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## Complete Summary

#### GUIDELINE TITLE

2007 guideline for the management of ureteral calculi.

#### BIBLIOGRAPHIC SOURCE(S)

EAU/AUA Nephrolithiasis Guideline Panel. Guideline for the management of
ureteral calculi. Baltimore (MD): American Urological Association
Education and Research, Inc., European Association of Urology; 2007. 61
p. \[92 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American Urological
Association (AUA), Ureteral Stones Guidelines Panel. Report on the
management of ureteral calculi. Baltimore (MD): American Urological
Association, Inc; 1997 Sep. 72 p. (Clinical practice guidelines; no.
9/97)

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Ureteral stones (ureteral calculi, ureterolithiasis, nephrolithiasis)

#### GUIDELINE CATEGORY

Management\
Treatment

#### CLINICAL SPECIALTY

Pediatrics\
Surgery\
Urology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To provide medical practitioners with a current understanding of the
principles and strategies for the management of ureteral calculi

#### TARGET POPULATION

Adult and pediatric patients with ureteral calculi

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Management**

1.  Observation with periodic imaging studies

2.  Antibiotic treatment of bacteriuria

3.  Patient counseling

4.  Urgent decompression of the collecting system with percutaneous
    drainage or ureteral stenting in septic patients

**Treatment**

1.  Medical expulsive therapy (MET), e.g.,: alpha blockers (tamsulosin,
    terazosin, doxazosin) -- preferred agents; calcium channel blockers
    (nifedipine); adjunctive corticosteroids

2.  Shock-wave lithotripsy (SWL), e.g.,:

    -   SWL with pushback

    -   SWL with stent or catheter bypass\*

    -   SWL in situ

3.  Ureteroscopy (URS)\*: flexible vs. rigid or semirigid URS

4.  Stenting after uncomplicated URS (optional)

5.  Percutaneous antegrade URS in selected cases

6.  Laparoscopic and open surgery

**\*Note**: Extraction with a basket without endoscopic visualization of
the stone (blind basketing) and routine stenting as part of SWL were
considered but not recommended.

#### MAJOR OUTCOMES CONSIDERED

-   Spontaneous passage

-   Stone-free rates (stratified by overall and pediatric population,
    stone size and location, and type of treatment)

-   Procedure counts (stratified by overall and pediatric population,
    stone size and location, procedure type \[primary, secondary,
    adjunctive\], and type of treatment)

-   Complication occurrence rates in the overall population (stratified
    by treatment and stone size and location)

-   Complication occurrence rates in pediatric population (stratified by
    treatment)

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**Literature Search and Data Extraction**

The review of the evidence began with a literature search and data
extraction between April 2003 and February 2006 (see Appendix 4 of the
original guideline document). 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 (see Appendix 5 in the
original guideline document). 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.

#### NUMBER OF SOURCE DOCUMENTS

A total of 244 of the articles were initially accepted, although some
were later rejected from inclusion in both the efficacy and
complications analyses. Articles excluded from evidence combination
remained candidates as references to support the discussion in the text
of the Guideline.

See Appendices 6 and 7 in the original guideline document for a complete
list of articles.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

**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

#### METHODS USED TO ANALYZE THE EVIDENCE

Meta-Analysis\
Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

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,
which provides methods for analyzing data from studies that are not
randomized controlled trials (RCTs). The Fast\*Pro computer software 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
(CI). 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
confidence intervals reflect available data, the probabilities for
certain outcomes can vary widely from study to study within one
treatment modality. In addition, the fact that data from only a few
randomized controlled trials 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.

Refer to Chapter 2 of the original guideline document for more detailed
information on the methods used to analyze the evidence.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

After the evidence was combined and outcome tables were produced, the
Panel met to review the results and identify anomalies. Additional
teleconferences were held to review updates to the outcomes tables based
on the problems identified. From the evidence in the outcome tables and
expert opinion, the Panel drafted the treatment guideline.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

A \"standard\" has the least flexibility as a treatment policy, a
\"recommendation\" has significantly more flexibility, and an \"option\"
is even more flexible. These three levels of flexibility are defined as
follows:

**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.

**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.

**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.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The draft of the guideline 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 American Urological Association (AUA) and
the Guidelines Office of the European Association of Urology (EAU) and
then forwarded to the AUA Board of Directors and the EAU Board for final
approval.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Levels of evidence (**Ia-IV**), grades of the guideline statements
(**Standard, Recommendation, Option**), and the index patient are
defined at the end of the \"Major Recommendations\" field.

