforts to better define the effects of surgical stone treatment in this population will also be important.

Figures and Tables

Figure 1. Forest plot: Odds ratio of stone-free rate for distal ureteral stones <10 mm in patients receiving any α-Blocker vs. Control

Figure 1. Forest plot: Odds ratio of stone-free rate for distal ureteral stones <10 mm in patients receiving any α-Blocker vs. Control

Figure 2. Forest plot: Odds ratio of stone-free rate for distal ureteral stones in patients receiving Tamsulosin 0.4 mg vs. Control

Figure 2. Forest plot: Odds ratio of stone-free rate for distal ureteral stones in patients receiving Tamsulosin 0.4 mg vs. Control

Figure 3. Forest plot: Odds ratio of stone-free rate for distal ureteral stones < 10 mm in patients receiving Nifedipine vs. Control

Figure 3. Forest plot: Odds ratio of stone-free rate for distal ureteral stones < 10 mm in patients receiving Nifedipine vs. Control

Figure 4. Forest plot: Odds ratio of stone-free rate for proximal ureteral stones in patients receiving any α-Blocker vs. Control

Figure 4. Forest plot: Odds ratio of stone-free rate for proximal ureteral stones in patients receiving any α-Blocker vs. Control

Figure 5. Forest plot: Odds ratio of stone-free rate for middle ureteral stones in patients receiving any α-Blocker vs. Control

Figure 5. Forest plot: Odds ratio of stone-free rate for middle ureteral stones in patients receiving any α-Blocker vs. Control

Figure 6. Stone-free rate in adults, SWL vs. URS

Figure 6. Stone-free rate in adults, SWL vs. URS

Table 1. AUA Nomenclature Linking Statement Type to Level of Certainty,
Magnitude of Benefit or Risk/Burden, and Body of Evidence Strength
 Evidence Strength A
(High Certainty)
Evidence Strength B
(Moderate Certainty)
Evidence Strength C
(Low Certainty)

Strong
Recommendation


(Net benefit or harm substantial)

Benefits > Risks/Burdens (or vice versa)


Net benefit (or net harm) is substantial


Applies to most patients in most circumstances and future research is unlikely to change confidence

Benefits > Risks/Burdens (or vice versa)


Net benefit (or net harm) is substantial


Applies to most patients in most circumstances but better evidence could change confidence

Benefits > Risks/Burdens (or vice versa)


Net benefit (or net harm) appears substantial


Applies to most patients in most circumstances but better evidence is likely to change confidence (rarely used to support a Strong Recommendation)

Moderate Recommendation


(Net benefit or harm moderate)

Benefits > Risks/Burdens (or vice versa)


Net benefit (or net harm) is moderate


Applies to most patients in most circumstances and future research is unlikely to change confidence

Benefits > Risks/Burdens (or vice versa)


Net benefit (or net harm) is moderate


Applies to most patients in most circumstances but better evidence could change confidence

Benefits > Risks/Burdens (or vice versa)


Net benefit (or net harm) appears moderate


Applies to most patients in most circumstances but better evidence is likely to change confidence

Conditional Recommendation


(No apparent net benefit or harm)

Benefits = Risks/Burdens


Best action depends on individual patient circumstances


Future research unlikely to change confidence

Benefits = Risks/Burdens


Best action appears to depend on individual patient circumstances


Better evidence could change confidence

Balance between Benefits & Risks/Burdens unclear


Alternative strategies may be equally reasonable


Better evidence likely to change confidence

Clinical Principle

A statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature

Expert Opinion

A statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there is no evidence

Table 2. Stone-free Rates for SWL and URS
in the Overall Population After all Sessions Performed
Distal UreterOverall Size < 10 mm Size > 10 mm
SWL
 G/PMedianCI (95%)G/PMedianCI (95%)G/PMedianCI (95%)
All forms81/1657374.65%(74-75)%29/1142073.96%(73-75)%22/378571.47%(70-73)%
Bypass---------
In situ7/82676.3%(73-79)%16/25986.5%(82-90)%11/99473.84%(71-77)%
Pushback---------
Other8/48671%(57-82)%3/3590%(75-98)%1/184%(15-100)%
URS
All forms119/1593893.58%(93-94)%19/400894.21%(93-95)%14/170592.26%(91-93)%
Flexible4/15996.8%(92-99)%------
Mixed flexible9/43193%(89-96)%1/3897%(88-100)%1/1079%(50-96)%
Rigid63/425489.9%(89-90)%13/18190.6%(85-94)%8/53394.7%(92-96)%
Semi-rigid30/516997.25%(97-98)%3/23198.70%(96-100)%3/13295.4%(90-98)%

Total UreterOverallSize < 10 mmSize > 10 mm
SWL
 G/PMedianCI (95%)G/PMedianCI (95%)G/PMedianCI (95%)
All forms36/3621568.95%(68-69)%50/1887963.96%(63-65)%38/743361.62%(61-63)%
Bypass1/6792%(84-97)%1/2387%(59-91)%---
In situ6/90452.21%(49-55)%27/59886.79%(84-89)%19/168365.18%(63-67)%
Pushback---1/5983%(72-91)%---
Other---11/19688%(81-93)%10/69870%(57-82)%
URS
All forms101/2987589.42%(89-90)%38/1187992.53%(92-93)%31/561983.25%(82-84)%
Flexible6/48194.59%(92-96)%2/8197.5%(91-99)%---
Mixed flexible---7/20987%(81-92)%5/9481%(67-92)%
Rigid26/643084.99%(83-85)%20/171587.35%(86-89)%16/164171.48%(69-74)%
Semi-rigid45/998491.86%(91-92)%6/232969.35%(95-97)%7/106490.79%(89-92)%

Abbreviations

ACOGAmerican College of Obstetrics and Gynecology
ASAAmerican Society of Anesthesiologists
AUAAmerican Urological Association
CBCComplete blood count
CCTControlled clinical trial
COIConflict of interest
CTComputed tomography
EHLElectrohydraulic lithotripsy
GOCGuidelines Oversight Committee
INRInternational normalized ration
IPSSInternational Prostate Symptom Score
IVPIntravenous pyelogram
IVUIntravenous urogram
J&EJudicial & Ethics Committee
NSAIDNon-steroidal anti-inflammatory agent
METMedical expulsive therapy
MRMagnetic resonance
PCNLPercutaneous nephrolithotomy
PGCPractice Guidelines Committee
PTProthrombin time
PTTPartial thromboplastin time
QoLQuality of life
RCTRandomized controlled trial
SIRSociety of Interventional Radiology
SWLShock-wave lithotripsy
ULRUpdate literature review
UPJUreteropelvic junction
URSUreteroscopy
USUltrasound
UTIUrinary tract infection
VAPSVisual Analogue Pain Scale

Tools and Resources

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