American Urological Association - Adult Urodynamics: AUA/SUFU Guideline

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Adult Urodynamics: AUA/SUFU Guideline

Published 2012

Unabridged version of this Guideline [pdf]

Panel Members

J. Christian Winters, Roger R. Dmochowski, Howard B. Goldman, C.D. Anthony Herndon, Kathleen C. Kobashi, Stephen R. Kraus, Gary E. Lemack, Victor W. Nitti, Eric S. Rovner, Alan J. Wein

Executive Summary

Purpose

This guideline is intended to review the literature regarding the use of urodynamic testing in common lower urinary tract symptoms (LUTS) conditions. It presents the principles of application and technique to guide the clinician in the role of urodynamics in complex LUTS disorders.  As urodynamics is only one part of the comprehensive evaluation of LUTS, the findings of this guideline are intended to assist the clinician in the appropriate selection of urodynamic tests following an appropriate evaluation and symptom characterization.

Methods

A systematic review of the literature using the MEDLINE® and EMBASE databases (search dates January 1, 1990 to March 10, 2011) was conducted to identify peer-reviewed publications relevant to the use of urodynamic tests for diagnosis, prognosis, guidance of clinical management decisions and improvement of patient outcomes in patients with various urologic conditions. The review yielded an evidence base of 393 studies after application of inclusion/exclusion criteria. These publications were used to inform the statements presented in the guideline as Standards, Recommendations or Options. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate) or C (low). In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinion.

Guideline Statements

Stress Urinary Incontinence (SUI)/Prolapse

1. Clinicians who are making the diagnosis of urodynamic stress incontinence should assess urethral function. (Recommendation; Evidence Strength: Grade C)

2. Surgeons considering invasive therapy in patients with SUI should assess post-void residual (PVR) urine volume. (Expert Opinion)

3. Clinicians may perform multi-channel urodynamics in patients with both symptoms and physical findings of stress incontinence who are considering invasive, potentially morbid or irreversible treatments.  (Option; Evidence Strength: Grade C)

4. Clinicians should perform repeat stress testing with the urethral catheter removed in patients suspected of having SUI who do not demonstrate this finding with the catheter in place during urodynamic testing.  (Recommendation; Evidence Strength: Grade C)

5. Clinicians should perform stress testing with reduction of the prolapse in women with high grade pelvic organ prolapse (POP) but without the symptom of SUI. Multi-channel urodynamics with prolapse reduction may be used to assess for occult stress incontinence and detrusor dysfunction in these women with associated LUTS.  (Option; Evidence Strength: Grade C)

Overactive Bladder (OAB), Urgency Urinary Incontinence (UUI), Mixed Incontinence

6. Clinicians may perform multi-channel filling cystometry when it is important to determine if altered compliance, detrusor overactivity or other urodynamic abnormalities are present (or not) in patients with urgency incontinence in whom invasive, potentially morbid or irreversible treatments are considered.  (Option; Evidence Strength: Grade C)

7. Clinicians may perform pressure flow studies (PFS) in patients with urgency incontinence after bladder outlet procedures to evaluate for bladder outlet obstruction. (Expert Opinion)

8. Clinicians should counsel patients with urgency incontinence and mixed incontinence that the absence of detrusor overactivity (DO) on a single urodynamic study does not exclude it as a causative agent for their symptoms. (Clinical Principle)

Neurogenic Bladder (NGB)

9. Clinicians should perform PVR assessment, either as part of a complete urodynamic study or separately, during the initial urological evaluation of patients with relevant neurological conditions (e.g., spinal cord injury and myelomeningocele) and as part of ongoing follow-up when appropriate.  (Standard; Evidence Strength: Grade B)

10. Clinicians should perform a complex cystometrogram (CMG) during initial urological evaluation of patients with relevant neurological conditions with or without symptoms and as part of ongoing follow-up when appropriate. In patients with other neurological diseases, physicians may consider CMG as an option in the urological evaluation of patients with LUTS. (Recommendation; Evidence Strength: Grade C)

11. Clinicians should perform pressure flow analysis during the initial urological evaluation of patients with relevant neurological conditions with or without symptoms and as part of ongoing follow-up when appropriate, in patients with other neurologic disease and elevated PVR or in patients with persistent symptoms.  (Recommendation, Evidence Strength: Grade C) 

12. When available, clinicians may perform fluoroscopy at the time of urodynamics (videourodynamics) in patients with relevant neurologic disease at risk for neurogenic bladder, in patients with other neurologic disease and elevated PVR or in patients with urinary symptoms. (Recommendation; Evidence Strength: Grade C)

13. Clinicians should perform electromyography (EMG) in combination with CMG with or without PFS in patients with relevant neurologic disease at risk for neurogenic bladder, in patients with other neurologic disease and elevated PVR or in patients with urinary symptoms. (Recommendation; Evidence Strength: Grade C)

