Unabridged version of this Guideline [pdf]
Algorithm associated with this Guideline [pdf]

To cite this guideline:

Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. Published online April 23, 2024. doi:10.1097/JU.0000000000003985. https://www.auajournals.org/doi/10.1097/JU.0000000000003985

Anne Pelletier Cameron, MD; Doreen E. Chung, MD; Elodi J. Dielubanza, MD; Ekene Enemchukwu, MD, MPH; David A. Ginsberg, MD; Brian T. Helfand, MD, PhD; Brian J. Linder, MD; W. Stuart Reynolds, MD, MPH; Eric S. Rovner, MD; Lesley Souter, PhD; Anne M. Suskind, MD, MS; Elizabeth Takacs, MD; Blayne Welk, MD, MSc; Ariana L. Smith, MD

Leila Rahimi, MHS; Lesley Souter, PhD

Purpose

The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of idiopathic non-neurogenic overactive bladder.

Methodology

An electronic search employing OVID was used to systematically search the MEDLINE and EMBASE databases, as well as the Cochrane Library, for systematic reviews and primary studies evaluating diagnosis and treatment of overactive bladder from January 2013 -November 2023. Criteria for inclusion and exclusion of studies were based on the Key Questions and the populations, interventions, comparators, outcomes, timing, types of studies and settings (PICOTS) of interest.  Following the study selection process, 159 studies were included and were used to inform evidence-based recommendation statements.     

GUIDELINE STATEMENTS

Evaluation/Diagnosis

1. In the initial office evaluation of patients presenting with symptoms suggestive of OAB, clinicians should:
   1. obtain a medical history with comprehensive assessment of bladder symptoms,
   2. conduct a physical examination, and
   3. perform a urinalysis to exclude microhematuria and infection.
      (Clinical Principle)

2. Clinicians may offer telemedicine to initially evaluate patients with symptoms suggestive of OAB, with the understanding that a physical exam will not be performed and urinalysis should be obtained at a local laboratory (or recent lab results reviewed, if available). (Expert Opinion)
3. Clinicians may obtain a post-void residual in patients with symptoms suggestive of OAB to exclude incomplete emptying or urinary retention, especially in patients with concomitant voiding or emptying symptoms. (Clinical Principle)
4. Clinicians may obtain a symptom questionnaire and/or a voiding diary in patients with symptoms suggestive of OAB to assist in the diagnosis of OAB, exclude other disorders, ascertain the degree of bother, and/or evaluate treatment response. (Clinical Principle)
5. Clinicians should not routinely perform urodynamics, cystoscopy, or urinary tract imaging in the initial evaluation of patients with OAB. (Clinical Principle)
6. Clinicians may perform advanced testing, such as urodynamics, cystoscopy, or urinary tract imaging in the initial evaluation of patients with OAB when diagnostic uncertainty exists. (Clinical Principle)
7. Clinicians should assess for comorbid conditions in patients with OAB that may contribute to urinary frequency, urgency, and/or urgency urinary incontinence and should educate patients on the role that managing these conditions can have on bladder symptoms. (Expert Opinion)
8. Clinicians may use telemedicine for follow-up visits with patients with OAB. (Expert Opinion)

Shared Decision-Making

9. Clinicians should engage in shared decision-making with patients with OAB taking into consideration the patient’s expressed values, preferences, and treatment goals in order to help them make an informed decision regarding different treatment modalities or to explore the option of no treatment. (Clinical Principle)

