Neurogenic Lower Urinary Tract Dysfunction: AUA/SUFU Guideline (2021)

To cite this guideline:

  • Ginsberg DA, Boone TB, Cameron AP et al: The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Diagnosis and Evaluation. J Urol 2021; 206: 1097.
  • Ginsberg DA, Boone TB, Cameron AP et al: The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Treatment and Follow-up. J Urol 2021; 206: 1106.

Unabridged version of this guideline [pdf]
Algorithm associated with this guideline [pdf]
Español translated guideline courtesy of Confederacion Americana de Urologia (CAU) [pdf]

Panel Members

David A. Ginsberg, MD; Timothy B. Boone, MD; Anne P. Cameron, MD; Angelo Gousse, MD; Melissa R. Kaufman, MD; Erick Keays; Michael J. Kennelly, MD; Gary E. Lemack, MD; Eric S. Rovner, MD; Lesley H. Souter, PhD; Claire Yang, MD; Stephen R. Kraus, MD

Executive Summary

Purpose

The term neurogenic lower urinary tract dysfunction (NLUTD) refers to abnormal function of either the bladder, bladder neck, and/or its sphincters related to a neurologic disorder. Prior terminology commonly used “neurogenic bladder” to describe this condition. With the understanding that this is not just an issue confined to the bladder, NLUTD is now the preferred way to describe the various voiding issues seen in patient with a neurologic disorder. The clinician treating patients with NLUTD needs to balance a variety of factors when making treatment decisions. In addition to the patient’s urologic symptoms and urodynamic findings (if applicable), other issues that may influence management options of the lower urinary tract include cognition (which can be impacted by the neurologic disorder), hand function, type of neurologic disease (progressive versus stable), mobility, bowel function/management, and social and caregiver support (if needed). This Guideline allows the clinician to understand the options available to treat patients, understand the findings that can be seen in NLUTD, and appreciate which options are best for each individual patient. This allows for decisions to be made with the patient, in a shared-decision making manner, such that the patient’s quality of life can be optimized in regards to their bladder management.

Guideline Statements

Initial Evaluation of the Patient with NLUTD

  1. At initial evaluation, clinicians should identify patients as either:
    a. low-risk, or
    b. unknown-risk, who will require further evaluation to allow for complete risk stratification.
    (Clinical Principle)
  2. At initial evaluation, all patients with NLUTD should undergo a detailed history, physical exam, and urinalysis. (Clinical Principle)
  3. At initial evaluation, patients with NLUTD who spontaneously void should undergo post-void residual measurement. (Clinical Principle)
  4. At initial evaluation, optional studies in patients with NLUTD include a voiding/catheterization diary, pad test, and non-invasive uroflow. (Expert Opinion)
  5. At initial evaluation, in patients with low-risk NLUTD, the clinician should not routinely obtain upper tract imaging, renal function assessment, or multichannel urodynamics. (Moderate Recommendation; Evidence Level: Grade C)
  6. At initial evaluation, in patients with unknown-risk NLUTD, the clinician should obtain upper tract imaging, renal function assessment, and multichannel urodynamics. (Moderate Recommendation; Evidence Level: Grade C)
  7. In the patient with an acute neurological event resulting in NLUTD, the clinician should perform risk stratification once the neurological condition has stabilized. (Clinical Principle)
  8. Clinicians should not perform routine cystoscopy in the initial evaluation of the NLUTD patient. (Clinical Principle)

Autonomic Dysreflexia

  1. During urodynamic testing and/or cystoscopic procedures, clinicians must hemodynamically monitor NLUTD patients at risk for autonomic dysreflexia. (Clinical Principle)
  2. For the NLUTD patient who develops autonomic dysreflexia during urodynamic testing and/or cystoscopic procedures, clinicians must terminate the study, immediately drain the bladder, and continue hemodynamic monitoring. (Clinical Principle)
  3. For the NLUTD patient with ongoing autonomic dysreflexia following bladder drainage, clinicians should initiate pharmacologic management and/or escalate care. (Clinical Principle)

Surveillance of the patient with NLUTD

  1. The clinician must educate patients with NLUTD on the signs and symptoms that would warrant additional assessment. (Clinical Principle)
  2. In patients with low-risk NLUTD and stable urinary signs and symptoms, the clinician should not obtain surveillance upper tract imaging, renal function assessment, or multichannel urodynamics. (Moderate Recommendation; Evidence Level: Grade C)
  3. In patients with moderate-risk NLUTD and stable urinary signs and symptoms, the clinician should assess the patient with:
    a. annual focused history, physical exam, and symptom assessment.
    b. annual renal function assessment.
    c. upper tract imaging every 1-2 years.
    (Moderate Recommendation; Evidence Level: Grade C)
  4. In patients with high-risk NLUTD and stable urinary signs and symptoms, the clinician should assess the patient with:
    a. annual focused history, physical exam, and symptom assessment.
    b. annual renal function assessment.
    c. annual upper tract imaging.
    d. multichannel urodynamic studies, with or without fluoroscopy, which may be repeated when clinically indicated.
    (Moderate Recommendation; Evidence Level: Grade C)
  5. In patients with low-risk NLUTD who present with new onset signs and symptoms, new complications (e.g., autonomic dysreflexia, urinary tract infections, stones), and/or upper tract or renal function deterioration, the clinician should re-evaluate and repeat risk stratification. (Clinical Principle)
  6. In patients with moderate- or high-risk NLUTD who experience a change in signs and symptoms, new complications (e.g., autonomic dysreflexia, urinary tract infections, stones), or upper tract or renal function deterioration, the clinician may perform multichannel urodynamics. (Clinical Principle)
  7. In the NLUTD patient with concomitant hematuria, recurrent urinary tract infections, or suspected anatomic anomaly (e.g., strictures, false passage), clinicians should perform cystoscopy. (Moderate Recommendation; Evidence Level: Grade B)
  8. In NLUTD patients, clinicians should not perform screening/surveillance cystoscopy. (Strong Recommendation; Evidence Level: Grade B)
  9. In NLUTD patients with a chronic indwelling catheter, clinicians should not perform screening/surveillance cystoscopy. (Strong Recommendation; Evidence Level: Grade B)
  10. In NLUTD patients with indwelling catheters, clinicians should perform interval physical examination of the catheter and the catheter site (suprapubic or urethral). (Moderate Recommendation; Evidence Level: Grade C)
  11. In NLUTD patients with indwelling catheters who are at risk for upper and lower urinary tract calculi (e.g., patients with spinal cord injury, recurrent urinary tract infection, immobilization, hypercalcuria) clinicians should perform urinary tract imaging every 1-2 years. (Moderate Recommendation; Evidence Level: Grade C)