LUTS

14. Clinicians may perform PVR in patients with LUTS as a safety measure to rule out significant urinary retention both initially and during follow up. (Clinical Principle)

15. Uroflow may be used by clinicians in the initial and ongoing evaluation of male patients with LUTS when an abnormality of voiding/emptying is suggested. (Recommendation; Evidence Strength: Grade C)

16. Clinicians may perform multi-channel filling cystometry when it is important to determine if DO or other abnormalities of bladder filling/urine storage are present in patients with LUTS, particularly when invasive, potentially morbid or irreversible treatments are considered.  (Expert Opinion)

17. Clinicians should perform PFS in men when it is important to determine if urodynamic obstruction is present in men with LUTS, particularly when invasive, potentially morbid or irreversible treatments are considered.  (Standard: Evidence Strength: Grade B)

18. Clinicians may perform PFS in women when it is important to determine if obstruction is present.  (Option; Evidence Quality: Grade C)

19. Clinicians may perform videourodynamics in properly selected patients to localize the level of obstruction, particularly for the diagnosis of primary bladder neck obstruction. (Expert Opinion) 

Purpose

Lower urinary tract symptoms (LUTS), which include urinary incontinence, are a common and significant source of impaired quality of life and comorbidity in large numbers of adults and children. Commonly, patients presenting with LUTS have overlapping symptoms and conditions, making an isolated or homogeneous source of symptoms rare. Clinicians evaluating these disorders collectively utilize history, physical examination, questionnaires and pad testing data in the evaluation of symptoms.

Urodynamics (UDS) is the dynamic study of the transport, storage and evacuation of urine. UDS is an interactive diagnostic study of the lower urinary tract composed of a number of tests that can be used to obtain functional information about urine storage and emptying. Physical examination and endoscopic evaluation are integral in determining the etiology of complex LUTS. However, urinary symptoms and physical findings often do not adequately predict the pathophysiology of LUTS. Following these assessments, urodynamic questions (What is the information I need to obtain from UDS? and What is the most appropriate UDS technique to obtain these results?) may be formulated, and subsequent completion of the most appropriate UDS test(s) often aid in diagnosis. The main goal of UDS is to reproduce the patients' symptoms and determine the cause of these symptoms by urodynamic measurements or observations.  Furthermore, some conditions have minimal or no symptoms, yet urodynamic testing may be appropriate (e.g., certain neurological disorders). However, the current literature is deficient in Level-1 evidence, which could elucidate the precise indications for urodynamic testing.  Many would agree that conservative, empiric, non-invasive treatment of LUTS without urodynamic testing is an appropriate practice.

This guideline is intended to review the literature regarding the use of urodynamic testing in common LUT conditions and present the clinician with principles of application and technique.  As UDS is only one part of the comprehensive evaluation of LUTS, these findings are intended to assist the clinician in the appropriate selection of urodynamic tests following an appropriate evaluation and symptom characterization. At this point, the clinician may utilize the principles in these guidelines to formulate urodynamic questions and select the appropriate urodynamic tests. The literature is inconclusive and "pure" symptomatalogy is rare; therefore, this guideline will not specify whether UDS testing should be done routinely in SUI or LUTS. The intent of this guideline is to identify concurrent factors and conditions in these patients and make recommendations regarding appropriate urodynamic techniques in these settings.

Methodology

A systematic review was conducted to identify published articles relevant to the use of UDS in patients with various urologic conditions, disorders and symptoms. Literature searches were performed on English-language publications using the MEDLINE® and EMBASE databases from January 1, 1990 to March 10, 2011 using the terms "urodynamics," "stress incontinence," mixed incontinence," "urge incontinence," "lower urinary tract dysfunction," "LUTS," "LUTD" as well as key words related to pelvic organ prolapse, and various neurological diseases and key words capturing the various urodynamic tests known to be used in patients suspected or known to have these conditions. For certain questions, the searches only covered studies published between January 1, 2000 and March 10, 2011. The latter includes questions relating to utility of cystometry for stress/urgency incontinence/mixed incontinence, LUTS or pelvic organ prolapse, utility of EMG for LUTS or pelvic organ prolapse and utility of any combination of urodynamic tests for stress/urgency/mixed incontinence or pelvic organ prolapse. Studies published after March 10, 2011 were not included as part of the evidence base considered by the Panel from which evidence-based guideline statements (Standards, Recommendations, Options) were derived. Data from studies published after the literature search cut-off will be incorporated into the next version of this guideline.

Preclinical studies (e.g., animal models), pediatric studies, meeting abstracts, commentary, editorials, non-English language studies and studies of adults with urological conditions and symptoms other than those noted above were excluded. Studies with less than 10 patients were excluded from further evaluation and thus data extraction given the unreliability of the statistical estimates and conclusions that could be derived from them. Studies that did not report data separately for males and females for certain patient populations (e.g., incontinence, pelvic organ prolapse and LUTS) were excluded. Review article references were checked to ensure inclusion of all possibly relevant studies. Multiple reports on the same patient group were carefully examined to ensure inclusion of only non-redundant information.

