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## Complete Summary

#### GUIDELINE TITLE

Guidelines on neurogenic lower urinary tract dysfunction.

#### BIBLIOGRAPHIC SOURCE(S)

Stohrer M, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G,
Pannek J, Radziszewski P, Wyndaele JJ. Guidelines on neurogenic lower
urinary tract dysfunction. Arnhem, The Netherlands: European Association
of Urology (EAU); 2008 Mar. 60 p. \[470 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [December 04, 2007, Desmopressin Acetate (DDAVP, DDVP, Minirin, &
    Stimate)](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Desmopressin):
    New information has been added to the existing boxed warning in
    Desmopressin\'s prescribing information about potential increased
    risk for severe hyponatremia and seizures.

### COMPLETE SUMMARY CONTENT

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

### SCOPE

#### DISEASE/CONDITION(S)

Neurogenic lower urinary tract dysfunction

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Risk Assessment\
Treatment

#### CLINICAL SPECIALTY

Neurology\
Surgery\
Urology

#### INTENDED USERS

Managed Care Organizations\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide useful information for clinical practitioners on the
incidence, definitions, diagnosis, therapy, and follow-up observation of
the condition of neurogenic lower urinary tract dysfunction (NLUTD)

#### TARGET POPULATION

Patients with lower urinary tract dysfunction resulting from neurologic
problems

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Assessment**

1.  Assessment of risk factors and epidemiology

2.  Classification of neurogenic lower urinary tract dysfunction (NLUTD)

3.  General and specific (urinary, bowel, sexual, neurological) medical
    history

4.  General and neuro-urological physical examination

5.  Urodynamic assessment (bladder diary, free uroflometry, filling
    cystometry, detrusor leak point pressure, pressure flow study,
    electromyography, urethral pressure measurement, video and
    ambulatory urodynamics, provocative tests during urodynamic studies)

6.  Assessment of quality of life

**Treatment/Management**

1.  Non-invasive conservative treatment

    -   Assisted bladder emptying

    -   Lower urinary tract rehabilitation

    -   Drug treatment (anticholinergics, oxybutynin, propiverine,
        darifenacin, solifenacin, phosphodiesterase inhibitors,
        desmopressin)

    -   Electrical neuromodulation, pelvic floor muscle exercise (PFME)

    -   External appliances

2.  Minimal invasive treatment

    -   Catheterization

    -   Intravesical drug treatment (anticholinergics, vanilloids,
        capsaicin, resiniferatoxin)

    -   Intravesical electrostimulation

    -   Botulinum toxin injections

    -   Bladder neck and urethral procedures

3.  Surgery

    -   Urethral and bladder neck procedures

    -   Detrusor myectomy

    -   Denervation, deafferentation, neurostimulation, neuromodulation

    -   Bladder covering by striated muscle

    -   Bladder augmentation or substitution

    -   Urinary diversion

4.  Treatment of vesico-ureteral reflux

5.  Follow-up schedule

#### MAJOR OUTCOMES CONSIDERED

-   Quality of life/patient satisfaction

-   Frequency of urinary tract infections and other morbidity from
    procedures

-   Rate of improvement in urinary continence and restoration of lower
    urinary tract function

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

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

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

Up until 2007, the main strategy was to rely on the guidelines group
members\' knowledge and expertise on the current literature assuming
that all, or almost all, relevant information would be captured.

In updates produced from 2008 onwards, a structured literature search
will be performed for all guidelines but this search will be limited to
randomized controlled trials and meta-analyses, covering at least the
past three years, or up until the date of the latest text update if this
exceeds the three-year period. Other excellent sources to include are
other high-level evidence, Cochrane review and available high-quality
guidelines produced by other expert groups or organizations. If there
are no high-level data available, the only option is to include
lower-level data. The choice of literature will be guided by the
expertise and knowledge of the Guidelines Working Group.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### 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**

**1a** Evidence obtained from meta-analysis of randomized trials

**1b** Evidence obtained from at least one randomized trial

**2a** Evidence obtained from one well-designed controlled study without
randomization

**2b** Evidence obtained from at least one other type of well-designed
quasi-experimental study

**3** Evidence obtained from well-designed non-experimental studies,
such as comparative studies, correlation studies and case reports

**4** Evidence obtained from expert committee reports or opinions or
clinical experience of respected authorities

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

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

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

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

-   The first step in the European Association of Urology (EAU)
    guidelines procedure was to define the main topic.