Urinary Tract Infections

  1. In asymptomatic NLUTD patients, clinicians should not perform surveillance/screening urine testing, including urine culture. (Moderate Recommendation; Evidence Level: Grade C)
  2. Clinicians should not treat asymptomatic bacteriuria in patients with NLUTD. (Moderate Recommendation; Evidence Level: Grade C)
  3. In NLUTD patients with signs and symptoms suggestive of a urinary tract infection, clinicians should obtain a urinalysis and urine culture. (Moderate Recommendation; Evidence Level: Grade C)
  4. In NLUTD patients with a febrile urinary tract infection, clinicians should order upper tract imaging if:
    a. the patient does not respond appropriately to antibiotic therapy.
    b. the patient is moderate- or high-risk and is not up to date with routine upper tract imaging, regardless of their response to therapy.
    (Clinical Principle)
  5. In NLUTD patients with a suspected urinary tract infection and an indwelling catheter, clinicians should obtain the urine culture specimen after changing the catheter and after allowing for urine accumulation while plugging the catheter. Urine should not be obtained from the extension tubing or collection bag. (Clinical Principle)
  6. In NLUTD patients with recurrent urinary tract infections, clinicians should evaluate the upper and lower urinary tracts with imaging and cystoscopy. (Clinical Principle)
  7. In NLUTD patients with recurrent urinary tract infections and an unremarkable evaluation of the upper and lower urinary tract, clinicians may perform urodynamic evaluation. (Conditional Recommendation; Evidence Level: Grade C)
  8. In NLUTD patients who manage their bladder with an indwelling catheter, clinicians should not use daily antibiotic prophylaxis to prevent urinary tract infection. (Strong Recommendation; Evidence Level: Grade B)
  9. In NLUTD patients who manage their bladders with clean intermittent catheterization and do not have recurrent urinary tract infections, clinicians should not use daily antibiotic prophylaxis. (Moderate Recommendation; Evidence Level: Grade B)

Non-Surgical Treatment

  1. Clinicians may recommend pelvic floor muscle training for appropriately selected patients with NLUTD, particularly those with multiple sclerosis or cerebrovascular accident, to improve urinary symptoms and quality of life measures. (Conditional Recommendation; Evidence Level: Grade C)
  2. Clinicians may recommend antimuscarinics or beta-3 adrenergic receptor agonists, or a combination of both, to improve bladder storage parameters in NLUTD patients. (Conditional Recommendation; Evidence Level: Grade C)
  3. Clinicians may recommend alpha-blockers to improve voiding parameters in NLUTD patients who spontaneously void. (Conditional Recommendation; Evidence Level: Grade C)
  4. Clinicians should recommend intermittent catheterization rather than indwelling catheters to facilitate bladder emptying in patients with NLUTD. (Strong Recommendation; Evidence Level: Grade C)
  5. For appropriately selected NLUTD patients who require a chronic indwelling catheter, clinicians should recommend suprapubic catheterization over an indwelling urethral catheter. (Strong Recommendation; Evidence Level: Grade C)
  6. In NLUTD patients who perform clean intermittent catheterization with recurrent urinary tract infection, clinicians may offer oral antimicrobial prophylaxis to reduce the rate of urinary tract infections following shared decision-making and discussion regarding increased risk of antibiotic resistance. (Conditional Recommendation; Evidence Level: Grade C)
  7. In NLUTD patients who perform clean intermittent catheterization with recurrent urinary tract infection, clinicians may offer bladder instillations to reduce the rate of urinary tract infections. (Expert Opinion)
  8. Clinicians may counsel NLUTD patients with recurrent urinary tract infection who use various forms of catheter management that cranberry extract has not been demonstrated to reduce the rate of urinary tract infections. (Conditional Recommendation; Evidence Level: Grade B)
  9. In NLUTD patients with spinal cord injury or multiple sclerosis refractory to oral medications, clinicians should recommend onabotulinumtoxinA to improve bladder storage parameters, decrease episodes of incontinence, and improve quality of life measures. (Strong Recommendation; Evidence Level: Grade A)
  10. In NLUTD patients, other than those with spinal cord injury and multiple sclerosis, who are refractory to oral medications, clinicians may offer onabotulinumtoxinA to improve bladder storage parameters, decrease episodes of incontinence, and improve quality of life measures. (Conditional Recommendation; Evidence Level: Grade C)
  11. In NLUTD patients who spontaneously void, clinicians must discuss the specific risks of urinary retention and the potential need for intermittent catheterization prior to selecting botulinum toxin therapy. (Clinical Principle)

Surgical Treatment

  1. Clinicians may offer sphincterotomy to facilitate emptying in appropriately selected male patients with NLUTD, but must counsel them of the high-risk of failure or potential need for additional treatment or surgery. (Conditional Recommendation; Evidence Level: Grade C)
  2. Clinicians may offer urethral bulking agents to NLUTD patients with stress urinary incontinence but must counsel them that efficacy is modest and cure is rare. (Conditional Recommendation; Evidence Level: Grade C)
  3. Clinicians should offer slings to select NLUTD patients with stress urinary incontinence and acceptable bladder storage parameters. (Moderate Recommendation; Evidence Level: Grade C)
  4. Clinicians may offer artificial urinary sphincter to select NLUTD patients with stress urinary incontinence and acceptable bladder storage parameters. (Conditional Recommendation; Evidence Level: Grade C)
  5. After a thorough discussion of risks, benefits, and alternatives, clinicians may offer bladder neck closure and concomitant bladder drainage methods to select patients with NLUTD and refractory stress urinary incontinence. (Expert Opinion)
  6. Clinicians may offer posterior tibial nerve stimulation to select spontaneous voiding NLUTD patients with urgency, frequency, and/or urgency incontinence. (Conditional Recommendation; Evidence Level: Grade C)
  7. Clinicians may offer sacral neuromodulation to select NLUTD patients with urgency, frequency, and/or urgency incontinence. (Conditional Recommendation; Evidence Level: Grade C)
  8. Clinicians should not offer sacral neuromodulation to NLUTD patients with spinal cord injury or spina bifida. (Moderate Recommendation; Evidence Level: Grade C)
  9. Clinicians may offer augmentation cystoplasty to select NLUTD patients who are refractory to, or intolerant of, less invasive therapies for detrusor overactivity and/or poor bladder compliance. (Conditional Recommendation; Evidence Level: Grade C)
  10. Clinicians may offer continent cathererizable channels, with or without augmentation, to select NLUTD patients to facilitate catheterization. (Conditional Recommendation; Evidence Level: Grade C)
  11. Clinicians may offer ileovesicostomy to select patients with NLUTD and must counsel them on the risks, benefits, alternatives, and the high-risk of needing additional treatment or surgery. (Conditional Recommendation; Evidence Level: Grade C)
  12. Clinicians should offer urinary diversion to NLUTD patients in whom other options have failed, or are inappropriate, to improve long-term quality of life. (Moderate Recommendation; Evidence Level: Grade C)
  13. Other potential treatments for NLUTD should be considered investigational and patients should be counseled accordingly. (Expert Opinion)