Urodynamic Tests, Conditions and Outcomes Reviewed During this Process. This systematic review evaluated the following urodynamic tests: post-void residual, uroflowmetry, cystometry, pressure-flow studies, videourodynamics, EMG, urethral function tests (e.g., Valsalva leak point pressure (VLPP), urethral pressure profile) or any combination of the above. The target populations comprised adults with stress incontinence, mixed incontinence, urgency incontinence, LUTS, pelvic organ prolapse or neurogenic bladder. Outcomes of interest were grouped into four categories: diagnosis, prognosis, clinical management decisions or patient outcomes. Any outcome measure that could be classified in one of these categories was considered acceptable for review. A total of 393 studies met the inclusion criteria and addressed some combination of urodynamic tests, target populations and diagnostic categories noted above. Relevant data from these studies were extracted and summarized in evidence tables which comprise part of the full evidence report (available upon request).

Quality of Studies and Determination of Evidence Strength. Quality of individual studies was rated as high, moderate or low based on instruments tailored to specific study designs. Randomized controlled trials (RCTs) were assessed using the Cochrane Risk of Bias tool.1 Conventional diagnostic cohort studies, diagnostic case-control studies or diagnostic case series that presented data on diagnostic test characteristics were evaluated using the QUADAS tool 2 that evaluates the quality of diagnostic accuracy studies. Cohort studies with a comparison of interest were evaluated with the Drug Effectiveness Review Project instrument.3 As there is no widely agreed upon quality assessment tool for case series that do not present data on diagnostic test characteristics, the quality of individual case series was not formally assessed with an instrument. Instead, these studies were labeled as low quality due to their study design.

The categorization of evidence strength is conceptually distinct from the quality of individual studies. Evidence strength refers to the body of evidence available for a particular question and includes consideration of study design, individual study quality, consistency of findings across studies, adequacy of sample sizes and the generalizability of samples, settings and treatments for the purposes of the guideline. The AUA categorizes body of evidence strength as Grade A (well-conducted RCTs or exceptionally strong observational studies), Grade B (RCTs with some weaknesses of procedure or generalizability or generally strong observational studies) or Grade C (observational studies that are inconsistent, have small sample sizes or have other problems that potentially confound interpretation of data). As most of the available evidence consisted of low quality case series, the majority of evidence was considered Grade C.

AUA Nomenclature: Linking Statement Type to Evidence Strength. The AUA nomenclature system explicitly links statement type to body of evidence strength and the Panel's judgment regarding the balance between benefits and risks/burdens.4 Standards are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken based on Grade A or Grade B evidence. Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken based on Grade C evidence. Options are non-directive statements that leave the decision to take an action up to the individual clinician and patient because the balance between benefits and risks/burdens appears relatively equal or unclear; the decision is based on full consideration of the patient's prior clinical history, current quality of life, preferences and values. Options may be supported by Grade A, B, or C evidence.

To formulate evidence-based statements, the Panel used BRIDGE-Wiz (Building Recommendations In a Developer's Guideline Editor), a software application that employs natural language to create and populate a template for guideline statements. It limits verb choices, promotes active voice and incorporates decidability and executability checks to ensure creation of statements that are actionable by end users.5

In some instances, the review revealed insufficient publications to address certain questions from an evidence basis; therefore, some statements are provided as Clinical Principles or as Expert Opinion with consensus achieved using a modified Delphi technique if differences of opinion emerged.6 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 be no evidence.

Limitations of the Literature. The Panel proceeded with full awareness of the limitations of the urodynamics literature. These limitations include: poorly-defined or heterogeneous patient groups, small sample sizes, lack of studies with diagnostically accurate data, lack of controlled studies with patient outcome data and the use of a variety of outcome measures. Overall, these difficulties precluded use of meta-analytic procedures or other quantitative analyses. Instead, narrative syntheses were used to summarize the evidence for the questions of interest.

Peer Review. This document was submitted for peer review to 84 urologists and other healthcare professionals, and 39 provided input. After the final revisions were made, based upon the peer review process, the document was submitted to and approved by the Practice Guidelines Committee (PGC) and the Board of Directors of the American Urological Association (AUA). Peer review comments are available upon request.

Background

Description of tests. The urodynamic tests considered by the panel for this guideline are described below. All urodynamic tests and related nomenclature are consistent with International Continence Society (ICS) terminology where applicable.

Post-void residual (PVR) is the volume of urine left in the bladder at the completion of micturition. This can be measured by ultrasound or catheterization.

Uroflowmetry is the measurement of the rate of urine flow over time.