**Treatment Guidelines for the Index Patient**

**For All Index Patients**

**Standard**: Patients with bacteriuria should be treated with
appropriate antibiotics. \[Based on Panel consensus/**Level IV**\]

**Standard**: Stone extraction with a basket without endoscopic
visualization of the stone (blind basketing) should not be performed.
\[Based on Panel consensus/**Level IV**\]

**For Ureteral Stones \<10 mm**

**Option**: In a patient who has a newly diagnosed ureteral stone \<10
mm and whose symptoms are controlled, observation with periodic
evaluation is an option for initial treatment. Such patients may be
offered an appropriate medical therapy to facilitate stone passage
during the observation period. \[Based on review of the data and panel
opinion/**Level IA**\]

**Standard**: Patients should be counseled on the attendant risks of
medical expulsive therapy (MET) including associated drug side effects
and should be informed that it is administered for an \"off label\" use.
\[Based on Panel consensus/**Level IV**\]

**Standard**: Patients who elect for an attempt at spontaneous passage
or MET should have well-controlled pain, no clinical evidence of sepsis,
and adequate renal functional reserve. \[Based on Panel
consensus/**Level IV**\]

**Standard**: Patients should be followed with periodic imaging studies
to monitor stone position and to assess for hydronephrosis. \[Based on
Panel consensus/**Level IV**\]

**Standard**: Stone removal is indicated in the presence of persistent
obstruction, failure of stone progression, or in the presence of
increasing or unremitting colic. \[Based on Panel consensus/**Level
IV**\]

**For Ureteral Stones \>10 mm**

*For Patients Requiring Stone Removal*

**Standard**: A patient must be informed about the existing active
treatment modalities, including the relative benefits and risks
associated with each modality. \[Based on Panel consensus/**Level IV**\]

**Recommendation**: For patients requiring stone removal, both
shock-wave lithotripsy (SWL) and ureteroscopy (URS) are acceptable
first-line treatments. \[Based on review of the data and Panel
consensus/**Level IA-IV**\]

**Recommendation**: Routine stenting is not recommended as part of SWL.
\[Based on Panel consensus/**Level III**\]

**Option**: Stenting following uncomplicated URS is optional. \[Based on
Panel consensus/**Level IA**\]

**Option**: Percutaneous antegrade ureteroscopy is an acceptable
first-line treatment in select cases. \[Based on Panel consensus/**Level
III**\]

**Option**: Laparoscopic or open surgical stone removal may be
considered in rare cases where SWL, URS, and percutaneous URS fail or
are unlikely to be successful. \[Based on Panel consensus/**Level
III**\]

**Recommendations for the Pediatric Patient**

**Option**: Both SWL and URS are effective in this population. Treatment
choices should be based on the child\'s size and urinary tract anatomy.
The small size of the pediatric ureter and urethra favors the less
invasive approach of SWL. \[Based on review of data and Panel
consensus/**Level III**\]

**Recommendations for the Nonindex Patient**

**Standard**: For septic patients with obstructing stones, urgent
decompression of the collecting system with either percutaneous drainage
or ureteral stenting is indicated. Definitive treatment of the stone
should be delayed until sepsis is resolved. \[Based on Panel
consensus/**Level III**\]

**Definitions**:

**Levels of Evidence**

**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

**Grades of Guideline Statements**

**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.

**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.

**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.

**Index Patient**

In constructing these guidelines, an \"index patient\" was defined to
reflect the typical individual with a ureteral stone whom a urologist
treats. The following definition was created.

The index patient is a nonpregnant adult with a unilateral
noncystine/nonuric acid radiopaque ureteral stone without renal calculi
requiring therapy whose contralateral kidney functions normally and
whose medical condition, body habitus, and anatomy allow any one of the
treatment options to be undertaken.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\" field).