-   The second step was to establish a working group. The working groups
    comprise about 4-8 members, from several countries. Most of the
    working group members are academic urologists with a special
    interest in the topic. Specialists from other medical fields
    (radiotherapy, oncology, gynaecology, anaesthesiology, etc.) are
    included as full members of the working groups as needed. In
    general, general practitioners or patient representatives are not
    part of the working groups. Each member is appointed for a four-year
    period, renewable once. A chairman leads each group.

-   The third step is to collect and evaluate the underlying evidence
    from the published literature.

-   The fourth step is to structure and present the information. All
    main recommendations are summarized in boxes and the strength of the
    recommendation is clearly marked in three grades (A-C), depending on
    the evidence source upon which the recommendation is based. Every
    possible effort is made to make the linkage between the level of
    evidence and grade of recommendation as transparent as possible.

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

**Grades of Recommendation**

A.  Based on clinical studies of good quality and consistency addressing
    the specific recommendations and including at least one randomized
    trial

B.  Based on well-conducted clinical studies, but without randomized
    clinical trials

C.  Made despite the absence of directly applicable clinical studies of
    good quality

#### COST ANALYSIS

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

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The Appraisal of Guidelines for Research and Evaluation (AGREE)
instrument was used to analyse and assess a range of specific attributes
contributing to the validity of a specific clinical guideline.

The AGREE instrument, to be used by two to four appraisers, was
developed by the AGREE collaboration
([www.agreecollaboration.org](http://www.agreecollaboration.org/)) using
referenced sources for the evaluation of specific guidelines. (See the
\"Availability of Companion Documents\" field for further methodology
information).

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Definitions for the levels of evidence (1a-4) and grades of
recommendation (A-B) are provided at the end of the \"Major
Recommendations\" field.

**Classification of Neurogenic Lower Urinary Tract Dysfunction (NLUTD)**

The Madersbacher classification system (Wyndaele et al., 2005;
Madersbacher, 1990) (see Figure 2.1 in the original guideline document)
is recommended for clinical practice (**Grade of recommendation: B**).

**Diagnosis**

**History**

1.  An extensive general history is mandatory, concentrating on past and
    present symptoms and conditions for urinary, bowel, sexual, and
    neurological functions, and on general conditions that might impair
    any of these.

2.  Special attention should be paid to the possible existence of alarm
    signs, such as pain, infection, haematuria, fever, etc., that
    warrant further specific diagnosis.

3.  A specific history should be taken for each of the four mentioned
    functions.

**Physical Examination**

1.  Individual patient handicaps should be acknowledged in planning
    further investigations.

2.  The neurological status should be described as completely as
    possible. Sensations and reflexes in the urogenital area must all be
    tested.

3.  The anal sphincter and pelvic floor functions must be tested
    extensively.

4.  Urinalysis, blood chemistry, voiding diary, residual and free
    flowmetry, incontinence quantification and urinary tract imaging
    should be performed.

**Urodynamics and Uro-neurophysiology**

1.  Urodynamic investigation is necessary to document the (dys-)function
    of the lower urinary tract (LUT) (**Grade of recommendation: A**).

2.  The recording of a bladder diary is advisable (**Grade of
    recommendation: B**).

3.  Non-invasive testing is mandatory before invasive urodynamics is
    planned (**Grade of recommendation: A**).

4.  Video-urodynamics is the gold standard for invasive urodynamics in
    patients with NLUTD. If this is available, then a filling cystometry
    continuing into a pressure flow study should be performed (**Grade
    of recommendation: A**).

