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## Complete Summary

#### GUIDELINE TITLE

Bladder management for adults with spinal cord injury: a clinical
practice guideline for health-care providers.

#### BIBLIOGRAPHIC SOURCE(S)

Consortium for Spinal Cord Medicine. Bladder management for adults with
spinal cord injury: a clinical practice guideline for health care
providers. Washington (DC): Paralyzed Veterans of America; 2006 Aug. 50
p. \[108 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### 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)

Neurogenic bladder as a result of spinal cord injury

#### GUIDELINE CATEGORY

Management\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Physical Medicine and Rehabilitation

#### INTENDED USERS

Advanced Practice Nurses\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide both individuals with spinal cord injury and the health-care
providers who advise them with the best and most up-to-date information
on the wide variety of bladder management techniques available to them

#### TARGET POPULATION

Adult patients with spinal cord injuries

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Management/Treatment**

1.  Intermittent catheterization

2.  Crede and Valsalva

3.  Indwelling catheterization

4.  Reflex voiding

5.  Alpha-blockers

6.  Botulinum toxin injection

7.  Endourethral stents

8.  Transurethral sphincterotomy

9.  Electrical stimulation and posterior sacral rhizotomy

10. Bladder augmentation

11. Continent urinary diversion

12. Urinary diversion

13. Cutaneous Ileovesicostomy

#### MAJOR OUTCOMES CONSIDERED

-   Efficacy and safety of each intervention

-   Urodynamic outcomes

-   Economic (utilization) outcomes

### 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

**Methodology**

Metaworks, Inc. performed a systematic review of the literature
published since 1993 that describes bladder management after traumatic
spinal cord injuries in the adult population. The focus of the review
was the evaluation of various modalities of bladder management intended
to maintain and preserve a functional urinary tract. In general, the
review procedures followed the best methods used in the evolving science
of systematic review research. Systematic review is a scientific
technique designed to minimize bias and random error by first conducting
a comprehensive search of the literature and then use a preplanned
process for study selection.

**Literature Search**

The literature search included both electronic and manual components.
Medline (via PubMed) was searched back to 1993 for citations using the
following Medical Subject Heading \[MeSH\] terms and keywords:

1.  Bladder, neurogenic \[MeSH\] OR neurogenic bladder OR neuropathic
    bladder.

2.  Spinal cord injuries \[MeSH\] OR paraplegia \[MeSH\] OR quadriplegia
    \[MeSH\] OR tetraplegia.

3.  Urination disorders (MeSH\] OR urinary OR urologic OR bladder OR
    kidney calculi \[MeSH\] OR hydronephrosis \[MeSH\] OR kidney failure
    \[MeSH\] OR vesicoureteral reflux \[MeSH\] OR renal failure.

4.  #2 AND #3.

5.  #1 OR #4 limits: publication date from 1993 to November 30, 2001,
    English, human.

In addition, two strategies were used to identify papers that may not
have been indexed on Medline by the time of the search cutoff date. The
PubMed search included a keyword search for the prior 6 months, using
terms indicating spinal cord injury and urologic management, with no
limits; and Current Contents was searched for the past year, using
similar search terms.

The Cochrane Library and National Guidelines Clearing House were
searched for any recent systematic reviews or clinical guidelines on the
subject, which could have been sources for further references. A manual
check of the reference lists of all accepted papers and of recent
reviews was performed to supplement the above electronic searches.
Abstracts from the electronic search were downloaded and evaluated using
the literature review process described below.

The last step was to search Medline back to 1980 using the same search
strategy in order to find relevant reviews and expert opinion papers on
bladder management in individuals with SCI.

**Study Selection**

To be eligible for inclusion in this review, studies had to meet the
following criteria.

*Exclusion Criteria*

Studies were excluded if they contained the following elements:

-   Abstracts, letters, comments, editorials

-   Animal and in vitro studies

-   Pharmacokinetic and pharmacodynamic studies

-   Language other than English

-   Publication prior to 1993

*Inclusion Criteria*

Studies were included if they met the following criteria and did not
meet any exclusion criteria:

-   Any of the following study designs: interventional or observational

-   Any geographic location

-   Condition of interest: traumatic spinal cord injury in individuals
    age 13 or older

-   Study focus: bladder management

Case reports were set aside and given to the guideline development
panel, but they were not extracted for inclusion in the database. Review
articles published since 1980 were set aside for possible use in framing
the discussion of findings in the systematic review. A complete list of
these papers along with abstracts was provided to the guideline
development panel for supplemental use in developing the guidelines.

