Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline E. Ann Gormley, Deborah J. Lightner, Kathryn L. Burgio, Toby C. Chai, J. Quentin Clemens, Daniel J. Culkin, Anurag Kumar Das, Harris Emilio Foster, Jr., Harriette Miles Scarpero, Christopher D. Tessier, Sandip Prasan Vasavada From the American Urological Association Education and Research, Inc., Linthicum, Maryland, and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction Purpose: The purpose of this guideline is to provide a clinical framework for the Abbreviations diagnosis and treatment of non-neurogenic overactive bladder (OAB). and Acronyms Materials and Methods: The primary source of evidence for this guideline is the AE ϭ adverse event systematic review and data extraction conducted as part of the Agency for ER ϭ extended release Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assess- ϭ ment Number 187 titled Treatment of Overactive Bladder in Women (2009). That FDA Food and Drug report searched PubMed, MEDLINE®, EMBASE and CINAHL for English- Administration language studies published from January 1966 to October 2008. The AUA IR ϭ immediate release conducted additional literature searches to capture treatments not covered in OAB ϭ overactive bladder detail by the AHRQ report and relevant articles published between October PTNS ϭ peripheral tibial nerve 2008 and December 2011. The review yielded an evidence base of 151 treat- stimulation ment articles after application of inclusion/exclusion criteria. When sufficient PVR ϭ post-void residual evidence existed, the body of evidence for a particular treatment was assigned QoL ϭ quality of life a strength rating of A (high), B (moderate) or C (low). Additional treatment SNS ϭ sacral neuromodulation information is provided as Clinical Principles and Expert Opinions when insuf- ϭ ficient evidence existed. UTI urinary tract infection Results: The evidence-based guideline statements are provided for diagnosis and overall management of the adult with OAB symptoms as well as for various The complete guideline is available at http:// treatments. The panel identified first through third line treatments as well as www.auanet.org/content/media/OAB_guideline. pdf. non-FDA approved, rarely applicable and treatments that should not be offered. This document is being printed as submission Conclusions: The evidence-based statements are provided for diagnosis and without independent editorial or peer review by overall management of OAB, as well as for the various treatments. Diagnosis and the Editors of The Journal of Urology®. treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable. Key Words: urinary bladder, overactive; urinary bladder; urinary incontinence; nocturia; guideline SECTION 1: PURPOSE while minimizing adverse events and THIS guideline’s purpose is to direct spe- patient burden. The most effective ap- cialist and non-specialist clinicians and proach for a particular patient is best patients regarding how to recognize non- determined by the individual clinician neurogenic overactive bladder, conduct a and patient. As the science relevant to valid diagnostic process and establish OAB improves, Guideline amendment treatment goals that maximize symp- will assure the highest contemporary tom control and patient quality of life clinical standards. 0022-5347/12/1886-2455/0 http://dx.doi.org/10.1016/j.juro.2012.09.079 ® THE JOURNAL OF UROLOGY Vol. 188, 2455-2463, December 2012 www.jurology.com 2455 © 2012 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH,INC. Printed in U.S.A. 2456 AUA/SUFU GUIDELINE ON OVERACTIVE BLADDER SECTION 2: METHODOLOGY parameters, patient characteristics, AEs and primary out- The primary evidential source for this guideline was the comes were extracted. systematic review and data extraction conducted by the Limitations of the Literature Agency for Healthcare Research and Quality) producing There are significant limitations to the OAB literature. Evidence Report/Technology Assessment Number 187 ti- For example, despite the relatively large number of ran- 1 tled Treatment of Overactive Bladder in Women. Studies domized controlled trials with placebo control groups and focusing on males, nocturia and the use of neuromodula- randomized designs with active controls that assessed tion therapies, including sacral neuromodulation, periph- pharmacologic OAB treatments, the overwhelming major- eral (or posterior) tibial nerve stimulation and intravesical ity of trials followed patients for only 12 weeks. This onabotulinumtoxinA to treat non-neurogenic OAB pa- presents a severe limitation of the literature as OAB is a tients were added to the database. The AUA performed its condition requiring long-term treatment. own