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate selection of particular treatment modalities for ureteral
calculi, taking into consideration such factors as stone size, and
location

#### POTENTIAL HARMS

The following are the most relevant treatment complications:

1.  Sepsis

2.  Steinstrasse

3.  Stricture

4.  Ureteral injury

5.  Urinary tract infection (UTI)

Serious complications, including death and loss of kidney, are rare.

Refer to Chapter 3 and Tables 5 and 6 in the original guideline document
for more information on complications associated with shock-wave
lithotripsy (SWL) and ureteroscopy (URS).

Although highly effective, laparoscopic ureterolithotomy is not a
first-line therapy in most cases because of its invasiveness, attendant
longer recovery time, and the greater risk of associated complications
compared to SWL and URS.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   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.

-   Some of the medical therapies currently employed in the management
    of ureteral calculi have not been approved by the US Food and Drug
    Administration for this specific indication. Thus, doses and dosing
    regimens may deviate from that employed for the Food and Drug
    Administration-approved indications, and this difference should be
    considered in the risk-versus-benefit assessment.

-   This document provides guidance only, and does not establish a fixed
    set of rules or define the legal standard of care. As medical
    knowledge expands and technology advances, this guideline will
    change. Today it represents not absolute mandates but provisional
    proposals or recommendations for treatment under the specific
    conditions described. For all these reasons, the guideline does not
    preempt physician judgment in individual cases. Also, treating
    physicians must take into account variations in resources, and in
    patient tolerances, needs and preferences. Conformance with the
    guideline reflected in this document cannot guarantee a successful
    outcome.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

**Dissemination**

The guideline is posted on the American Urological Association Web site
[www.auanet.org](http://www.auanet.org/) and on the European Association
of Urology Web site [www.uroweb.org](http://www.uroweb.org/). Chapter 1
will be published in *The Journal of Urology* and in *European Urology*.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness\
Patient-centeredness\
Safety

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

EAU/AUA Nephrolithiasis Guideline Panel. Guideline for the management of
ureteral calculi. Baltimore (MD): American Urological Association
Education and Research, Inc., European Association of Urology; 2007. 61
p. \[92 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1997 Sep (revised 2007 Dec)

#### GUIDELINE DEVELOPER(S)

American Urological Association Education and Research, Inc. - Medical
Specialty Society\
European Association of Urology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

The American Urological Association (AUA) and the European Association
of Urology provided the funding.

#### GUIDELINE COMMITTEE

EAU/AUA Nephrolithiasis Guideline Panel and Consultants

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Names of Panel Members*: Glenn M. Preminger, MD, (*Chair*); Hans-Göran
Tiselius, MD, PhD, (*Co-Chair*); Dean G. Assimos, MD, (*Vice Chair*);
Peter Alken, MD, PhD; Colin Buck, MD, PhD; Michele Gallucci, MD, PhD;
Thomas Knoll, MD, PhD; James E. Lingeman, MD; Stephen Y. Nakada, MD;
Margaret Sue Pearle, MD, PhD; Kemal Sarica, MD, PhD; Christian Türk, MD,
PhD; J. Stuart Wolf, Jr., MD

*Consultants*: Hanan S. Bell, PhD; Patrick M. Florer

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Panel members received no remuneration for their work. Each member of
the Practice Guidelines Committee and of the Panel furnished a current
conflict of interest disclosure to the American Urological Association
(AUA).

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American Urological
Association (AUA), Ureteral Stones Guidelines Panel. Report on the
management of ureteral calculi. Baltimore (MD): American Urological
Association, Inc; 1997 Sep. 72 p. (Clinical practice guidelines; no.
9/97)

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [American Urological Association
(AUA) Web site](http://www.auanet.org/guidelines/uretcal07.cfm) and the
[European Association of Urology (EAU) Web
site](http://www.uroweb.org/nc/professional-resources/guidelines/online/).

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on September 1, 1998. It was verified
by the guideline developer on December 1, 1998. This summary was updated
by ECRI Institute on March 21, 2008. The updated information was
verified by the guideline developer on April 1, 2008.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is
copyrighted by the American Urological Association Education and
Research, Inc. (AUA).

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008