#### NUMBER OF SOURCE DOCUMENTS

71 papers were accepted for data extraction, with an additional 11
papers that were linked publications

#### 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**

I.  Evidence based on randomized controlled clinical trials (or
    meta-analysis of such trials) of adequate size to ensure a low risk
    of incorporating false-positive or false-negative results.

II. Evidence based on randomized controlled trials that were too small
    to provide level I evidence. These may have shown either positive
    trends that were not statistically significant or no trends and were
    associated with a high risk of false-negative results.

III. Evidence based on nonrandomized, controlled or cohort studies, case
     series, case-controlled studies, or cross-sectional studies.

IV. Evidence based on the opinion of respected authorities or that of
    expert committees as indicated in published consensus conferences or
    guidelines.

V.  Evidence that expressed the opinion of those individuals who were
    writing and reviewing these guidelines, based on their experience,
    knowledge of the relevant literature, and discussion with peers.

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

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

Data extraction involves the capturing of various data elements from
each study. This task was performed by one investigator using data
extraction forms (DEFs) designed specifically for this project. A second
investigator established a consensus for all extracted data, and a third
investigator arbitrated any disagreements. The consensus versions of the
DEFs were entered into MetaHub™, MetaWorks\' relational database of
clinical trials information.

After 100 percent of the entered data were validated against the
consensus DEFs and full consistency and logic checks were performed on
the database, the data were locked. After the data passed these quality
control measures, they were used to generate evidence tables, which were
delivered to the guideline development panel for review.

See the original guideline document for a list of data elements
extracted, when possible, from each accepted study.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

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

The guideline development process adopted by the Consortium for Spinal
Cord Medicine consists of twelve steps, leading to panel consensus and
organizational endorsement. After the steering committee chooses a
topic, a panel of experts is selected. Panel members must have
demonstrated leadership in the topic area through independent scientific
investigation and publication. Following a detailed explication and
specification of the topic by select steering committee and panel
members, consultant methodologists review the international literature,
prepare evidence tables that grade and rank the quality of research, and
conduct statistical meta-analyses and other specialized studies, as
needed. The panel chair then assigns specific sections of the topic to
the panel members based on their area of expertise. Writing begins on
each component using the references and other materials furnished by the
methodology support group.

After panel members complete their sections, a draft document is
generated during the first full meeting of the panel. The panel
incorporates new literature citations and other evidence-based
information not previously available. At this point, charts, graphs,
algorithms, and other visual aids, as well as a complete bibliography,
are added, and the full document is sent to legal counsel for review.

**Grading the Guideline Recommendations**

After panel members had drafted their sections of the guideline, each
recommendation was graded according to the level of scientific evidence
supporting it. The framework used by the methodology team is outlined in
\"Rating Scheme for the Strength of the Recommendations.\" It should be
emphasized that these ratings, like the evidence table ratings,
represent the strength of the supporting evidence, not the strength of
the recommendation itself. The strength of the recommendation is
indicated by the language describing the rationale.

If the literature supporting a recommendation comes from two or more
levels, the number and level of the studies are reported (e.g., in the
case of a recommendation that is supported by two studies, one a level
III, the other a level V, the \"Scientific evidence\" is indicated as
\"III/V\"). In situations in which no published literature exists,
consensus of the panel members and outside expert reviewers was used to
develop the recommendation and is indicated as \"Expert consensus.\"

**Grading of Panel Consensus**

The level of agreement with the recommendation among panel members was
assessed as either low, moderate, or strong. Each panel member was asked
to indicate his or her level of agreement on a 5-point scale, with 1
corresponding to neutrality and 5 representing maximum agreement. Scores
were aggregated across the panel members and an arithmetic mean was
calculated. This mean score was then translated into low, moderate, or
strong. A panel member could abstain from the voting process for a
variety of reasons, including, but not limited to, lack of expertise
associated with the particular recommendation.