Cystometry is the method by which the pressure/volume relationship of the bladder is measured during bladder filling.  Measurements obtained during cystometry include bladder sensations, compliance, bladder capacity and the presence or absence of detrusor overactivity (DO).

Electromyography (EMG) is the study of the electronic potentials produced by the depolarization of muscle membranes. In most UDS tests, EMG measurement of the striated sphincteric muscles of the perineum is done to evaluate possible abnormalities of perineal muscle function that are often associated with lower urinary tract symptoms and dysfunction.

Pressure flow studies (PFS) measure the relationship between pressure in the bladder and urine flow rate during bladder emptying.

Videourodynamic studies (VUDS) include the addition of simultaneous imaging (usually fluoroscopy) during cystometry and/or PFS.

Abdominal leak point pressure (ALPP) or Valsalva leak point pressure (VLPP) is a measurement of urethral function or outlet competence and is the intravesical pressure at which urine leakage occurs due to increased abdominal pressure in the absence of a detrusor contraction.

Urethral pressure profile is the continuous measurement of the fluid pressure needed to just open a closed urethra.

Maximum urethral closure pressure (MUCP) is the maximum difference between the urethral pressure and the intravesical pressure.

Utility in clinical practice.  The utility of UDS in clinical practice is not well-defined and, as noted earlier, level-1 evidence regarding universal indications for UDS is scant.  The conduction of well-designed RCTs is challenged by lower levels of evidence and expert opinion that strongly suggests clinical utility and, more importantly, the potential risks of implementing empiric therapies without complete evaluation. Low pressure storage of urine is necessary in order to protect the upper urinary tracts and complete evacuation of urine in the appropriate setting is important. A number of conditions can affect and disrupt proper LUT function.  Under these circumstances, UDS can offer objective measurements of bladder and urethral function to elucidate the diagnosis and guide treatment.

Given the current status of the literature, it is essential that, prior to proceeding with an invasive UDS study, the clinician has a clear question and indication for performing the test as well as an intention to utilize information gleaned from the study to guide therapy.  The UDS study should be tailored to answer specific questions and should be interpreted in the context of the specific patient's history and presentation.  Two clear categories of patients who may benefit from UDS studies include: (1) those in whom information beyond that obtained by a history, physical examination and basic tests is necessary in order to make an accurate diagnosis and direct therapeutic decisions, and (2) those whose LUT condition may have the potential to cause deleterious and irreversible effects on the upper urinary tracts.  Marked functional and anatomic abnormalities can be present even in the absence of concomitant proportionate symptoms, particularly in patients with neurologic disease.

In general, the clinical utility of UDS has been nicely summarized for the following situations: (1) to identify factors contributing to LUT dysfunction and assess their relevance, (2) to predict the consequences of LUT dysfunction on the upper tracts, (3) to predict the consequences and outcomes of therapeutic intervention, (4) to confirm and/or understand the effects of interventional techniques and (5) to investigate the reasons for failure of a treatment or treatments.7

In clinical practice, the role of invasive UDS testing is not clearly defined.  Urologists generally accept that conservative or empiric, non-invasive treatments may be instituted without urodynamic testing. Many types of urodynamic testing require urethral catheterization and include cystometry, PFS and VUDS including urethral function testing. Such testing subjects patients to risks of urethral instrumentation including infection, urethral trauma and pain. Thus, the clinician must weigh whether urodynamic tests offer additional diagnostic benefit beyond symptom assessment, physical examination and other diagnostic testing.  Uroflowmetry and ultrasound PVR may be appropriate non-invasive tests given the clinical scenario and the options for treatment. In the evaluation and treatment of LUTS, the literature is scarce and inconsistent with data to elucidate the optimal role of urodynamics in guiding therapy. Whether such testing can improve outcomes with any intervention, including specific surgical procedures, or may improve overall surgical outcomes in uncomplicated patients is not clear.  In more complicated/complex individuals with LUTS, there may be a role for various types of UDS testing in order to exclude complicating factors and potentially guiding therapy.

Description of Conditions. LUTS is a term utilized to represent a multifactorial constellation of nonspecific symptoms that affects both bladder filling and urine storage.  Filling LUTS include urinary frequency, urgency, incontinence and nocturia.  Incontinence is discussed separately from "LUTS" in this document.  Voiding LUTS include slow stream, hesitancy, intermittency, incomplete bladder emptying and post-void or terminal dribbling.  LUTS is considered by some to represent the symptom complex previously referred to as "prostatism," (benign prostatic hyperplasia (BPH), enlarged prostate) and indeed is more commonly, albeit not exclusively, applied to male symptoms. For the purposes of this document, LUTS is applicable to both men and women and encompasses symptoms related to and often occurring secondary to a degree of outlet obstruction whether it be due to prostatic enlargement or a previous anti-incontinence procedure. Also important is the not-so-infrequent situation in which irritative LUTS may co-exist with obstructive LUTS and may cloud the assessment, thereby making diagnosis difficult.