Follow-Up and Post Treatment

  1. In NLUTD patients with impaired storage parameters and/or voiding that place their upper tracts at risk, clinicians should repeat urodynamic studies at an appropriate interval following treatment. (Expert Opinion)
  2. In NLUTD patients with impaired storage parameters that place their upper tracts at risk and are refractory to therapy, clinicians should offer additional treatment. (Expert Opinion)
  3. 58. In NLUTD patients who have undergone lower urinary tract reconstruction incorporating a bowel segment(s), the clinician should assess the patient annually with:
    a. focused history, physical exam, and symptom assessment.
    b. basic metabolic panel.
    c. urinary tract imaging.
    (Expert Opinion)
  4. Clinicians may perform urodynamics following sphincterotomy to assess outcome. (Conditional Recommendation; Evidence Level: Grade C)
  5. In NLUTD patients who have undergone lower urinary tract reconstruction utilizing bowel, and who also develop gross hematuria or symptomatic recurrent urinary tract infection, clinicians should perform cystoscopy. (Moderate Recommendation; Evidence Level: Grade C)

Introduction

The term neurogenic lower urinary tract dysfunction (NLUTD) refers to abnormal function of either the bladder, bladder neck, and/or its sphincters related to a neurologic disorder. Prior terminology commonly used “neurogenic bladder” to describe this condition. With the understanding that this is not just an issue confined to the bladder, NLUTD is now the preferred way to describe the various voiding issues seen in patient with a neurologic disorder. NLUTD is a broad term in several respects. A wide array of potential neurologic etiologies can lead to lower urinary dysfunction. As demonstrated by the Functional Classification System, NLUTD can impact a.) the bladder’s ability to store or empty urine at a socially acceptable time and location; and b.) the sphincter’s ability to relax at the time of voiding as well as maintain continence during bladder filling. For example, some patients can have urinary incontinence (UI) while others may have urinary retention requiring intermittent catherization (CIC). In addition, NLUTD is not necessarily confined to only one of these categories and is often a mixture of several issues; for example, patients could have both UI and urinary retention. NLUTD can also occur concomitantly with urinary symptoms and lower urinary tract symptoms (LUTS) that are not neurogenic in origin. Examples of this would include a man with NLUTD, secondary to Parkinson’s disease (PD) also having obstructive voiding symptoms from an enlarged prostate, or a women with NLUTD secondary to a cerebrovascular accident (CVA) also with symptoms of stress urinary incontinence (SUI). Lastly, NLUTD symptoms can evolve over time. For example, patients with NLUTD secondary to diabetes may initially be asymptomatic, then progress to overactive bladder (OAB)-type symptoms and ultimately evolve to a bladder with incomplete emptying and possible overflow incontinence.1

NLUTD is often categorized by the neuroanatomic location (suprapontine, suprasacral spinal cord, or sacral) of the neurologic deficit contributing to the abnormal lower urinary tract function. Depending on the location of the neurological lesion, common pathophysiological patterns of NLUTD manifest. Diagnoses of the brain and brainstem leading to NLUTD include brain tumors, PD, normal pressure hydrocephalus, CVA, and traumatic brain injury. The most common of these diseases is CVA. In the United States, approximately 795,000 people experience a CVA every year2 with 28-79% having symptoms of UI post-CVA.3-7

The two most common causes of NLUTD from spinal cord lesions are multiple sclerosis (MS) and spinal cord injury (SCI). The estimated prevalence of MS in 2010 in the United States, culminated over ten years, ranged from 288 to 309 per 100,000, which corresponds to a total of 523,437 to 727,344 cases of MS.8 Studies have suggested that up to 50-90% of patients with MS have LUTS9 with up to 65% of respondents to a 2005 North American Research Committee On Multiple Sclerosis survey noting moderate to severe urinary symptoms.10 It should be appreciated that LUTS in the MS population could be secondary to emptying symptoms, storage symptoms, or a combination of both. According to the National Spinal Cord Injury Statistical Center, there are approximately 17,700 new cases of SCI each year and 247,000 to 358,000 persons in the United States are living with SCI as of 2018.11 The majority of patients with a SCI have some degree of NLUTD with over 80% requiring use of a catheter (e.g., condom, intermittent, indwelling) post-injury.12

Common causes of NLUTD at the peripheral nerve level include diabetes and iatrogenic injuries from surgeries such as abdominoperineal resection and radical hysterectomy. It is estimated that 34.2 million Americans, or 10.5% of the total population, had diabetes in 2018,13 with up to 80% of diabetics experiencing some type of lower urinary tract complication during their lifetime.14

NLUTD can have a significant impact on patients’ quality of life (QoL). The degree to which this impacts patients is demonstrated by the fact that, given the choice, SCI patients did not have a preference if choosing between an improvement in the bladder/bowel function versus obtaining the ability to walk.15 Prior to World War II, the primary cause of death for patients with a SCI was renal failure secondary to suboptimal management of their bladder.16 Presently, with better understanding of the importance of bladder storage pressures, renal failure and renal complications are less common causes of death. This speaks to one of the main goals for the clinician caring for patients with NLUTD: understanding risk of upper urinary tract damage and managing the patient in such a way that risk is minimized. However, there are often a variety of other issues that the clinician caring for the patient with NLUTD may need to address. In addition to LUTS, such as UI and retention, patients with NLUTD may experience recurrent urinary tract infection (UTI) and autonomic dysreflexia (AD), which this Guideline will address. Non-urinary conditions such as sexual dysfunction, male infertility, and bowel dysfunction are also common in patients with NLUTD but are not within the scope of this Guideline. It should also be noted that this is a Guideline for adult patients with NLUTD and pediatric NLUTD will not be discussed.