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

**Strength of Evidence Associated with the Recommendations (Grade of
Recommendation)**

A.  The guideline recommendation is supported by one or more level I
    studies.

B.  The guideline recommendation is supported by one or more level II
    studies.

C.  The guideline recommendation is supported only by one or more level
    III, IV, or V studies.

**Levels of Panel Agreement with Recommendation (Strength of Panel
Opinion)**

Low - Mean agreement score 1.0 to less than 2.33

Moderate - Mean agreement score 2.33 to less than 3.67

Strong - Mean agreement score 3.67 to 5.0

#### COST ANALYSIS

The economic considerations for bladder management methods are outlined
in Appendix A of the original guideline document.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

After legal analysis to consider antitrust, restraint-of-trade, and
health policy matters, the draft document is reviewed by clinical
experts from each of the consortium organizations plus other select
clinical experts and consumers. The review comments are assembled,
analyzed, and entered into a database, and the document is revised to
reflect the reviewers\' comments. The draft document is distributed to
all consortium organization steering committee members. Final technical
details are negotiated among the panel chair, members of the
organizations\' boards, and expert panelists. If substantive changes are
required, the draft receives a final legal review. The document is then
ready for editing, formatting, and preparation for publication.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Rating schemes for the levels of scientific evidence (I, II, III, IV,
V), grade of recommendation (A, B, C) and the strength of panel opinion
(Low, Moderate, Strong) are defined at the end of the \"Major
Recommendations\" field.

**Intermittent Catheterization**

1.  Consider intermittent catheterization for individuals who have
    sufficient hand skills or a willing caregiver to perform the
    catheterization.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Consider avoiding intermittent catheterization in individuals with
    spinal cord injury (SCI) who have one or more of the following:

    -   Inability to catheterize themselves

    -   A caregiver who is unwilling to perform catheterization

    -   Abnormal urethral anatomy such as stricture, false passages, and
        bladder neck obstruction

    -   Bladder capacity less than 200 mL

    -   Poor cognition, little motivation, or inability or unwillingness
        to adhere to the catheterization time schedule

    -   High fluid intake regimen

    -   Adverse reaction to passing a catheter into the genital area
        multiple times a day

    -   Tendency to develop autonomic dysreflexia with bladder filling
        despite treatment

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

3.  Advise individuals with SCI of the potential for complications with
    intermittent catheterization, such as:

    -   Urinary tract infections

    -   Bladder overdistention

    -   Urinary incontinence

    -   Urethral trauma with hematuria

    -   Urethral false passages

    -   Urethral stricture

    -   Autonomic dysreflexia (in those with injuries at T6 and above)

    -   Bladder stones

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

4.  If bladder volumes consistently exceed 500 mL, adjust fluid intake,
    increase frequency of intermittent catheterization, or consider an
    alternative bladder management method.

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

5.  Institute clean intermittent catheterization teaching and training
    for individuals prior to discharge from the acute phase of
    rehabilitation.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

6.  Consider sterile catheterization for individuals with recurrent
    symptomatic infections occurring with clean intermittent
    catheterization.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

7.  Investigate and provide treatment for individuals on intermittent
    catheterization who leak urine between catheterizations.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

8.  Monitor individuals using this method of bladder management.

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

**Credé and Valsalva**

1.  Consider the use of Credé and Valsalva for individuals who have
    lower motor neuron injuries with low outlet resistance or who have
    had a sphincterotomy.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Consider avoiding Credé and Valsalva as primary methods of bladder
    emptying.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

3.  Consider avoiding Credé and Valsalva methods in individuals with:

    -   Detrusor sphincter dyssynergia

    -   Bladder outlet obstruction

    -   Vesicoureteral reflux

    -   Hydronephrosis

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

4.  Advise individuals with SCI of the potential for complications with
    Credé and Valsalva, such as:

    -   Incomplete bladder emptying

    -   High intravesical pressure

    -   Developing and/or worsening vesicoureteral reflux

    -   Developing and/or worsening hydronephrosis

    -   Abdominal bruising

    -   Possible hernia, pelvic organ prolapse, or hemorrhoids

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

**Indwelling Catheterization**

1.  Consider indwelling catheterization for individuals with:

    -   Poor hand skills

    -   High fluid intake

    -   Cognitive impairment or active substance abuse

    -   Elevated detrusor pressures managed with anticholinergic
        medications or other means

    -   Lack of success with other less invasive bladder management
        methods

    -   Need for temporary management of vesicoureteral reflux

    -   Limited assistance from a caregiver, making another type of
        bladder management not feasible

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Consider using suprapubic catheterization for individuals with:

    -   Urethral abnormalities, such as stricture, false passages,
        bladder neck obstruction, or urethral fistula

    -   Urethral discomfort

    -   Recurrent urethral catheter obstruction

    -   Difficulty with urethral catheter insertion

    -   Perineal skin breakdown as a result of urine leakage secondary
        to urethral incompetence

    -   Psychological considerations such as body image or personal
        preference