Non-Invasive Therapies

10. Clinicians should discuss incontinence management strategies (e.g., pads, diapering, barrier creams) with all patients who have urgency urinary incontinence. (Expert Opinion)
11. Clinicians should offer bladder training to all patients with OAB. (Strong Recommendation; Evidence Level: Grade A)
12. Clinicians should offer behavioral therapies to all patients with OAB. (Clinical Principle)
13. Clinicians may offer select non-invasive therapies to all patients with OAB. (Clinical Principle)
14. In patients with OAB whose symptoms do not adequately respond to monotherapy, clinicians may combine one or more of the following: behavioral therapy, non-invasive therapy, pharmacotherapy, and/or minimally invasive therapies. (Expert Opinion)
15. Clinicians should counsel patients that there is currently insufficient evidence to support the use of nutraceuticals, vitamins, supplements, or herbal remedies in the treatment of OAB. (Expert Opinion)

Pharmacology

16. Clinicians should offer antimuscarinic medications or beta-3 agonists to patients with OAB to improve urinary urgency, frequency, and/or urgency urinary incontinence. (Strong Recommendation; Evidence Level: Grade A)
17. Clinicians should counsel patients with OAB on the side effects of all oral medication options; treatment should be chosen based on side effect profiles and in the context of shared decision-making. (Clinical Principle)
18. Clinicians should discuss the potential risk for developing dementia and cognitive impairment with patients with OAB who are taking, or who are prescribed, antimuscarinic medications. (Clinical Principle)
19. Clinicians should use antimuscarinic medications with extreme caution in patients with OAB who have narrow-angle glaucoma, impaired gastric emptying, or a history of urinary retention. (Clinical Principle)
20. Clinicians should assess patients with OAB who have initiated pharmacotherapy for efficacy and onset of treatment side effects. (Expert Opinion)
21. In patients with OAB who experience intolerable side effects or who do not achieve adequate improvement with an OAB medication, clinicians may offer a different medication in the same class or different class of medication to obtain greater tolerability and/or efficacy. (Clinical Principle)
22. In patients with OAB who do not achieve adequate improvement with a single OAB medication, clinicians may offer combination therapy with a medication from a different class. (Conditional Recommendation; Evidence Level: Grade B)

Minimally Invasive Procedures

23. Clinicians may offer minimally invasive procedures to patients with OAB who are unable or unwilling to undergo behavioral, non-invasive, or pharmacologic therapies. (Clinical Principle)
24. Clinicians may offer patients with OAB, in the context of shared decision-making, minimally invasive therapies without requiring trials of behavioral, non-invasive, or pharmacologic management. (Expert Opinion)
25. In patients with OAB who have an inadequate response to, or have experienced intolerable side effects from, pharmacotherapy or behavioral therapy, clinicians should offer sacral neuromodulation, percutaneous tibial nerve stimulation, and/or intradetrusor botulinum toxin injection. (Moderate Recommendation; Evidence Level: Grade A)
26. Clinicians should measure post-void residual in patients with OAB prior to intradetrusor botulinum toxin injection. (Clinical Principle)
27. Clinicians should obtain a post-void residual in patients with OAB whose symptoms have not adequately improved or have worsened after intradetrusor botulinum toxin injection. (Clinical Principle)
28. Clinicians should discontinue oral medications in patients with OAB who have an appropriate response to a minimally invasive procedure but should restart pharmacotherapy if efficacy is not maintained. (Expert Opinion)
29. Clinicians may perform urodynamics in patients with OAB who do not adequately respond to pharmacotherapy or minimally invasive therapies to further evaluate bladder function and exclude other disorders. (Clinical Principle)

Invasive Therapies

30. The clinician may offer bladder augmentation cystoplasty or urinary diversion in severely impacted patients with OAB who have not responded to all other therapeutic options. (Expert Opinion)

Indwellling Catheters

31. Clinicians should only recommend chronic indwelling urethral or suprapubic catheters to patients with OAB when OAB therapies are contraindicated, ineffective, or no longer desired by the patient and always in the context of shared decision-making due to risk of harm. (Expert Opinion)

OAB and BPH

32. The clinician may offer patients with BPH and bothersome OAB, in the context of shared decision-making, initial management with non-invasive therapies, pharmacotherapy, or minimally invasive therapies. (Expert Opinion)
33. Clinicians may offer patients BPH and OAB monotherapy with antimuscarinic medications or beta-3 agonists, or combination therapy with an alpha blocker and an antimuscarinic medication or beta-3 agonist. (Conditional Recommendation; Evidence Level: Grade B)