5.  A physiological filling rate and body-warm saline must be used
    (**Grade of recommendation: A**).

6.  Specific uro-neurophysiological tests are elective procedures
    (**Grade of recommendation: C**).

**Treatment**

**Non-invasive Conservative Treatment**

*Conclusions*

-   Long-term efficacy and safety of anticholinergic therapy for
    neurogenic detrusor overactivity (NDO) is well documented (**Level
    of evidence: 1a, Grade of recommendation: A**).

-   A combination of therapies is often considered to maximize outcomes
    for NDO (**Level of evidence: 1a, Grade of recommendation: A**).

-   There is no drug with evidence of efficacy for underactive detrusor
    (**Level of evidence: 2a, Grade of recommendation: B**).

-   Alpha-blockers have been partly successful for decreasing bladder
    outlet resistance and autonomic dysreflexia prophylaxis in spinal
    cord injury (SCI) patients (**Level of evidence: 2a, Grade of
    recommendation: B**).

-   There is a lack of prospective randomized controlled studies in the
    medical management of NLUTD.

*Guidelines for Non-Invasive Conservative Treatment*

1.  The first aim of any therapy is the protection of the upper urinary
    tract.

2.  The mainstay of treatment for overactive detrusor is anticholinergic
    drug therapy (**Level of evidence: 1, Grade of recommendation: A**).

3.  Lower urinary tract rehabilitation may be effective in selected
    cases.

4.  A condom catheter or pads may reduce urinary incontinence to a
    socially acceptable situation.

5.  Any method of assisted bladder emptying should be used with the
    greatest caution (**Grade of recommendation: A**).

**Catheterization**

1.  Intermittent catheterization (IC) is the standard treatment for
    patients who are unable to empty their bladder (**Level of evidence:
    2, Grade of recommendation: A**).

2.  Patients should be well instructed in the technique and risks of IC.

3.  Aseptic IC is the method of choice (**Level of evidence: 2, Grade of
    recommendation: B**).

4.  The catheter size should be 12-14 Fr (**Grade of recommendation:
    B**).

5.  The frequency of IC is 4 to 6 times per day (**Grade of
    recommendation: B**).

6.  The bladder volume should remain below 400 mL (**Grade of
    recommendation: B**).

7.  Indwelling transurethral and suprapubic catheterization should be
    used only exceptionally, under close control, and the catheter
    should be changed frequently. Silicone catheters are preferred and
    should be changed every 2 to 4 weeks, while (coated) latex catheters
    need to be changed every 1 to 2 weeks. (**Grade of recommendation:
    A**).

**Minimal Invasive Treatment**

1.  See the guidelines for catheterization above.

2.  Botulinum toxin injection in the detrusor is the most effective
    minimally invasive treatment to reduce neurogenic detrusor
    overactivity (**Level of evidence: 1, Grade of recommendation: A**).

3.  Sphincterotomy is the standard treatment for detrusor sphincter
    dyssynergia (DSD) (**Level of evidence: 2, Grade of recommendation:
    A**).

4.  Bladder neck incision is effective in a fibrotic bladder neck
    (**Level of evidence: 3, Grade of recommendation: B**).

**Surgical Treatment**

1.  *Detrusor*

    -   Overactive

        -   Detrusor myectomy is an acceptable option for the treatment
            of overactive bladder when more conservative approaches have
            failed. It is limited invasive and has minimal morbidity
            (**Level of evidence: 2, Grade of recommendation: B**).

        -   Sacral rhizotomy with sacral anterior root stimulation
            (SARS) in complete lesions and sacral neuromodulation in
            incomplete lesions are effective treatments in selected
            patients (**Level of evidence: 2, Grade of recommendation:
            B**).

        -   Bladder augmentation is an acceptable option for decreasing
            detrusor pressure whenever less invasive procedures have
            failed. For the treatment of a severely thick or fibrotic
            bladder wall, a bladder substitution might be considered
            (**Level of evidence: 2, Grade of recommendation: B**).