Stress urinary incontinence (SUI) exists as a symptom, sign and condition.  The observation of SUI during urodynamics (urodynamic SUI) is defined as the finding of involuntary leakage during filling cystometry associated with increased intra-abdominal pressure in the absence of a detrusor contraction.  The symptom of SUI is the complaint of involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing.  This is to be differentiated from the sign of SUI, which is the observation of involuntary leakage from the urethra synchronous with effort or physical exertion or on sneezing or coughing.7

SUI may co-exist in the setting of pelvic organ prolapse (POP).  POP is a condition occurring exclusively in females and is defined as the descent of one or more of the anterior vaginal wall, posterior vaginal wall, the uterus (cervix) or the apex of the vagina (vaginal vault or cuff scar after hysterectomy).7  Occult SUI is defined as stress incontinence observed only after the reduction of co-existent prolapse.  A significant proportion of women with high grade POP who do not have the symptom of SUI will be found to have occult SUI.

Overactive bladder (OAB), urgency urinary incontinence (UUI) and mixed urinary incontinence are symptom complexes that include a component of urinary urgency with or without incontinence in the absence of infection or other pathology.  Urgency is the sudden uncontrollable desire to void that is difficult to defer and may or may not be associated with urinary incontinence.  Mixed incontinence is the combination of SUI and urge incontinence (see below).  OAB is defined as a syndrome in which several of the storage-related LUTS coexist with urgency being the principal and essential parameter.  By definition, at least one parameter must exist in addition to the urgency in order to diagnose OAB.  Patients will often describe urinary frequency with low-volume voids.  Nocturia is a more variable part of the OAB complex and usually has a multifactorial etiology. Patients with nocturia as a primary symptom that significantly affects quality of life require separate investigation as to cause and treatment and are beyond the scope of this guideline.

While OAB is a symptom-based diagnosis, DO is a urodynamic diagnosis characterized by an involuntary detrusor contraction during the filling phase of cystometry, which only occurs in a portion of patients with OAB. Although DO is often associated with OAB since its symptoms overlap those of the OAB diagnosis, the terms are not interchangeable, and DO is not required to make the diagnosis of OAB.

There are several theories regarding the pathophysiology of OAB and DO, and it is theorized that not all patients with symptoms of urinary urgency share the same pathophysiology.  The neurogenic hypothesis attributes DO to nerve-mediated excitation of the detrusor muscle.  The myogenic hypothesis suggests that uninhibited contractions occur as a result of spontaneous excitation within the bladder smooth muscle and propagation of these impulses through the bladder wall.  Contributions of the urothelial cells and the afferent pathways have also been explored extensively and continue to be the subject of much scholarly activity.  The afferent A?-fibers are thought to convey bladder filling information and respond to passive bladder distention and active detrusor contractions.  The C-fibers respond to noxious chemical irritation or thermal stimuli.  Inappropriately high activity of any of these fibers may contribute to OAB.

Neurogenic Bladder (NGB) refers to the disturbance of normal bladder function as a result of neurologic disease. Many neurologic conditions can be associated with NGB; however, the more commonly known conditions of which urologists and lower urinary tract specialists should be particularly aware include: spinal cord injury (SCI), multiple sclerosis, Parkinson's disease, stroke/cerebrovascular accident, traumatic brain injury, myelomeningocele (MMC), brain or spinal cord tumor, transverse myelitis, back or spine disease (including herniated disk, cauda equina syndrome), diabetes, peripheral nerve injury and other lower motor neuron diseases. Neurogenic bladder dysfunction can include problems of bladder storage (including ability to maintain continence) as well as bladder emptying and also introduces the concern of NGB-induced damage to the upper genitourinary (GU) tracts as a result of sustained elevation in storage pressures. Damage to the upper tracts can include hydronephrosis and hydroureter, vesico-ureteral reflux, reflux nephropathy, urinary tract infections (UTI) and pyelonephritis. In addition, infectious complications can arise from NGB induced alterations in storage and emptying.

An additional concern specific to patients with NGB is the possible presence of autonomic dysreflexia (AD). AD is usually limited to SCI (T6 level and above) and is considered an exaggerated sympathetic response to afferent visceral or painful stimulation, which can have severe and life threatening consequences. Symptoms of AD include flushing, sweating above the level of injury, headache, severe hypertension and reflex bradycardia that can ultimately be lethal due to intracranial hemorrhage if not recognized or treated appropriately.8 Typical triggers of AD include bladder distention, bowel distention, instrumentation of the lower urinary or GI tract as well as any neurologic noxious stimuli below the level of the SCI. The GU tract instrumentation needed to perform UDS along with the necessary bladder distention are both well-known culprits for triggering AD.  For this reason, the specialist who performs UDS on patients who are at risk of AD must be prepared to monitor, promptly detect and initiate rapid treatment in the event AD occurs.