Purpose

Overactive bladder (OAB) is defined by the International Continence Society (ICS) as “urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of urinary tract infection (UTI) or other obvious pathology.”  The prevalence of OAB and its impact on quality of life (QoL) across the life span is significant.  Patients with OAB present to several types of providers including primary care, specialty care, physical therapists, and alternative medicine providers.  The purpose of this OAB guideline is to provide evidence-based guidance to all types of clinicians and patients regarding the evaluation, management, and treatment of idiopathic OAB. The guideline informs the reader on valid diagnostic processes and provides an approach to maximizing symptom control and patient QoL through shared decision-making, while minimizing adverse events and burden of disease. The strategies and approaches recommended in this document were derived from evidence-based and consensus-based methods. There is continually expanding literature on OAB; the strategies presented here will require amendments to remain consistent with the highest standards of clinical care. This document was created to serve as a guide for all types of providers who evaluate, manage, and treat patients with OAB, including general practice as well as those who specialize in various branches of medicine and ancillary care.

Methodology

Search and Article Selection

An electronic search employing OVID was used to systematically search the MEDLINE and EMBASE databases, as well as the Cochrane Library, for systematic reviews and primary studies evaluating diagnosis and treatment of OAB using the PICO elements.  During PICO development, panel members submitted landmark studies addressing the Key Questions to the methodologist.  These studies were defined as control articles and were compared with the literature search strategy output; the strategy was subsequently updated as necessary to capture all control articles.  Databases were searched for studies published from January 2013 through November 2023.  In addition to the MEDLINE and EMBASE databases searches, reference lists of included systematic reviews and primary literature were scanned for potentially useful studies. 

All hits from the OVID literature search were input into reference management software (EndNote 21), 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 (RCTs), observational studies, modelling studies with theoretical cohorts, and case-control studies were considered for inclusion in the evidence base.  For all Key Questions, studies had to enrol at least 30 patients per study arm.  Additionally, the Key Question designed to compare pharmacotherapy regimens was limited to RCTs based on a priori knowledge of multiple trials evaluating OAB oral medications.  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 were compared to the PICO criteria.  Eight panel members were paired with the methodologist and completed duplicate full-text study selection of 10% of studies undergoing full-text review.  The dual review-trained the methodologist, who then completed full-text review of the remaining studies.

Data Abstraction 

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

Risk of Bias Assessment

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; their methodological strengths and weaknesses were discussed where relevant.  To evaluate the risk of bias within the identified studies, the Assessment of Multiple Systematic Reviews 2 (AMSTAR-2)¹ tool was used for systematic reviews, the Cochrane Risk of Bias Tool² was used for randomized studies, a Risk of Bias in Non-Randomized Studies – of Intervention (ROBINS-I) ³ was used for observational studies, and Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS 2)⁴ was used for diagnostic accuracy studies.  Additional important quality features, such as study design, comparison type, power of statistical analysis, and sources of funding were extracted for each study.   

Determining the Evidence Strength

The Grading of Recommendations Assessment, Development, and Evaluation (GRADE)⁵ system was used to determine the aggregate evidence quality for each outcome informing Guideline Statements.  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. Assessment is based on the aggregate risk of bias for the evidence base, with limitations introduced as a consequence of inconsistency, indirectness, imprecision, and publication bias across the studies.⁶  Upgrading of evidence is possible if the body of evidence indicates a large effect or if confounding factors would suggest either spurious effects or would reduce the demonstrated effect. 

The American Urological Association (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.  High certainty by GRADE translates to A category strength of evidence, moderate to B, and both low and very low to C. 