    -   Underactive

        -   SARS with rhizotomy and sacral neuromodulation are effective
            in selected patients (**Level of evidence: 2, Grade of
            recommendation: B**).

        -   Restoration of a functional bladder by covering with
            striated muscle is still experimental (**Level of evidence:
            4**).

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2.  *Urethra*

    -   Overactive (DSD): refer to guidelines for minimal invasive
        treatment above

    -   Underactive

        -   The placement of a urethral sling is an established
            procedure (**Level of evidence: 2, Grade of recommendation:
            B**).

        -   The artificial urinary sphincter is very effective (**Level
            of evidence: 2, Grade of recommendation: B**).

        -   Transposition of the gracilis muscle is still experimental
            (**Level of evidence: 4**).

**Quality of Life (QoL)**

1.  Assess QoL to evaluate lower urinary tract symptoms (LUTS) in
    neurogenic patients and during any type of treatment for neurogenic
    bowel dysfunction (**Level of evidence 2a, Grade of recommendation:
    B**).

2.  Available tools are: Qualiveen, a specific tool for spinal cord
    lesion and multiple sclerosis patients, Visual Analogue Scale (VAS)
    for bother. However, generic (SF-36) or specific tools for
    incontinence (I-QOL) questionnaires could be used too. (**Level of
    evidence: 2a, Grade of recommendation: B**).

3.  There is a lack of disease-specific outcome measures assessing
    health-related QoL in patients with NLUTD.

**Follow-Up**

1.  Possible urinary tract infection (UTI) checked by the patient (dip
    stick).

2.  Urinalysis every second month.

3.  Upper urinary tract, bladder morphology, and residual urine every 6
    months (ultrasound).

4.  Physical examination, blood chemistry, and urine laboratory every
    year.

5.  Detailed specialist investigation every 1 to 2 years and on demand
    when risk factors emerge. The investigation is specified according
    to the patient\'s actual risk profile, but should in any case
    include a video-urodynamic investigation and should be performed in
    a leading neuro-urological centre.

6.  All of the above should be more frequent if the neurological
    pathology or the NLUTD status demands this.

**Definitions**:

**Levels of Evidence**

**1a** Evidence obtained from meta-analysis of randomized trials

**1b** Evidence obtained from at least one randomized trial

**2a** Evidence obtained from one well-designed controlled study without
randomization

**2b** Evidence obtained from at least one other type of well-designed
quasi-experimental study

**3** Evidence obtained from well-designed non-experimental studies,
such as comparative studies, correlation studies and case reports

**4** Evidence obtained from expert committee reports or opinions or
clinical experience of respected authorities

**Grades of Recommendation**

A.  Based on clinical studies of good quality and consistency addressing
    the specific recommendations and including at least one randomized
    trial

B.  Based on well-conducted clinical studies, but without randomized
    clinical trials

C.  Made despite the absence of directly applicable clinical studies of
    good quality

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=12527)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for selected
recommendations (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate diagnosis and management of neurogenic lower urinary tract
dysfunction

#### POTENTIAL HARMS

-   Drug therapy carries the risk of side effects.

-   Indwelling transurethral catheterization and, to a lesser extent,
    suprapubic cystostomy are significant and early risk factors for
    urinary tract infection (UTI) and other complications.

-   Secondary narrowing of the bladder neck may occur with
    sphincterectomy, for which combined bladder neck incision might be
    considered.

-   Increasing the bladder outlet resistance has the inherent risk of
    causing high intravesical pressure during the filling, which may
    become even higher during the voiding phase.

-   The continent stoma is created following various techniques. All of
    them, however, do show frequent complications, including leakage or
    stenosis.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Because of the risk of developing high intravesical pressure, the penile
clamp is absolutely contraindicated.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The purpose of this text is not to be proscriptive in the way a
    clinician should treat a patient but rather to provide access to the
    best contemporaneous consensus view on the most appropriate
    management currently available. European Association of Urology
    (EAU) guidelines are not meant to be legal documents but are
    produced with the ultimate aim to help urologists with their
    day-to-day practice.