    -   A desire to improve sexual genital function

    -   Prostatitis, urethritis, or epididymo-orchitis

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

3.  Consider avoiding urethral catheterization in individuals with SCI:

    -   Immediately following acute SCI if urethral injury is suspected,
        especially after pelvic trauma (blood at the urethral meatus and
        perineal and scrotal hematomas may be indicative of urethral
        trauma)

    -   If bladder capacity is small, with forceful uninhibited
        contractions despite treatment

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

4.  Consider indwelling catheterization for individuals who are at risk
    of genitourinary complications because of elevated detrusor
    pressures.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

5.  Advise individuals of the long-term complications associated with
    indwelling catheterization, which include:

    -   Bladder stones

    -   Kidney stones

    -   Urethral erosions

    -   Epididymitis

    -   Recurrent symptomatic urinary tract infections

    -   Incontinence

    -   Pyelonephritis

    -   Hydronephrosis from bladder wall thickening or fibrosis

    -   Bladder cancer

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

6.  Conduct more frequent cystoscopic evaluations for individuals with
    chronic indwelling catheters than for those with nonindwelling
    methods of bladder management.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

7.  Consider the use of anticholinergics in individuals with suprasacral
    lesions using chronic indwelling catheterization.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

**Reflex Voiding**

1.  Consider using reflex voiding for males who demonstrate post-spinal
    shock with adequate bladder contractions and have:

    -   Sufficient hand skills to put on a condom catheter and empty the
        leg bag, or a willing caregiver

    -   Poor compliance with fluid restriction

    -   Small bladder capacity

    -   Small post-void residual volumes

    -   Ability to maintain a condom catheter in place

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

2.  Conduct a thorough urodynamic evaluation to determine whether reflex
    voiding is a suitable method for a particular individual.

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

3.  Consider not using reflex voiding as a method of bladder management
    in individuals who:

    -   Have insufficient hand skills or caregiver assistance

    -   Are unable to maintain a condom catheter in place

    -   Are female

    -   Have incomplete bladder emptying despite treatment to facilitate
        voiding

    -   Have high-pressure voiding despite treatment to facilitate
        voiding

    -   Develop autonomic dysreflexia despite treatment to facilitate
        voiding

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

4.  Advise individuals of the potential for complications with reflex
    voiding, such as:

    -   Condom catheter leakage and/or failure

    -   Penile skin breakdown from external condom catheter

    -   Urethral fistula

    -   Symptomatic urinary tract infection (UTI)

    -   Poor bladder emptying

    -   High intravesical voiding pressures

    -   Autonomic dysreflexia in those with injuries at T6 and above

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

5.  First consider the use of the following nonsurgical methods to help
    decrease detrusor sphincter dyssynergia in individuals who use
    reflex voiding as their method of bladder management:

    -   Alpha-blockers

    -   Botulinum toxin injection into the urinary sphincter mechanism

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

6.  To ensure low-pressure voiding during reflex voiding, consider the
    use of two surgical methods:

    -   Transurethral sphincterotomy

    -   Endourethral stents

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong*)

**Alpha-Blockers**

1.  Consider the use of alpha-blockers on their own or as a supplement
    to other forms of treatment, such as transurethral sphincterotomy.

> *(Scientific evidence--II/III; Grade of recommendation--B/C; Strength
> of panel opinion--Strong)*

2.  Consider avoiding alpha-blockers in individuals who have symptomatic
    hypotension.

> *(Scientific evidence--II/III; Grade of recommendation--B/C; Strength
> of panel opinion--Strong)*

3.  When first prescribing, instruct the individual to take
    alpha-blockers at night, when supine. These instructions are
    particularly important for individuals with high-level spinal cord
    injuries because of the potential for orthostatic hypotension.

> *(Scientific evidence--II/III; Grade of recommendation--B/C; Strength
> of panel opinion--Strong)*

4.  Use phosphodiesterase inhibitors with caution in individuals with a
    high-level SCI who are on alphablockers. Particular caution should
    be used if alpha-blockers and phosphodiesterase (PDE5) inhibitors
    are prescribed together.