Table 1: Strength of Evidence Definition

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 there is no apparent net benefit or harm 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 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 the statement can be applied to most patients in most circumstances, but better evidence could change confidence. Body of evidence strength Grade C in support of a Strong or Moderate Recommendation indicates the statement can be applied to most patients in most circumstances, but better evidence is likely to change confidence. Body of evidence strength Grade C is only rarely used in support of a Strong Recommendation. Conditional Recommendations can also be supported by any evidence strength. When body of evidence strength is Grade A, the statement indicates 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, alternative strategies may be equally reasonable, and better evidence is likely to change confidence.

Where gaps in the evidence existed, Clinical Principles or Expert Opinions are provided via consensus of the Panel. A Clinical Principle is a statement about a component of clinical care 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 based on members' clinical training, experience, knowledge, and judgment for which there may or may not be evidence in the medical literature.

Table 2: AUA Nomenclature Linking Statement Type to Level of Certainty, Magnitude of Benefit or Risk/Burden, and Body of Evidence Strength

Panel Formation

The OAB Guideline Panel was created in 2022 by the American Urological Association Education and Research (AUAER), Inc and 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 through an open nomination process. Additionally, the Panel included patient representation. Funding of the Guideline was provided by the AUA; panel members received no remuneration for their work.

Peer Review

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 treatment of OAB. In addition to reviewers from the AUA PGC, Science and Quality Council (SQC), and Board of Directors (BOD), the document was reviewed by representatives from SUFU and external content experts. A call for reviewers was placed on the AUA website from November 13 - December 4, 2023, 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 and the AUA Public Policy & Advocacy team to open the document further to the patient perspective. The draft guideline document was distributed to 24 nominated peer reviewers, 23 external reviewers (i.e., peer reviewers who responded to the call for comments), and 37 AUA Committee members (PGC, SQC, BOD) and 15 AUA staff.  All peer review comments were blinded and sent to the Panel for review. In total, 57 reviewers provided comments, including 17 external reviewers. At the end of the peer review process, a total of 1039 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, SQC, and BOD and the SUFU Executive Committee for final approval.  

Definitions

The IUGA/ICS joint terminology report⁷ defines OAB as “urinary urgency, usually accompanied by frequency and nocturia, with or without UUI, in the absence of UTI or other obvious pathology.” OAB studies have used varying combinations of these symptoms to identify patients for study inclusion and to define treatment response. These methodologic differences across studies make it challenging to interpret the OAB literature related to epidemiology and treatment. Most OAB studies exclude individuals with urinary symptoms related to neurologic conditions or other identifiable causes such as radiation cystitis; therefore, this guideline is focused on the evaluation and treatment of idiopathic OAB.

Urgency is defined by IUGA/ICS⁷ as the “complaint of a sudden, compelling desire to pass urine which is difficult to defer.” Urgency is considered the hallmark symptom of OAB; however, given its subjective nature, it has proven difficult to precisely define or quantify for research or clinical purposes. Therefore, many studies of OAB treatments have relied upon other measures (e.g., 24-hour urinary frequency, UUI episodes) for inclusion into trials and to measure treatment response.

Increased daytime urinary frequency is defined by IUGA/ICS as the “complaint that micturition occurs more frequently during waking hours than deemed normal.”⁷ The number of daytime voids can be reliably measured with a voiding diary or by self-report. Traditionally, up to seven micturition episodes during waking hours has been considered normal,⁸  but this number is highly variable based upon hours of sleep, fluid intake, comorbid medical conditions, and other factors.

Nocturia is the “complaint of interruption of sleep one or more times because of the need to micturate. Each void is preceded and followed by sleep.”⁷  Like daytime frequency, nocturia is a multifactorial symptom which is often due to factors unrelated to OAB (e.g., excessive nighttime urine production, fluid intake before bed).

UUI is the “complaint of involuntary leakage of urine associated with urgency (i.e., a sudden compelling desire to void).” Incontinence episodes can be measured reliably with a diary or by self-report, and the quantity of urine leakage can be estimated with pad counts.