The initial urologic evaluation and subsequent surveillance of the NLUTD patient differs depending on the etiology and severity of the neurologic injury or disease. In addition to the standard history, physical examination, and urinalysis (UA), there are a variety of tools that are used in the evaluation of NLUTD patients. These may include evaluations and tests such as voiding diaries, questionnaires (e.g., NBSS, Qualiveen), measurement of post-void residual (PVR), uroflow, urodynamics (UDS), renal ultrasound (US), and cystoscopy. All NLUTD patients do not need all of these studies. This Guideline will help clinicians caring for patients with NLUTD understand what the appropriate initial evaluation should entail. Once that is done, the patient is then placed into one of the three levels of risk: low; medium; high (Figure 1). The level of risk then determines what would be the appropriate surveillance over time.

The clinician treating patients with NLUTD needs to balance a variety of factors when making treatment decisions. In addition to the patient’s urologic symptoms and urodynamic findings (if applicable), other issues that may influence management options of the lower urinary tract include cognition (which can be impacted by the neurologic disorder), hand function, type of neurologic disease (progressive versus stable), mobility, bowel function/management, and social and caregiver support (if needed). This Guideline allows the clinician to understand the options available to treat patients with various types of LUTS, understand the findings that can be seen in NLUTD, and appreciate which options are best for each individual patient. This would allow for decisions to be made with the patient, in a shared decision-making manner, such that the patient’s quality of life can be optimized in regard to their bladder management.

Panel Formation

The Panel was created in 2016 by the American Urological Association Education and Research, Inc. (AUAER). This guideline was developed in collaboration with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). The Practice Guidelines Committee (PGC) of the AUA selected the Panel Chairs who in turn appointed the additional panel members with specific expertise in this area in conjunction with SUFU. Additionally, the Panel included patient representation. Funding of the Panel was provided by the AUA; panel members received no remuneration for their work.

Methods and Methodology

Literature Search Strategy

A comprehensive search for relevant systematic reviews assessing patients undergoing evaluation, surveillance, management, or follow-up for NLUTD was conducted using MEDLINE, Embase, and the Cochrane Library for systematic reviews databases in October 2017. The search was rerun in February 2021 to identify systematic reviews published from October 2017 through 2021. Where no existing systematic reviews were identified, or when identified reviews were incomplete in some fashion, PubMed (MEDLINE) and Embase databases were systematically searched using standardized vocabulary and keywords derived using the a priori developed PICO (population, interventions, comparisons, and outcomes) elements. Control articles, which were deemed important and relevant by the Panel, were compared with the literature search strategy output and the strategy was updated as necessary to capture all control articles. Databases were searched for studies published from January 2001 through October 2017 and the search was rerun in February 2021 to capture the newer literature.

Study Selection Criteria and Process

All hits from the literature search were input into reference management software (EndNote X7), where duplicate citations were removed. Abstracts were reviewed by the methodologist to determine if the study addressed the Key Questions and if the study met study design inclusion criteria. For all research questions, randomized controlled trials, observational studies, and case-control studies were considered for inclusion in the evidence base. Although studies of any sample size were included, where data was available, only studies that enrolled at least 30 patients were used to inform recommendation statements. Case series, letters, editorials, in vitro studies, studies conducted in animal models, and studies not published in English were excluded from the evidence base a priori.

Full-text review was conducted on studies that passed the abstract screening phase. Studies that met the PICO criteria were chosen for inclusion in the evidence base. Figure 1 summarizes the study selection process.

Figure 1. Primary Literature Search Flow Diagram

Data Extraction

Data were extracted from all studies that passed full-text review by the methodologist.

Quality Assessment

Individual Study Quality and Potential for Bias
Quality assessment for all retained studies was conducted. Using this method, studies deemed to be of low quality would not be excluded from the systematic review, but would be retained, and their methodological strengths and weaknesses discussed where relevant. To define an overall study quality rating for each included study, risk of bias as determined by validated study-type specific tools, was paired with additional important quality features. To evaluate the risk of bias within the identified studies, the Assessment of Multiple Systematic Reviews (AMSTAR)17 tool was used for systematic reviews, the Cochrane Risk of Bias Tool18 was used for randomized studies, and a Risk of Bias in Non-Randomized Studies – of Intervention (ROBINS-I)19 was used for observational studies. Additional important quality features, such as study design, comparison type, power of statistical analysis, and sources of funding were extracted for each study.

Certainty of Evidence by GRADE
The Grading of Recommendations Assessment, Development, and Evaluation (GRADE)20 system was used to determine the aggregate evidence quality for each outcome, or group of related outcomes, informing each guideline statement. GRADE defines a body of evidence in relation to how confident guideline developers can be that the estimate of effects as reported by that body of evidence is correct. Evidence is categorized as high, moderate, low and very low, and assessment is based on the aggregate risk of bias for the evidence base, plus limitations introduced as a consequence of inconsistency, indirectness, imprecision and publication bias across the studies.21 Upgrading of evidence is possible if the body of evidence indicates a large effect or if confounding would suggest either spurious effects or would reduce the demonstrated effect.

The AUA employs a 3-tiered strength of evidence system to underpin evidence-based guideline statements. Table 1 summarizes the GRADE categories, definitions and how these categories translate to the AUA strength of evidence categories. In short, high certainty by GRADE translates to AUA A-category strength of evidence, moderate to B, and both low and very low to C.

Table 1: Strength of Evidence Definitions
AUA Strength of Evidence CategoryGRADE Certainty RatingDefinition
AHigh
  • We are very confident that the true effect lies close to that of the estimate of the effect
BModerate
  • We are moderately confident in the effect estimate
  • The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
CLow
 
Very Low
  • Our confidence in the effect estimate is limited
  • The true effect may be substantially different from the estimate of the effect
 
  • We have very little confidence in the effect estimate
  • The true effect is likely to be substantially different from the estimate of effect

AUA Nomenclature: Linking Statement Type to Evidence Strength

The AUA nomenclature system explicitly links statement type to body of evidence strength, level of certainty, magnitude of benefit or risk/burdens, and the Panel’s judgment regarding the balance between benefits and risks/burdens (Table 2). Strong Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is substantial. Moderate Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is moderate. Conditional Recommendations are non-directive statements used when the evidence indicates that there is no apparent net benefit or harm, when benefits and harms are finely balanced, or when the balance between benefits and risks/burden is unclear. All three statement types may be supported by any body of evidence strength grade. Body of evidence strength Grade A in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances and that future research is unlikely to change confidence. Body of evidence strength Grade B in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence could change confidence. Body of evidence strength Grade C in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence is likely to change confidence. Conditional Recommendations also can be supported by any evidence strength. When body of evidence strength is Grade A, the statement indicates that benefits and risks/burdens appear balanced, the best action depends on patient circumstances, and future research is unlikely to change confidence. When body of evidence strength Grade B is used, benefits and risks/burdens appear balanced, the best action also depends on individual patient circumstances and better evidence could change confidence. When body of evidence strength Grade C is used, there is uncertainty regarding the balance between benefits and risks/burdens; therefore, alternative strategies may be equally reasonable, and better evidence is likely to change confidence.