> *(Scientific evidence--II/III; Grade of recommendation--B/C; Strength
> of panel opinion--Strong)*

5.  Advise individuals of the potential for complications of
    alpha-blockers, such as orthostatic hypotension.

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

**Botulinum Toxin Injection**

1.  Consider the use of botulinum toxin injections into the sphincter to
    help improve voiding in individuals with SCI with detrusor sphincter
    dyssynergia.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Monitor individuals after botulinum toxin injections and inform them
    that onset may be delayed up to 1 week and that the drug may lose
    its effectiveness in 3 to 6 months.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

3.  Consider avoiding the injection of botulinum toxin into the
    sphincter of SCI individuals who:

    -   Have a neuromuscular disease

    -   Have a known allergy to or previous adverse effect from
        botulinum toxin

    -   Are currently on an aminoglycoside

    -   Have insufficient hand skills or caregiver assistance

    -   Are unable to maintain a condom catheter

    -   Are female

> (*Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

4.  Advise individuals with SCI of the potential for complications of
    botulinum toxin injections into the sphincter, such as:

    -   Autonomic dysreflexia during the injection (T6 and above)

    -   Hematuria during the injection

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

5.  Consider injecting botulinum toxin into the detrusor muscle of
    individuals on intermittent catheterization with detrusor
    overactivity.

> *(Scientific evidence--I/III; Grade of recommendation--A/C; Strength
> of panel opinion--Strong)*

**Endourethral Stents**

1.  Consider endourethral stents to treat detrusor sphincter dyssynergia
    in individuals who want to reflex void and:

    -   Have insufficient hand skills or caregiver assistance to perform
        intermittent catheterization

    -   Have a repeated history of autonomic dysreflexia

    -   Experience difficult catheterization due to false passages in
        the urethra or secondary bladder neck obstruction

    -   Have inadequate bladder drainage with severe bladder wall
        changes, drop in renal function, vesicoureteral reflux, and/or
        stone disease

    -   Have prostate-ejaculatory reflux with the potential for repeated
        epididymo-orchitis

    -   Experience failure with or intolerance to anticholinergic
        medications for intermittent catheterization

    -   Experience failure with or intolerance to alpha-blockers with
        reflex voiding

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

2.  Consider the endourethral stent method of drainage as an alternative
    to transurethral sphincterotomy in individuals with SCI.

> *(Scientific evidence--II; Grade of recommendation--B; Strength of
> panel opinion--Strong)*

3.  Consider avoiding endourethral stents in individuals who:

    -   Have insufficient hand skills or caregiver assistance to manage
        a condom catheter

    -   Are unable to maintain a condom catheter

    -   Are female

    -   Have urethral abnormalities

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

4.  Advise individuals of the potential for complications of
    endourethral stents, such as:

    -   Stone encrustation

    -   Stent migration

    -   Persistence of autonomic dysreflexia

    -   Possible need for removal or replacement

    -   Difficulty with removal

    -   Possible urethral stricture after removal of stent

    -   Urethral trauma

    -   Tissue growth into the stent blocking urine flow

    -   Urethral pain

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

**Transurethral Sphincterotomy**

1.  Consider transurethral sphincterotomy (TURS) to treat detrusor
    sphincter dyssynergia in males with SCI who want to use reflex
    voiding and who:

    -   Have insufficient hand skills or caregiver assistance to perform
        intermittent catheterization

    -   Have a repeated history of autonomic dysreflexia with a
        noncompliant bladder

    -   Experience difficult catheterization due to false passages in
        the urethra or secondary bladder neck obstruction

    -   Have inadequate bladder drainage with severe bladder wall
        changes, drop in renal function, vesicoureteral reflex, and/or
        stone disease

    -   Have prostate-ejaculatory reflux with the potential for repeated
        epididymo-orchitis

    -   Experience failure with or intolerance to anticholinergic
        medications for intermittent catheterization

    -   Experience failure with or intolerance to alpha-blockers with
        reflex voiding

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Consider avoiding sphincterotomy in males with a small retractable
    penis unable to hold an external collecting device unless a penile
    implant is planned following transurethral sphincterotomy.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

3.  Advise individuals with SCI of the potential for complications of a
    sphincterotomy, such as:

    -   Significant intraoperative and perioperative bleeding

    -   Clot retention

    -   Prolonged drainage with a large diameter catheter

    -   Urethral stricture

    -   Erectile dysfunction

    -   Ejaculatory dysfunction

    -   Reoperation in 30 to 60 percent of cases

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

4.  Consider laser sphincterotomy the procedure of choice for
    transurethral sphincterotomy, depending upon the availability of
    laser equipment.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

**Electrical Stimulation and Posterior Sacral Rhizotomy**

1.  Consider electrical stimulation and posterior sacral rhizotomy in
    individuals with:

    -   High post-void residual volumes

    -   Chronic or recurrent urinary tract infection

    -   Problems with catheters

    -   Reflex incontinence

    -   Reduced bladder capacity and compliance, caused by detrusor
        hyperreflexia