Epidemiology

In population-based studies, OAB prevalence rates range from 7% to 27% in men, and 9% to 43% in women.^9-16  No clear differences exist between studies conducted in North America versus other populations. Some studies^9-12 report higher prevalence rates in women than men, while others^13-16 found similar rates across genders. However, UUI is consistently more common in women than in men. OAB symptom prevalence and severity tend to increase with age.^{13, 14, 17} A proportion of OAB cases (37-39%) remit during a given year, but the majority of patients have symptoms for years.^{17, 18} To date, few population-based studies have been published directly examining epidemiologic differences across racial/ethnic groups and there is even less data on gender diverse groups.^{19, 20}  Data from the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium’s RISE FOR HEALTH Study will be available later this year and will provide contemporary prevalence estimates for OAB and other lower urinary tract symptoms (LUTS) in an ethnically and racially diverse sample of US women aged 18-100 years.^{21, 22}  It will further inform the concept of bladder health which goes beyond OAB/LUTS to encompass the physical, mental, and social well-being related to the bladder. The study will explore novel risk and protective factors and adaptive behaviors women use to manage their bladders to further advance OAB/LUTS prevention efforts.

This guideline aimed to use “patients with OAB” consistently which is an inclusive term referring to patients of all genders (e.g., cisgender, transgender, genderqueer, nonbinary, etc.) who suffer from OAB. Much of the current literature on OAB provides data only based on patient sex (i.e., only in males or females) and has not collected or reported data on the gender of the people studied.   To be factual, any review of prior published data where only sex is specified, or only binary gender was presented, we will use the data as it is presented in the literature with the terms “male,” female,” “men,” and “women” since it is the only information provided in the data.  The panel also realizes that many bladder symptoms and condition are affected by anatomical and hormonal differences in patients. Hence, when there is a need to specify anatomical or hormonal information, we will use more descriptive terms such as “patients with prostates” or “patients post menopause.”

Patient-Reported Outcomes and OAB

Since OAB is a symptom-based diagnosis, the QoL impact of the symptoms is a critical aspect of the condition. The degree of bother caused by OAB symptoms directly affects OAB care-seeking, treatment intensity, and satisfaction with treatment. Therefore, assessment of patient-reported outcomes (PROs) can be a critical component of OAB management and the most effective means of assessing the patient’s perspective. Numerous questionnaire instruments have been developed to assess symptoms, degree of bother, treatment satisfaction, and health-related QoL in patients with OAB and urinary incontinence. This lack of standardization across the published literature has often limited the comparability and generalizability of outcomes across research studies. To address this, the International Consultation on Incontinence has developed a series of standardized modular questionnaires for pelvic conditions, including OAB.²³ The Lower Urinary Tract Research Network (LURN) developed a comprehensive patient reported LUTS index (LURN-SI-29) for phenotyping that is appropriate for all genders and is available in a short form (LURN-SI-10) for typical clinical use.²⁴  The Panel encourages the development and utilization of standardized PRO tools  in OAB research and clinical practice. The use of validated PRO tools will advance patient-centered comparative effectiveness research and help patients make informed decisions about treatment options.

Impact on Psychosocial Functioning and Quality of Life

The Panel recognizes that OAB constitutes a significant physical, emotional, and economic burden for patients. These burdens include the time and effort required to manage symptoms during daily life as well as the resources required to obtain treatments that may be costly and may present logistical challenges (e.g., cost of prescription medication and pads). The negative impact of OAB symptoms on psychological well-being and QoL also has been well-documented.^25-28 Lack of bladder control can profoundly affect an individual’s ability to travel away from home, perform occupational duties, and engage in social activities. Urinary incontinence may have severe psychological and social consequences, resulting in restricted activities, isolation, and unwillingness to be exposed to environments where access to a bathroom may be difficult. Patients also report negative impact on sexual desire, sexual function, and marital satisfaction. OAB symptoms have also been linked to major depressive disorder. ^{29 30, 31} This negative impact is most evident among older adults (i.e., ≥ 65 years), resulting in significant impairments in QoL,³² including high rates of anxiety and depression, with the majority of patients reporting they have not sought treatment.  Management of OAB symptoms with behavioral approaches, pelvic floor muscle training (PFMT), medications, neuromodulation, and other therapies, balanced against adverse events, costs, and patient compliance, has been reported to improve patient QoL.