-   The EAU believe that producing validated best practice in the field
    of urology is a very powerful and efficient tool in improving
    patient care. It is, however, the expertise of the clinician which
    should determine the needs of their patients. Individual patients
    may require individualized approaches which take into account all
    circumstances and treatment decisions often have to be made on a
    case-by-case basis.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

The European Association of Urology (EAU) Guidelines long version
(containing all 19 guidelines) is reprinted annually in one book. Each
text is dated. This means that if the latest edition of the book is
read, one will know that this is the most updated version available. The
same text is also made available on a CD (with hyperlinks to PubMed for
most references) and posted on the EAU websites Uroweb and Urosource
([www.uroweb.org/professional-resources/guidelines/](http://www.uroweb.org/professional-resources/guidelines/)
& <http://www.urosource.com/diseases/>).

Condensed pocket versions, containing mainly flow-charts and summaries,
are also printed annually. All these publications are distributed free
of charge to all (more than 10,000) members of the Association. Abridged
versions of the guidelines are published in European Urology as original
papers. Furthermore, many important websites list links to the relevant
EAU guidelines sections on the association websites and all, or
individual, guidelines have been translated to some 15 languages.

#### IMPLEMENTATION TOOLS

Pocket Guide/Reference Cards\
Quick Reference Guides/Physician Guides

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

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

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Stohrer M, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G,
Pannek J, Radziszewski P, Wyndaele JJ. Guidelines on neurogenic lower
urinary tract dysfunction. Arnhem, The Netherlands: European Association
of Urology (EAU); 2008 Mar. 60 p. \[470 references\]

#### ADAPTATION

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

#### DATE RELEASED

2008 Mar

#### GUIDELINE DEVELOPER(S)

European Association of Urology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

European Association of Urology

#### GUIDELINE COMMITTEE

Neurogenic Lower Urinary Tract Dysfunction Guidelines Writing Panel

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: M.Stöhrer; D. Castro-Diaz; E. Chartier-Kastler; G. Del
Popolo; G. Kramer; J. Pannek; P. Radziszewski; J-J. Wyndaele

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

All members of the Neurogenic Lower Urinary Tract Dysfunction guidelines
writing panel have provided disclosure statements of all relationships
which they have and which may be perceived as a potential source of
conflict of interest. The information is kept on file in the European
Association of Urology (EAU) database. This guidelines document was
developed with the financial support of the EAU. No external sources of
funding and support have been involved. The EAU is a non-profit
organisation and funding is limited to administrative assistance,
travel, and meeting expenses. No honoraria or other reimbursements have
been provided.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[European Association of Urology Web
site](http://www.uroweb.org/nc/professional-resources/guidelines/online/).

Print copies: Available from the European Association of Urology, PO Box
30016, NL-6803, AA ARNHEM, The Netherlands.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   EAU guidelines office template. Arnhem, The Netherlands: European
    Association of Urology (EAU); 2007. 4 p.

-   The European Association of Urology (EAU) guidelines methodology: a
    critical evaluation. Arnhem, The Netherlands: European Association
    of Urology (EAU); 18 p.

-   Guidelines on neurogenic lower urinary tract dysfunction. 2008,
    Ultra short pocket guidelines. Arnhem, The Netherlands: European
    Association of Urology (EAU); 2008 Mar. 13 p.

Print copies: Available from the European Association of Urology, PO Box
30016, NL-6803, AA ARNHEM, The Netherlands.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on July 2, 2008. The
information was verified by the guideline developer on November 11,
2008.

#### COPYRIGHT STATEMENT

This summary is based on the original guideline, which is subject to the
guideline developer\'s copyright restrictions.

Downloads are restricted to one download and print per user, no
commercial usage or dissemination by third parties is allowed.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 12/8/2008