    -   Intolerance of anticholinergic medication

    -   Detrusor sphincter dyssynergia

    -   Autonomic dysreflexia

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Avoid electrical stimulation combined with posterior sacral
    rhizotomy for:

    -   Individuals who have poor or absent bladder contractions

    -   Individuals who are unable to expand the bladder due to fibrosis

    -   Females who are unable to transfer or be transferred or to
        manage clothing

    -   Males who are unwilling to lose reflex erection

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

3.  Advise individuals with SCI of the potential for complications of
    posterior sacral rhizotomy, such as:

    -   Loss of reflex erection and reflex ejaculation

    -   Loss of sacral sensation

    -   Reduction of reflex defecation

    -   Transient nerve damage (rarely long term)

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

4.  Advise individuals with SCI of the potential for complications of
    electrical stimulation, such as:

    -   Contamination of the device

    -   Malfunction of the device

    -   Transient nerve damage (rarely long term)

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

**Bladder Augmentation**

1.  Consider bladder augmentation for individuals who have:

    -   Intractable involuntary bladder contractions causing
        incontinence

    -   The ability and motivation to perform intermittent
        catheterization.

    -   The desire to convert from reflex voiding to an intermittent
        catheterization program

    -   A high risk for upper tract deterioration secondary to
        hydronephrosis and/or ureterovesical reflux as a result of high
        pressure detrusor sphincter dyssynergia

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Consider bladder augmentation for females with paraplegia.

> *(Scientific evidence--None; Grade of recommendation--None; Strength
> of panel opinion--Strong)*

3.  Consider bladder augmentation for individuals who are at high risk
    for upper tract deterioration secondary to hydronephrosis and/or
    ureterovesical reflux as a result of high pressures, secondary to
    poor bladder wall compliance, and/or detrusor sphincter dyssynergia.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

4.  Avoid augmentation for individuals who have:

    -   Inflammatory bowel disease

    -   Pelvic irradiation

    -   Severe abdominal adhesions from previous surgery

    -   Compromised renal function

> *(Scientific evidence--II/III; Grade of recommendation--B/C; Strength
> of panel opinion--Strong)*

5.  Advise individuals of both the early and late complications of
    reconstructive surgery using intestinal segments.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

**Continent Urinary Diversion**

1.  Consider a continent urinary diversion for:

    -   Individuals in whom it is not feasible to augment the native
        bladder

    -   Individuals who cannot access their native urethra because of
        congenital abnormalities, spasticity, obesity, contracture, or
        tetraplegia, or who require closure of an incompetent bladder
        neck

    -   Females with tetraplegia in whom a chronic indwelling catheter
        has caused urethral erosion

    -   Males with SCI with unsalvageable bladders secondary to urethral
        fistula and sacral pressure ulcers

    -   Individuals with bladder cancer requiring cystectomy

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

**Urinary Diversion**

1.  Consider urinary diversion in the following circumstances:

    -   Lower urinary complications secondary to indwelling catheters

    -   Urethrocutaneous fistulas

    -   Perineal pressure ulcers

    -   Urethral destruction in females

    -   Hydronephrosis secondary to a thickened bladder wall

    -   Hydronephrosis secondary to vesicoureteral reflux or failed
        reimplant

    -   Bladder malignancy requiring cystectomy

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Use urinary diversion with caution in individuals who are too
    debilitated to undergo a major surgical procedure or who have one of
    the following conditions:

    -   Inflammatory bowel disease

    -   Pelvic irradiation

    -   Severe abdominal adhesions from previous surgery

    -   Compromised renal function

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

3.  Advise individuals undergoing urinary diversion of the following
    potential complications:

    -   Early complications associated with any major intestinal
        surgery, including anesthetic complications

    -   Prolonged ileus (more common in SCI)

    -   Intestinal or urinary leak

    -   Sepsis and wound infection

    -   Ureteroileal stricture

    -   Stomal stenosis

    -   Parastomal hernia

    -   Intestinal obstruction due to adhesions

    -   Urinary infection and stone disease

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

**Cutaneous Ileovesicostomy**

1.  Consider cutaneous ileovesicostomy for individuals who require
    urinary diversion with normal ureterovesical junctions.

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

2.  Be prepared to perform secondary procedures that may be needed to
    prevent urethral incontinence (for example, on the bladder neck in
    conjunction with augmentation or suprapubic cystostomy or cutaneous
    ileovesicostomy).