Stress Urinary Incontinence (SUI)/Prolapse

Guideline Statement 1

Clinicians who are making the diagnosis of urodynamic stress incontinence should assess urethral function. (Recommendation; Evidence Strength: Grade C)

Discussion


Guideline Statement 2

Surgeons considering invasive therapy in patients with SUI should assess PVR urine volume. (Expert Opinion)

Discussion


Guideline Statement 3

Clinicians may perform multi-channel urodynamics in patients with both symptoms and physical findings of stress incontinence who are considering invasive, potentially morbid or irreversible treatments.  (Option; Evidence Strength: Grade C)

Discussion


Guideline Statement 4

Clinicians should perform repeat stress testing with the urethral catheter removed in patients suspected of having SUI who do not demonstrate this finding with the catheter in place during urodynamic testing.  (Recommendation; Evidence Strength: Grade C)

Discussion


Guideline Statement 5

In women with high grade POP but without the symptom of SUI, clinicians should perform stress testing with reduction of the prolapse.  Multi-channel urodynamics with prolapse reduction may be used to assess for occult stress incontinence and detrusor dysfunction in these women with associated LUTS(Option; Evidence Strength: Grade C)

Discussion


Overactive Bladder (OAB), Urgency Urinary Incontinence (UUI), Mixed Incontinence

Guideline Statement 6

Clinicians may perform multi-channel filling cystometry when it is important to determine if altered compliance, detrusor overactivity or other urodynamic abnormalities are present (or not) in patients with urgency incontinence in whom invasive, potentially morbid or irreversible treatments are considered.(Option; Evidence Strength: Grade C)

Discussion


Guideline Statement 7

Clinicians may perform PFS in patients with urgency incontinence after bladder outlet procedures to evaluate for bladder outlet obstruction. (Expert Opinion)

Discussion


Guideline Statement 8

Clinicians should counsel patients with urgency incontinence and mixed incontinence that the absence of DO on a single urodynamic study does not exclude it as a causative agent for their symptoms.(Clinical Principle)

Discussion


Neurogenic Bladder (NGB)

Guideline Statement 9

Clinicians should perform PVR assessment, either as part of complete urodynamic study or separately, during the initial urological evaluation of patients with relevant neurological conditions (such as spinal cord injury and myelomeningocele) and as part of ongoing follow-up when appropriate.  (Standard; Evidence Strength: Grade B).

Discussion


Guideline Statement 10

Clinicians should perform a complex cystometrogram (CMG) during initial urological evaluation of patients with relevant neurological conditions with or without symptoms and as part of ongoing follow-up when appropriate. In patients with other neurologic diseases, physicians may consider CMG as an option in the urological evaluation of patients with LUTS.  (Recommendation; Evidence Strength: Grade C)

Discussion


Guideline Statement 11

Clinicians should perform pressure flow analysis in patients with relevant neurologic disease with or without symptoms, or in patients with other neurologic disease and elevated PVR or urinary symptoms.  (Recommendation, Evidence Strength: Grade C)

Discussion


Guideline Statement 12

When available, clinicians may perform fluoroscopy at the time of urodynamics (videourodynamics) in patients with relevant neurologic disease at risk for neurogenic bladder, or in patients with other neurologic disease and elevated PVR or urinary symptoms. (Recommendation; Evidence Strength: Grade C)

Discussion


Guideline Statement 13

Clinicians should perform EMG in combination with CMG with or without PFS in patients with relevant neurologic disease at risk for neurogenic bladder, or in patients with other neurologic disease and elevated PVR or urinary symptoms. (Recommendation; Evidence Strength: Grade C)

Discussion


LUTS

Guideline Statement 14

Clinicians may perform PVR in patients with LUTS as a safety measure to rule out significant urinary retention both initially and during follow up. (Clinical Principle)

Discussion


Guideline Statement 15

Uroflow may be used by clinicians in the initial and ongoing evaluation of male patients with LUTS that suggest an abnormality of voiding/emptying. (Recommendation; Evidence Strength: Grade C)

Discussion


Guideline Statement 16

Clinicians may perform multi-channel filling cystometry when it is important to determine if DO or other abnormalities of bladder filling/urine storage are present in patients with LUTS, particularly when invasive, potentially morbid or irreversible treatments are considered.  (Expert Opinion)

Discussion


Guideline Statement 17

Clinicians should perform PFS in men when it is important to determine if urodynamic obstruction is present in men with LUTS, particularly when invasive, potentially morbid or irreversible treatments are considered.  (Standard; Evidence Strength: Grade B)

Many studies assessed the use of PFS to predict outcomes of men with LUTS treated with surgical procedures to reduce outlet resistance.95-108  While the results of these studies showed variability regarding the ability of PFS to predict outcomes of surgical procedures to treat benign prostatic obstruction (BPO), the panel concluded that the preponderance of evidence suggests that a diagnosis of obstruction on a PFS predicts a better outcome from surgery than a diagnosis of no obstruction. Therefore, it can be recommended as part of the evaluation of LUTS in men. The panel also believes that despite some limitations, PFS remain the only means of definitively establishing or ruling out the presence of BOO in men. However, it may not always be necessary to confirm urodynamic obstruction prior to proceeding with invasive therapy. Patients should also be made aware of the risks of PFS, which include hematuria, UTI and dysuria as well as some of the diagnostic pitfalls of the studies.