Where gaps in the evidence existed, the Panel provides guidance in the form of Clinical Principles or Expert Opinions with consensus achieved using a modified Delphi technique if differences of opinion emerged.38 A Clinical Principle is a statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature. Expert Opinion refers to a statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there may or may not be evidence.

TABLE 2: AUA Nomenclature Linking Statement Type to Level of Certainty, Magnitude of Benefit or Risk/Burden, and Body of Evidence Strength
Evidence GradeEvidence Strength A
(High Certainty)
Evidence Strength B
(Moderate Certainty)
Evidence Strength C
(Low Certainty)
Strong Recommendation
(Net benefit or harm substantial)
Benefits > Risks/Burdens (or vice versa)
Net benefit (or net harm) is substantial
Applies to most patients in most circumstances and future research unlikely to change confidence
Benefits > Risks/Burdens (or vice versa)
Net benefit (or net harm) is substantial
Applies to most patients in most circumstances but better evidence could change confidence
Benefits > Risks/Burdens (or vice versa)
Net benefit (or net harm) appears substantial
Applies to most patients in most circumstances but better evidence is likely to change confidence
(rarely used to support a Strong Recommendation)
Moderate Recommendation
(Net benefit or harm moderate)
Benefits > Risks/Burdens (or vice versa)
Net benefit (or net harm) is moderate
Applies to most patients in most circumstances and future research is unlikely to change confidence
Benefits > Risks/Burdens (or vice versa)
Net benefit (or net harm) is moderate
Applies to most patients in most circumstances but better evidence could change confidence
Benefits > Risks/Burdens (or vice versa)
Net benefit (or net harm) appears moderate
Applies to most patients in most circumstances but better evidence is likely to change confidence
Conditional Recommendation
(No apparent net benefit or harm)
Benefits = Risks/Burdens
Best action depends on individual patient circumstances
Future research unlikely to change confidence
Benefits = Risks/Burdens
Best action appears to depend on individual patient circumstances
Better evidence could change confidence
Balance between Benefits & Risks/Burdens unclear
Alternative strategies may be equally reasonable
Better evidence likely to change confidence

Results

Search for Existing Systematic Reviews
The search for existing systematic reviews identified 45 possible reviews on evaluation, surveillance, management, or follow-up of patients with NLUTD. Twenty-five were chosen for inclusion in the evidence base. When multiple systematic reviews reported on the same outcome and included the same primary literature, only the most complete systematic review was retained. All 20 excluded systematic reviews were excluded based on overlapping primary literature when compared to the systematic reviews chosen for inclusion in the evidence base.

Search for Primary Literature
The primary literature systematic review was used to address all outcomes not covered by the included systematic reviews. It was anticipated that primary literature would report on outcomes in addition to what was pooled in the 24 included systematic reviews. As such, the literature search for primary literature was not altered following selection of the systematic review into the evidence base. Instead, where overlap was recognized between studies included in the identified systematic reviews and identified primary studies, primary studies were either removed from the evidence base, or when primary literature reported on additional outcomes, overlapping outcomes were not extracted in the primary literature. This methodology ensured that data were not included twice in the evidence base, as this may result in an overestimate of effect.

Literature Search Results
The primary search returned 20,496 unique citations. Following a title and abstract screen, full texts were obtained for 3,036 studies. During full-text review, studies were primarily excluded for not meeting the PICO criteria (irrelevant, n=1,443). One hundred eight-four primary literature studies met the inclusion criteria and were included in the evidence base (Figure 1).

Peer Review and Document Approval

An integral part of the guideline development process at the AUA is external peer review. The AUA conducted a thorough peer review process to ensure that the document was reviewed by experts in the diagnosis and management of NLUTD. In addition to reviewers from the AUA PGC, Science and Quality Council, and Board of Directors, the document was reviewed by representatives from SUFU as well as external content experts. Additionally, a call for reviewers was placed on the AUA website from May 26 – June 7, 2021 to allow any additional interested parties to request a copy of the document for review. The guideline was also sent to the Urology Care Foundation to open the document further to the patient perspective. The draft guideline document was distributed to 34 peer reviewers. All peer review comments were blinded and sent to the Panel for review. In total, 23 reviewers provided comments, including 3 external reviewers. At the end of the peer review process, a total of 825 comments were received. Following comment discussion, the Panel revised the draft as needed. Once finalized, the guideline was submitted for approval to the AUA PGC, Science and Quality Council, and Board of Directors, as well as the governing bodies of SUFU for final approval.

Guideline Statements

Initial Evaluation of the Patient with NLUTD

Guideline Statement 1

At initial evaluation, clinicians should identify patients as either:
a. low-risk, or
b. unknown risk, who will require further evaluation to allow for complete risk stratification.
(Clinical Principle)

Discussion


Guideline Statement 2

2. At initial evaluation, all patients with NLUTD should undergo a detailed history, physical exam, and urinalysis. (Clinical Principle)

Discussion


Guideline Statement 3

3. At initial evaluation, patients with NLUTD who spontaneously void should undergo post-void residual measurement. (Clinical Principle)

Discussion


Guideline Statement 4

4. At initial evaluation, optional studies in patients with NLUTD include a voiding/catheterization diary, pad test, and non-invasive uroflow. (Expert Opinion)

Discussion


Guideline Statement 5

5. At initial evaluation, in patients with low-risk NLUTD, the clinician should not routinely obtain upper tract imaging, renal function assessment, or multichannel urodynamics. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 6

6. At initial evaluation, in patients with unknown-risk NLUTD, the clinician should obtain upper tract imaging, renal function assessment, and multichannel urodynamics. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 7

7. In the patient with an acute neurological event resulting in NLUTD, the clinician should perform risk stratification once the neurological condition has stabilized. (Clinical Principle)