> *(Scientific evidence--III; Grade of recommendation--C; Strength of
> panel opinion--Strong)*

**Definitions**:

**Levels of Evidence**

I.  Evidence based on randomized controlled clinical trials (or
    meta-analysis of such trials) of adequate size to ensure a low risk
    of incorporating false-positive or false-negative results.

II. Evidence based on randomized controlled trials that were too small
    to provide level I evidence. These may have shown either positive
    trends that were not statistically significant or no trends and were
    associated with a high risk of false-negative results.

III. Evidence based on nonrandomized, controlled or cohort studies, case
     series, case-controlled studies, or cross-sectional studies.

IV. Evidence based on the opinion of respected authorities or that of
    expert committees as indicated in published consensus conferences or
    guidelines.

V.  Evidence that expressed the opinion of those individuals who were
    writing and reviewing these guidelines, based on their experience,
    knowledge of the relevant literature, and discussion with peers.

**Strength of Evidence Associated with the Recommendations (Grade of
Recommendation)**

A.  The guideline recommendation is supported by one or more level I
    studies.

B.  The guideline recommendation is supported by one or more level II
    studies.

C.  The guideline recommendation is supported only by one or more level
    III, IV, or V studies.

**Levels of Panel Agreement with Recommendation (Strength of Panel
Opinion)**

Low - Mean agreement score 1.0 to less than 2.33

Moderate - Mean agreement score 2.33 to less than 3.67

Strong - Mean agreement score 3.67 to 5.0

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is specifically
stated for each recommendation (see \"Major Recommendations\" field).

A list of references is provided in the original guideline document,
which includes all sources used by the guideline development panel to
support their recommendations. It provides the level of scientific
evidence (I-V) for each graded article.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   The goal of bladder management in adults with spinal cord injury is
    to maintain and preserve a functional, infection-free genitourinary
    system by preventing upper and lower tract complications with a
    management system that is compatible with an injury-free lifestyle.

-   The ultimate goal of therapy is to achieve and maintain adequate
    bladder drainage with low-pressure urine storage and voiding.

#### POTENTIAL HARMS

Potential complications with intermittent catheterization are:

-   Urinary tract infections

-   Bladder overdistention

-   Urinary incontinence

-   Urethral trauma with hematuria

-   Urethral false passages

-   Urethral stricture

-   Autonomic dysreflexia (in those with injuries at T6 and above)

-   Bladder stones

Potential complications with Credé and Valsalva are:

-   Incomplete bladder emptying

-   High intravesical pressure

-   Developing and/or worsening vesicoureteral reflux

-   Developing and/or worsening hydronephrosis

-   Abdominal bruising

-   Possible hernia, pelvic organ prolapse, or hemorrhoids

Long-term complications associated with indwelling catheterization
include:

-   Bladder stones

-   Kidney stones

-   Urethral erosions

-   Epididymitis

-   Recurrent symptomatic urinary tract infections

-   Incontinence

-   Pyelonephritis

-   Hydronephrosis from bladder wall thickening or fibrosis

-   Bladder cancer

Potential complications with reflex voiding are:

-   Condom catheter leakage and/or failure

-   Penile skin breakdown from external condom catheter

-   Urethral fistula

-   Symptomatic urinary tract infection (UTI)

-   Poor bladder emptying

-   High intravesical voiding pressures

-   Autonomic dysreflexia in those with injuries at T6 and above

Potential complications of alpha-blockers include orthostatic
hypotension.

Potential complications of botulinum toxin injections into the sphincter
are:

-   Autonomic dysreflexia during the injection (T6 and above)

-   Hematuria during the injection

Potential complications of endourethral stents are:

-   Stone encrustation

-   Stent migration

-   Persistence of autonomic dysreflexia

-   Possible need for removal or replacement

-   Difficulty with removal

-   Possible urethral stricture after removal of stent

-   Urethral trauma

-   Tissue growth into the stent blocking urine flow

-   Urethral pain

Potential complications of a sphincterotomy are:

-   Significant intraoperative and perioperative bleeding

-   Clot retention

-   Prolonged drainage with a large diameter catheter

-   Urethral stricture

-   Erectile dysfunction

-   Ejaculatory dysfunction

-   Reoperation in 30 to 60 percent of cases

Potential complications of posterior sacral rhizotomy are:

-   Loss of reflex erection and reflex ejaculation

-   Loss of sacral sensation

-   Reduction of reflex defecation

-   Transient nerve damage (rarely long term)