Discussion


Guideline Statement 18

Clinicians may perform PFS in women when it is important to determine if obstruction is present.  (Recommendation; Evidence Quality: Grade C)

Discussion


Guideline Statement 19

Clinicians may perform videourodynamics in properly selected patients to localize the level of obstruction particularly for the diagnosis of primary bladder neck obstruction. (Expert Opinion) 

Discussion


Future Research

UDS is an interactive study that measures lower urinary tract function during urine storage and emptying. However, widespread variability in technique and interpretation of UDS leads to many unanswered questions. For most clinicians, common uncertainties include questions as to the optimal clinical conditions to perform urodynamic testing. Unfortunately, this review and others have found that definitive answers are elusive. Not only does variance in urodynamic testing limit the ability to answer some of these important questions, but we are severely limited by a variance in the practice and reporting of lower urinary tract disorders. To begin to answer these important questions, adherence to terminology and consistency in clinical practice is desperately needed. In this context, the panel cannot stress enough the importance of good urodynamic practice, which emphasizes formulating the urodynamic question, insuring that testing reproduces symptoms, accurately interpreting artifacts and reporting results in the context of the clinical scenario. Consistency and quality of urodynamic practice may ultimately facilitate answering some of these complex questions. As a result, the panel recommends that publishers and editors of manuscripts involving urodynamic studies strictly adhere to good urodynamic practice and terminology.

When performing urodynamic studies for the various clinical conditions reported in this guideline, the panel has recognized a number of important issues, which warrant future research:

SUI. Understanding urethral function is critical to elucidating the etiology of SUI. The current methods of assessing urethral function, including urethral pressure profilometry and VLPP testing, are imperfect and do not consistently correlate with treatment outcomes.  There is an overlap between normal and abnormal values in urethral pressure profile as well as a lack of consensus regarding which method is the optimal test to determine urethral function.  To date, there is a lack of a consistent, standardized method for performance of these tests as well as absolute normative values for these tests. Considerable investigation is needed to standardize the appropriate technique to assess urethral function. In addition, there is a lack of consistent data showing that existing tests predict outcomes with any given intervention for SUI. Further investigation is needed to determine if urethral function tests may accurately predict outcomes of surgical SUI treatment or assist in the appropriate selection of a surgical procedure.

As noted previously, the role and value of invasive UDS in the uncomplicated patient with SUI remains unclear.  Prior groups have recommended such testing prior to surgical intervention in all patients with SUI.118 This recommendation was made despite a lack of evidence that these tests improve overall outcomes, reduce postoperative morbidity (e.g., postoperative voiding dysfunction, de novo urgency or urgency incontinence, and urinary retention) or favorably impact choice of intervention in groups of uncomplicated patients with SUI undergoing preoperative UDS as compared to individuals who do not undergo preoperative UDS testing.  In contrast, the American Urological Association SUI Guidelines Panel characterized UDS as optional in women with uncomplicated SUI.26 Prospective RCTs comparing outcomes in patients undergoing preoperative UDS testing v. those not receiving such testing may be helpful in assessing the utility, safety and value of UDS testing in patients for whom a variety of treatment options exist . Investigation is needed to determine the optimal, cost-effective utilization of urodynamics prior to selection of surgical therapy.

NGB. In patients with NGB, restoring effective bladder emptying and maintenance of continence are only a part of the overall management. Disorders of compliance and high urinary storage pressures may lead to febrile UTI, urinary calculi and renal failure.119 Thus, characterization of the anatomy and function of the lower urinary tract is important in patients with neurogenic disorders. At present, cystometry via catheterization is the predominant technique of measuring bladder function. In these patients at risk for UTI or AD, development of less invasive means of assessing bladder function is desirable. Further research is needed into alternative measurements of bladder function, such as further development of ultrasonic measurement of bladder wall thickness or assessing for BOO via external means.

The concept of high storage pressures and elevated detrusor LPP leading to upper tract deterioration has been reported in myelodysplastic patients with elevated detrusor LPP. It remains unclear whether similar storage pressures place patients with other neurogenic disorders at similar risk. At what point does decreased compliance really cause upper tract changes? Should the urodynamic assessment in these patients be similar? Clearly, in patients with neurogenic bladder, detrusor LPP warnings need to be assessed and validated in various neurological populations; this would facilitate development of treatment protocols. In addition, this may provide insight into another area of needed research – determining the optimal frequency of urodynamic follow-up in patients with "stable" neurogenic bladder. Lastly, it would be useful to identify specific circumstances when decreased compliance may predict a poor outcome for a specific modality of treatment.