Discussion


Guideline Statement 8

8. Clinicians should not perform routine cystoscopy in the initial evaluation of the NLUTD patient. (Clinical Principle)

Discussion


Autonomic Dysreflexia

Guideline Statement 9

9. During urodynamic testing and/or cystoscopic procedures, clinicians must hemodynamically monitor NLUTD patients at risk for autonomic dysreflexia. (Clinical Principle)

Discussion


Guideline Statement 10

10. For the NLUTD patient who develops autonomic dysreflexia during urodynamic testing and/or cystoscopic procedures, clinicians must terminate the study, immediately drain the bladder, and continue hemodynamic monitoring. (Clinical Principle)

Discussion


Guideline Statement 11

11. For the NLUTD patient with ongoing autonomic dysreflexia following bladder drainage, clinicians should initiate pharmacologic management and/or escalate care. (Clinical Principle)

Discussion


Surveillance of the Patient with NLUTD

Guideline Statement 12

12. The clinician must educate patients with NLUTD on the signs and symptoms that would warrant additional assessment. (Clinical Principle)

Discussion


Guideline Statement 13

13. In patients with low-risk NLUTD and stable urinary signs and symptoms, the clinician should not obtain surveillance upper tract imaging, renal function assessment, or multichannel urodynamics. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 14

14. In patients with moderate-risk NLUTD and stable urinary signs and symptoms, the clinician should assess the patient with:

  1. annual focused history, physical exam, and symptom assessment.
  2. annual renal function assessment.
  3. upper tract imaging every 1-2 years.

 

(Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 15

15. In patients with high-risk NLUTD and stable urinary signs and symptoms, the clinician should assess the patient with:

  1. annual focused history, physical exam, and symptom assessment.
  2. annual renal function assessment.
  3. annual upper tract imaging.
  4. multichannel urodynamic studies, with or without fluoroscopy, which may be repeated when clinically indicated.

 

(Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 16

16. In patients with low-risk NLUTD who present with new onset signs and symptoms, new complications (e.g., autonomic dysreflexia, urinary tract infections, stones), and/or upper tract or renal function deterioration, the clinician should re-evaluate and repeat risk stratification. (Clinical Principle)

Discussion


Guideline Statement 17

17. In patients with the moderate- or high-risk NLUTD who experience a change in signs and symptoms, new complications (e.g., autonomic dysreflexia, urinary tract infections, stones), or upper tract or renal function deterioration, the clinician may perform multichannel urodynamics. (Clinical Principle)

Discussion


Guideline Statement 18

18. In the NLUTD patient with concomitant hematuria, recurrent urinary tract infections, or suspected anatomic anomaly (e.g., strictures, false passage), clinicians should perform cystoscopy. (Moderate Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 19

19. In NLUTD patients, clinicians should not perform screening/surveillance cystoscopy. (Strong Recommendation; Evidence Level: Grade B)

Guideline Statement 20

20. In NLUTD patients with a chronic indwelling catheter, clinicians should not perform screening/surveillance cystoscopy. (Strong Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 21

21. In NLUTD patients with indwelling catheters, clinicians should perform interval physical examination of the catheter and the catheter site (suprapubic or urethral). (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 22

22. In NLUTD patients with indwelling catheters who are at risk for upper and lower urinary tract calculi (e.g., patients with spinal cord injury, recurrent urinary tract infection, immobilization, hypercalcuria), clinicians should perform urinary tract imaging every 1-2 years. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Urinary Tract Infections

Guideline Statement 23

23. In asymptomatic NLUTD patients, clinicians should not perform surveillance/screening urine testing, including urine culture. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 24

24. Clinicians should not treat asymptomatic bacteriuria in patients with NLUTD. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 25

25. In NLUTD patients with signs and symptoms suggestive of a urinary tract infection, clinicians should obtain a urinalysis and urine culture. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 26

26. In NLUTD patients with a febrile urinary tract infection, clinicians should order upper tract imaging if:

  1. the patient does not respond appropriately to antibiotic therapy.
  2. the patient is moderate- or high-risk and is not up to date with routine upper tract imaging, regardless of their response to therapy.

 

(Clinical Principle)

Discussion


Guideline Statement 27

27. In NLUTD patients with a suspected urinary tract infection and an indwelling catheter, clinicians should obtain the urine culture specimen after changing the catheter and after allowing for urine accumulation while plugging the catheter. Urine should not be obtained from the extension tubing or collection bag. (Clinical Principle)

Discussion


Guideline Statement 28

28. In NLUTD patients with recurrent urinary tract infections, clinicians should evaluate the upper and lower urinary tracts with imaging and cystoscopy. (Clinical Principle)

Discussion


Guideline Statement 29

29. In NLUTD patients with recurrent urinary tract infections and an unremarkable evaluation of the upper and lower urinary tract, clinicians may perform urodynamic evaluation. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 30

30. In NLUTD patients who manage their bladder with an indwelling catheter, clinicians should not use daily antibiotic prophylaxis to prevent urinary tract infection. (Strong Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 31

31. In NLUTD patients who manage their bladders with clean intermittent catheterization and do not have recurrent urinary tract infections, clinicians should not use daily antibiotic prophylaxis. (Moderate Recommendation; Evidence Level: Grade B)

Discussion


Non-Surgical Treatment

Guideline Statement 32

32. Clinicians may recommend pelvic floor muscle training for appropriately selected patients with NLUTD, particularly those with multiple sclerosis or cerebrovascular accident, to improve urinary symptoms and quality of life measures. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 33

33. Clinicians may recommend antimuscarinics, or beta-3 adrenergic receptor agonists, or a combination of both, to improve bladder storage parameters in NLUTD patients. (Conditional Recommendation; Evidence Level: Grade C)

Guideline Statement 34

34. Clinicians may recommend alpha-blockers to improve voiding parameters in NLUTD patients who spontaneously void. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 35

35. Clinicians should recommend intermittent catheterization rather than indwelling catheters to facilitate bladder emptying in patients with NLUTD. (Strong Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 36

36. For appropriately selected NLUTD patients who require a chronic indwelling catheter, clinicians should recommend suprapubic catheterization over an indwelling urethral catheter. (Strong Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 37

37. In NLUTD patients who perform clean intermittent catheterization with recurrent urinary tract infection, clinicians may offer oral antimicrobial prophylaxis to reduce the rate of urinary tract infections following shared decision-making and discussion regarding increased risk of antibiotic resistance. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 38