Potential complications of electrical stimulation are:

-   Contamination of the device

-   Malfunction of the device

-   Transient nerve damage (rarely long term)

Potential perioperative complications of reconstructive surgery using
intestinal segments include:

-   Anesthetic complications

-   Postoperative ileus and small bowel obstruction

-   Wound separations and infections

-   Mucus production causing blockage

-   Bowel disturbances

-   Persistent urine leakage

-   Bladder perforation

-   Development of bladder stones

-   Vitamin B12 deficiencies

-   Potential or late development of bladder cancer

Potential complications of urinary diversion are:

-   Early complications associated with any major intestinal surgery,
    including anesthetic complications

-   Prolonged ileus (more common in spinal cord injury \[SCI\])

-   Intestinal or urinary leak

-   Sepsis and wound infection

-   Ureteroileal stricture

-   Stomal stenosis

-   Parastomal hernia

-   Intestinal obstruction due to adhesions

-   Urinary infection and stone disease

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

This guideline has been prepared based on the scientific and
professional information available in 2006. Users of this guideline
should periodically review this material to ensure that the advice
herein is consistent with current reasonable clinical practice.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

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

#### IOM CARE NEED

Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Consortium for Spinal Cord Medicine. Bladder management for adults with
spinal cord injury: a clinical practice guideline for health care
providers. Washington (DC): Paralyzed Veterans of America; 2006 Aug. 50
p. \[108 references\]

#### ADAPTATION

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

#### DATE RELEASED

2006 Aug

#### GUIDELINE DEVELOPER(S)

Consortium for Spinal Cord Medicine - Private Nonprofit Organization

#### GUIDELINE DEVELOPER COMMENT

Consortium Member Organizations include: American Academy of Orthopedic
Surgeons, American Academy of Physical Medicine and Rehabilitation,
American Association of Neurological Surgeons, American Association of
Spinal Cord Injury Nurses, American Association of Spinal Cord Injury
Psychologists and Social Workers, American College of Emergency
Physicians, American Congress of Rehabilitation Medicine, American
Occupational Therapy Association, American Paraplegia Society, American
Physical Therapy Association, American Psychological Association,
American Spinal Injury Association, Association of Academic
Physiatrists, Association of Rehabilitation Nurses, Christopher Reeve
Paralysis Foundation, Congress of Neurological Surgeons, Insurance
Rehabilitation Study Group, International Spinal Cord Society, Paralyzed
Veterans of America, United Spinal Association, U.S. Department of
Veterans Affairs

#### SOURCE(S) OF FUNDING

Consortium for Spinal Cord Medicine

#### GUIDELINE COMMITTEE

Guideline Development Panel

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members:* Todd A. Linsenmeyer, MD, Panel Chair (Urology) Kessler
Institute for Rehabilitation, West Orange, NJ (Urology and Physical
Medicine and Rehabilitation) UMDNI --- New Jersey Medical School,
Newark, NJ; Donald R. Bodner, MD (Urology) Louis Stokes VA Medical
Center and University Hospitals Cleveland, Cleveland, OH; Graham H.
Creasey, MD (Spinal Cord Injury Medicine) Louis Stokes VA Medical Center
and MetroHealth Medical Center, Cleveland, OH; Bruce G. Green, MD
(Urology) Sandy Springs Urology Group, Atlanta, GA; Suzanne L. Groah,
MD, MSPH (Physical Medicine & Rehabilitation) National Rehabilitation
Hospital, Washington, DC; Angela Joseph, RN, MSN (SCI Nursing) VA San
Diego Healthcare System, San Diego, CA; L. Keith Lloyd, MD (Urology)
University of Alabama at Birmingham, Birmingham, AL; Inder Perkash, MD
(Urology) VA Palo Alto Health Care System and Stanford University, Palo
Alto, CA; John S. Wheeler, MD (Urology) Edward Hines, Jr., Hospital,
Hines, IL, Loyola University Medical Center, Maywood, IL

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[Paralyzed Veterans of America (PVA) Web
site](http://www.pva.org/site/DocServer/Bladder.WEB.pdf?docID=1101).

Print copies: Available from the Consortium for Spinal Cord Medicine,
Clinical Practice Guidelines, 801 18th Street, NW, Washington, DC 20006.

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on October 2, 2007.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. This summary was
copied and abstracted with permission from the Paralyzed Veterans of
America (PVA).

### DISCLAIMER

#### NGC DISCLAIMER

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Date Modified: 11/3/2008