qualitative and quantitative analyses of these ex- For a complete discussion of the methodology and evi- tracted data. dence grading, please refer to the full-length version of OAB Diagnosis this guideline available at http://www.auanet.org/content/ The review revealed insufficient evidence-based publica- media/OAB_guideline.pdf. tions to address diagnosis; the diagnosis portions of the algorithm (see figure) are provided as Clinical Principles SECTION 3: BACKGROUND or as Expert Opinions.AClinical Principle is a statement about a component of clinical care that is widely agreed OAB is a clinical diagnosis defined by the Interna- upon by urologists or other expert clinicians for which tional Continence Society as the presence of “urinary there may or may not be evidence in the medical litera- urgency, usually accompanied by frequency and noc- ture. Expert Opinion refers to a statement achieved by turia, with or without urgency urinary incontinence, consensus of the Panel that is based on members’ clinical in the absence of a urinary tract infection (UTI) or training, experience, knowledge and judgment for which other obvious pathology.”2 Methodological differences there is no evidence. across studies challenge any interpretation of the OAB OAB Treatment literature related to epidemiology and treatment. Most A total of 151 articles met the treatment inclusion criteria, studies of OAB, including this guideline, exclude indi- judged a sufficient evidence base to construct the majority viduals with symptoms related to neurologic condi- of the treatment algorithm. Data on study type, treatment tions. Diagnosis & Treatment Algorithm: AUA Guideline on Non-Neurogenic Overactive Bladder in Adults. Diagnosis unclear or +/- urine culture, post-void Not OAB or Complicated History and Physical; Urinalysis additional information needed residual, bladder diary, and/or OAB; treat or refer symptom questionnaires Signs/symptoms of OAB, (-) urine microscopy Signs/symptoms of OAB Patient education: - Normal urinary tract function - Benefits/risks of treatment alternatives - Agree on treatment goals Follow-up for efficacy Patient desires treatment and/or and adverse events treatment is in patient’s best interests Behavioral Treatments In extremely rare cases, Treatment goals met (consider adding anti-muscarinic if partially effective) consider urinary diversion or augmentation cystoplasty Treatment goals not met; Patient desires further treatment and/or further treatment in patient’s best interests Anti-muscarinics with active management of adverse events (e.g., dry mouth, constipation); consider dose modification or alternate anti-muscarinic if effective but adverse events are intolerable Treatment goals not met; Patient desires further treatment and/or further treatment in patient’s best interests Consider in carefully-selected patients (multiple therapies may be tried but they should not be combined): Signs/symptoms consistent FDA-Approved: Non-FDA-Approved: Reassess and/or refer; consider urine culture, post-void residual, with OAB diagnosis bladder diary, symptom questionnaires, other diagnostic procedures • Sacral neuromodulation (SNS) or • Intradetrusor as necessary for differentiation • Percutaneous tibial nerve onabotulinumtoxinA stimulation (PTNS) or The complete OAB Guideline is available at www.AUAnet.org/Guidelines. This resource is supported by an educational grant from Astellas Scientific and Medical Affairs, Inc. Diagnosis and treatment algorithm AUA/SUFU GUIDELINE ON OVERACTIVE BLADDER 2457 Urgency is the “complaint of a sudden, compelling SECTION 5: DIAGNOSIS desire to pass urine which is difficult to defer.”2 The Diagnostic Approach Urgency is the hallmark symptom of OAB, but it has The section titled Diagnosis is based on Clinical Prin- proven difficult to precisely define or to characterize for research or clinical purposes. Therefore, many ciples or Expert Opinions with consensus achieved studies of OAB treatment response have relied upon using a modified Delphi technique when differences of other measures (eg, number of voids, number of opinion emerged. This section is intended to provide incontinence episodes). clinicians and patients with a framework for deter- Urinary frequency can be reliably measured with mining whether a diagnosis of OAB is appropriate; it a voiding diary. Traditionally, up to seven micturi- is not intended to replace the judgment and experi- tion episodes during waking hours has been consid- ence of the individual clinician faced with a partic- ered normal,3 but this number is highly variable ular patient. based upon hours of sleep, fluid intake, comorbid 1. The clinician should engage in a diagnos- medical conditions and