38. In NLUTD patients who perform clean intermittent catheterization with recurrent urinary tract infection, clinicians may offer bladder instillations to reduce the rate of urinary tract infections. (Expert Opinion)

Discussion


Guideline Statement 39

39. Clinicians may counsel NLUTD patients with recurrent urinary tract infection who use various forms of catheter management that cranberry extract has not been demonstrated to reduce the rate of urinary tract infections. (Conditional Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 40

40. In NLUTD patients with spinal cord injury or multiple sclerosis refractory to oral medications, clinicians should recommend onabotulinumtoxinA to improve bladder storage parameters, decrease episodes of incontinence, and improve quality of life measures. (Strong Recommendation; Evidence Level: Grade A)

Discussion


Guideline Statement 41

41. In NLUTD patients, other than those with spinal cord injury and multiple sclerosis, who are refractory to oral medications, clinicians may offer onabotulinumtoxinA to improve bladder storage parameters, decrease episodes of incontinence, and improve quality of life measures. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 42

42. In NLUTD patients who spontaneously void, clinicians must discuss the specific risks of urinary retention and the potential need for intermittent catheterization prior to selecting botulinum toxin therapy. (Clinical Principle)

Discussion


Surgical Treatment

Guideline Statement 43

43. Clinicians may offer sphincterotomy to facilitate emptying in appropriately selected male patients with NLUTD, but must counsel them of the high-risk of failure or potential need for additional treatment or surgery. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 44

44. Clinicians may offer urethral bulking agents to NLUTD patients with stress urinary incontinence but must counsel them that efficacy is modest and cure is rare. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 45

45. Clinicians should offer slings to select NLUTD patients with stress urinary incontinence and acceptable bladder storage parameters. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 46

46. Clinicians may offer artificial urinary sphincter to select NLUTD patients with stress urinary incontinence and acceptable bladder storage parameters. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 47

47. After a thorough discussion of risks, benefits, and alternatives, clinicians may offer bladder neck closure and concomitant bladder drainage methods to select patients with NLUTD and refractory stress urinary incontinence. (Expert Opinion)

Discussion


Guideline Statement 48

48. Clinicians may offer posterior tibial nerve stimulation to select spontaneous voiding NLUTD patients with urgency, frequency, and/or urgency incontinence. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 49

49. Clinicians may offer sacral neuromodulation to select NLUTD patients with urgency, frequency, and/or urgency incontinence. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 50

50. Clinicians should not offer sacral neuromodulation to NLUTD patients with spinal cord injury or spina bifida. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 51

51. Clinicians may offer augmentation cystoplasty to select NLUTD patients who are refractory to, or intolerant of, less invasive therapies for detrusor overactivity and/or poor bladder compliance. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 52

52. Clinicians may offer continent catheterizable channels, with or without augmentation, to select NLUTD patients to facilitate catheterization. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 53

53. Clinicians may offer ileovesicostomy to select patients with NLUTD and must counsel them on the risks, benefits, alternatives, and the high-risk of needing additional treatment or surgery. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 54

54. Clinicians should offer urinary diversion to NLUTD patients in whom other options have failed, or are inappropriate, in order to improve long-term quality of life. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 55

55. Other potential treatments for NLUTD should be considered investigational and patients should be counseled accordingly. (Expert Opinion)

Discussion


Follow-Up and Post Treatment

Guideline Statement 56

56. In NLUTD patients with impaired storage parameters and/or voiding that place their upper tracts at risk, clinicians should repeat urodynamic studies at an appropriate interval following treatment. (Expert Opinion)

Discussion


Guideline Statement 57

57. In NLUTD patients with impaired storage parameters that place their upper tracts at risk and are refractory to therapy, clinicians should offer additional treatment. (Expert Opinion)

Discussion


Guideline Statement 58

58. In NLUTD patients who have undergone lower urinary tract reconstruction incorporating a bowel segment(s), the clinician should assess the patient annually with:

  1. focused history, physical exam, and symptom assessment.
  2. basic metabolic panel.
  3. urinary tract imaging.

 

(Expert Opinion)

Discussion


Guideline Statement 59

59. Clinicians may perform urodynamics following sphincterotomy to assess outcome. (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 60

60. In NLUTD patients who have undergone lower urinary tract reconstruction utilizing bowel, and who also develop gross hematuria or symptomatic recurrent urinary tract infection, clinicians should perform cystoscopy. (Moderate Recommendation; Evidence Level: Grade C)

Discussion


Future Directions

Assessment of Bladder Dysfunction: Condition-Specific Questionnaires

Numerous lower urinary tract questionnaires exist for men and women with a variety of conditions. While there certainly is overlap in the urinary symptoms experienced by patients with and without underlying neurological conditions, it is clear that the severity of urinary symptoms may differ considerably.359 For this reason, and because it is also clear that sensation may differ considerably in patients with neurological conditions from those patients that are neurologically intact, it is desirable to assess symptoms in a consistent manner in patients with NLUTD. When possible, the panel advocates use of condition-specific lower urinary tract questionnaires and recommends development and refinement of additional questionnaires to better assess urinary tract dysfunction in patients with NLUTD.360

Improving Current Strategies/Implementing current strategies for new indications

The use of botulinum toxin in patients with neurogenic detrusor overactivity represents a tremendous advancement in the care of many patients with NLUTD. Quality of life has been substantially improved in many patients who otherwise might have been subjected to invasive, morbid and irreversible procedures. While these invasive procedures remain effective and are at times still necessary, they are often associated with both operative risk and postoperative complications. However, the need for repeat injections, the discomfort experienced by some, and the expense pose obstacles for some patients and providers to obtain treatment with intravesical injection of botulinum toxin on a regular basis. The Panel supports the ongoing investigation of alternate injection strategies, as well as the development of different delivery techniques for botulinum toxin so that this agent can be offered more widely.361

Neuromodulation strategies have similarly been extremely effective at ameliorating LUTS/OAB in patients ineffectively treated by other interventions. The use of either peripheral or central neuromodulation in patients with NLUTD has not been widely studied, though small, typically single center cohort observational trials have offered some hope for efficacy in certain NLUTD populations. Further study may allow for a better understanding of which type of stimulation may be more beneficial for specific patient types with NLUTD. With the expected influx of several implantable tibial nerve stimulation devices, it would be reasonable to expect this technology to be evaluated in patients with NLUTD. In addition, it remains possible that various forms of neuromodulation, both invasive and non-invasive, may show promise after SCI.362 This includes therapy as an option to treat symptoms363, 364 or, with early intervention338, 365 as a disease modifying strategy to possibly minimize the progression and severity of NLUTD symptoms over time that can be seen after SCI. The Panel recommends further studies of these techniques, particularly as the latest technology for sacral neuromodulation is MRI-conditional and allows for full body imaging using conventionally available magnets. Other routes of stimulation, such as SARSand the Xiao procedure, remain options as well.342, 366 However, they each have potential issues impacting widespread acceptance. As discussed in Statement 52, there are technical challenges with SARS as well as the risk of loss of certain functions (with concomitant sacral rhizotomy) and the outcomes with Xiao procedure have not been found to be consistently positive. With further study and technology, the Panel is hopeful that these procedures could be more viable treatment options for patients with NLUTD.