VUDS is often utilized in patients with neurogenic bladder, assuming that the anatomic detail will provide additional anatomic information that is of value in treatment. It would be useful to validate the role of fluoroscopy during urodynamics in neurogenic (and other) populations. Although the radiation exposure (dosage) during VUDS is low, some clarification regarding frequency of testing and protocols to minimize radiation dosage in patients who are at risk of chronic exposure to radiography is needed.

Further study is clearly needed to clarify the role of UDS in predicting the outcomes of treatment. Can we stratify patients for the most appropriate therapy based on urodynamic findings?

Urgency and/or Urinary Urge Incontinence. OAB symptoms may occur as a result of increased bladder sensitivity or involuntary contractions of the bladder. This may result in symptoms of urinary urgency, frequency and/or urgency incontinence. UDS may often fail to identify abnormal contractions of the bladder in patients with urgency incontinence. In addition, measurements of urinary sensation are subjective and largely correlated with volume. In patients with urgency incontinence, more study is needed in performing cystometry. Further insight is needed into the optimal filling protocol that is most accurate in diagnosing DO. In addition, clarity is needed to determine if provocative studies should be performed to elicit DO and when those maneuvers are indicated. Lastly, more data are needed to stratify outcomes of treatment based on the presence or absence of DO. Measurement of bladder sensation is largely subjective and does not strongly correlate with urinary urgency. Further study is needed in order to develop better methods of assessing bladder sensation and urinary urgency, perhaps quantified to severity. These measurements should be correlated to treatment outcomes.

In evaluating bladder storage disorders, research is needed to identify alternative methods of quantifying bladder sensation and storage pressures which are more reproducible. This would undoubtedly improve reliability and clinical relevance.

Data are mixed regarding the outcomes of SUI treatment in patients with urodynamic findings of DO or increased bladder sensation. Further insight is clearly needed to assess whether DO or increased bladder sensation is predictive of response to therapy.  Does any risk vary with the different types of treatment or SUI surgery? Additionally, is the urodynamic finding of bladder storage abnormality associated with a higher risk of complications following SUI management?  This information is needed to quantify the role of UDS prior to surgical management of SUI.

LUTS. Patients with various constellations of LUTS may undergo PVR or uroflow testing as non-invasive methods to screen for disorders of bladder emptying. Although very widely utilized in urologic practice, many questions remain regarding the utility of non-invasive testing methods. What is the optimal PVR volume to recommend treatment? Is volume alone adequate, or should treatment decisions be coupled with bladder pressure? In addition, how many PVR assessments should be measured to initiate therapy? If more than one measurement is thought optimal, what is the reproducibility of these measurements? Does elevated PVR predict treatment outcomes or complications? PVR is commonly utilized as the test to diagnose urinary retention. What should be defined as "significant" retention, and what is the optimal setting to recommend intervention? When utilizing uroflowmetry as a screening assessment of emptying, the volume voided is vitally important. Voided volumes of at least 150 ml have been reported to be necessary for the "accuracy" of the study. However, the real relationship between uroflowmetry and voided volume or bladder capacity is poorly understood. Should uroflow be "standardized" to volume on a nomogram chart? This information is needed in order to enhance the clinical accuracy and relevance of uroflow as a screening study. In addition, as a commonly performed screening test, more data are clearly needed to determine if abnormal uroflow studies predict therapeutic outcomes or complications.

PFS are the "definitive" method to assess abnormalities of emptying. In men, the data are not conclusive that PFS predict outcomes of outlet reduction by "prostatectomy." Conclusive study is needed to determine if urodynamic evidence of obstruction is actually predictive of a more favorable outcome to treatment of outlet obstruction. What are the detrusor pressures that absolutely diagnose obstruction, and is there more than one measurement needed? In women, no clear consensus exists regarding the urodynamic criteria of obstruction; determination of such criteria is desirable. Can this be measured by pressure-flow alone, or is some element of video needed? In voiding disorders due to underactive detrusor function, investigation into which parameters actually constitute detrusor underactivity is desirable. Also, in voiding disorders in patients with underactive detrusor function, how can concomitant obstruction be diagnosed? In addition, the precise technique and role of EMG testing remains unclear. Future study regarding technique and correlation to treatments is needed to more adequately determine the role of EMG testing.

When evaluating disorders of emptying, VUDS can be valuable by providing anatomic detail of emptying. PBNO is a VUDS diagnosis and should be considered in young males and women. However, the exact indications for VUDS as opposed to PFS have not been well defined. Further insight is needed to identify patients who would benefit from VUDS.

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