Finally, the concept of implanted urethral catheters with valves to promote “natural voiding” (and eliminate or minimize the need for CIC) continues to be studied. There is presently a device that has an FDA indication to treat detrusor underactivity in women using an intraurethral valve pump.367 This device does not have a specific indication for NLUTD. There is also a device being evaluated in male patients with chronic urinary retention.368 The Panel is hopeful that with further research and advancement of technology, devices that would allow for improved bladder emptying for both men and women with NLUTD (and which also minimizes possible issues such as device migration, infection, encrustation, discomfort and pump clogging) will be a treatment option in the future.

Novel Strategies for Urinary Diversion and Augmentation

Various forms of intestinal urinary diversion are not uncommonly required for patients with NLUTD (as well as for patients requiring bladder removal for malignant neoplasms). While bowel is nearly always readily available and quite versatile, its use can be associated with significant metabolic and enteric complications. Prior attempts at bladder replacement have focused on synthetic or bioengineered material; however, to this date none have been particularly successful. A variety of naturally derived, synthetic and bioengineered scaffolds have been developed over the years with the goal being the construction and promotion of an optimal environment for natural cellular ingrowth. While initial clinical reports for utilizing scaffolds were favorable, more recent clinical updates indicate that utilizing autologous smooth muscle cells and urothelial cells seeded onto a biodegradable composite scaffold at the time of bladder augmentation did not lead to improvement in bladder storage pressures and was associated with significant postoperative morbidity.369 Clearly, further investigation of this potential alternative to bowel for patients requiring lower urinary tract reconstruction is desired.

Recent reports have noted the feasibility of bladder allograft transplantation with vascular anastomoses, at least in cadaveric models.370 This represents an exciting possibility and we await further assessment of such a concept to determine if this technically challenging procedure can result in a functional and safe lower urinary tract and, if so, whether it represents a viable option for patients with NLUTD.

Overall, the Panel encourages exploration of novel approaches to surgical urinary diversion and reconstruction including the exploration of non-intestinal concepts, and further development and refinement of tissue-engineered scaffolds to promote endogenous bladder restoration.371

Treatment of the Neurologic Condition

Treatment of the neurologic condition leading to NLUTD is an attractive option – not only could this improve or minimize the bothersome symptoms related to NLUTD but it theoretically could also impact the other, non-urinary symptoms seen in these patients as well. One potential option would be the use of stem cells which has largely been evaluated in patients with acute SCI. Preclinical data has been promising and a review of clinical trials identified ten studies (5 completed, 5 ongoing) that evaluated outcomes in human subjects. Initial data appear to show increased MCC, improved bladder compliance and decreased detrusor pressures; however, urinary incontinence was not improved nor was the need for CIC eliminated.372

Further, high-quality studies are needed to understand if this will be a viable option for future patients with NLUTD secondary to SCI. Additional consideration in regard to stem cell therapy include the treatment of underactive bladder and SUI. Human trials have evaluated the use of stem cells to treat SUI; however, there are still questions to be answered (efficacy, optimal stem cell type, stem cell dose, location of implantation, etc.) before this is a viable therapy.373 In addition, if this does become a viable therapy it is not clear if this therapy would be applicable to NLUTD patients that require CIC. High quality trials evaluating the use of stem cells for underactive bladder have yet to be completed and this has not been specifically evaluated in the NLUTD patient population; however, this is another potential therapy that could improve bladder emptying in those with underactive bladder that require CIC or an indwelling catheter.374

An example of one therapy presently used is deep brain stimulation which is used to treat motor symptoms in patients with PD and other neurological disorders. A systematic review of the effects of DBS on lower urinary tract function found that stimulation of the subthalamic nucleus led to a significant increase in maximum bladder capacity. Other urodynamic parameter changes were not clinically relevant and the authors concluded that deep brain stimulation may have a beneficial effects on lower urinary tract function.375 An additional therapy to potentially treat PD is stem cells. While this is a potentially promising concept, it is unclear if this would be a realistic therapy and trials would clearly be required to evaluate this option.376

The Panel is hopeful that improving therapies to treat the various neurologic conditions that often result in NLUTD will also lead to either an improvement or resolution in the various urinary symptoms associated with that condition.

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Abbreviations

ADAutomatic dysreflexia
AEAdverse events
AUAERAmerican Urological Association
BNBladder neck
BNCBladder neck closure
BOOBladder outlet obstruction
BPHBenign prostatic hyperplasia
CAUTICatheter-associated urinary tract infection
CCCContinent catheterizable channel
CICClean intermittent catheterization
CVACerebrovascular accident
DLPPDetrusor leak point pressures
DODetrusor overactivity
DUDetrusor underactivity
EMGElectromyographic
GUGenitourinary
HTLV-1Human T-Lymphotropic Virus 1
IDSAThe Infectious Disease Society of America
IIQIncontinence impact questionnaire
KUBKidney, ureter, and bladder X-ray
LUTSLower urinary tract symptoms
MCCMaximum cystometric capacity
MDPMaximum detrusor pressure
MSMultiple sclerosis
MUPMaximum urethral pressure
NDONeurogenic detrusor overactivity
NLUTDNeurogenic lower urinary tract dysfunction
OABOveratice bladder
PDParkinson's Disease
PGGPractice Guidelines Committee
PICOPopulations, Interventions, Comparisons, Outcomes
PTNSPosterior tibial nerve stimulation
PVRPost void residual
QoLQuality of life
SBSpina bifida
SCISpinal cord injury
SNMSacral nerve modulation therapy
SPCSuprapubic catheterization
SUFUSociety of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
SUIStress urinary incontinence
SVPSystematic voiding program
UAUrinalysis
UDSUrodynamics
USUltrasound
UIUrinary incontinence
UUIUrgency incontinence
UTIUrinary tract infection
VURVesicoureteral reflux