Patient Presentation

Symptoms

The hallmark symptom of OAB is bothersome urgency which may be accompanied by UUI.  Often, symptoms of urinary frequency (both daytime and nighttime) are also reported and support a diagnosis of OAB.³³ It is common for patients to have suffered with their symptoms for an extended time before seeking medical advice.³⁴

Differentiation from other conditions  

A diagnosis of nocturnal polyuria (i.e., the production of greater than 20% to 33% of total 24-hour urine output during the period of sleep) is largely age-dependent: >20% for younger individuals and >33% for elderly individuals.³⁵ Nocturnal voids associated with nocturnal polyuria are frequently normal or large volume as opposed to the small volume voids commonly observed in nocturia associated with OAB. Sleep disturbances, vascular and/or cardiac disease, and other medical conditions are often associated with nocturnal polyuria.

OAB can be distinguished from other conditions, such as excess fluid intake (more than eight glasses of water per day),³⁶ with a frequency-volume chart (i.e., a voiding diary). If the patient has urinary frequency because of the high intake volume with normal or large volume voids, then the patient most likely does not have OAB. This can be managed with education and fluid intake management.

The clinical presentation of interstitial cystitis/bladder pain syndrome (IC/BPS) shares the symptoms of urinary frequency and urgency, with or without UUI; however, bladder and/or pelvic pain, including dyspareunia, is a crucial component of this diagnosis.^37-39

Other conditions can contribute to OAB symptoms and should be diagnosed since their treatment can improve OAB symptoms. For example, in the patient transitioning through menopause, genitourinary syndrome of menopause (GSM) can be a contributing factor to urgency and incontinence symptoms. There is some evidence for symptom improvement with the use of vaginal (but not systemic) estrogen.⁴⁰  Similarly, UTI can have similar symptoms as OAB, but generally is acute in onset, of shorter duration, and accompanied by other clues such as dysuria, or suprapubic discomfort and resolved with antibiotics.  LUTS related to neurological conditions such as stroke, Parkinson’s disease, and multiple sclerosis are considered neurogenic lower urinary tract dysfunction (NLUTD) and not idiopathic OAB. The diagnosis and treatment are discussed in The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Diagnosis and Evaluation.⁴¹

What is New About This Guideline

This guideline is not a revision of The Diagnosis and Treatment of Overactive Bladder (non-neurogenic) in Adults: AUA/SUFU Guideline⁴² but is rather a new systematic review of the evidence on the diagnosis and management of this condition.  Some of the statements have remained relatively unchanged; however, significant changes to this iteration of the Guideline include the incorporation of  patients with prostates and a separate analysis of the treatment of men when data was available.  Other changes include a focus on the impact of non-urological contributing factors (e.g., medical comorbidity, obesity, constipation, pelvic floor dysfunction), and significant changes in the recommendations for pharmacotherapy with further recognition of the potential harm of antimuscarinic medications. 

The evidence base used to support this guideline did not  favor the need for a patient with OAB  to proceed with treatment in a stepwise manner going from “first” to “second” to “third line therapy,”  as recommended in previous OAB guidelines.  The “step therapy”⁴³ approach advised that patients cycle through both behavioral and pharmacotherapy before considering advanced therapies.  This guideline instead emphasizes the importance of shared decision-making between the clinician and the patient with OAB to select the best therapy or therapies based on the patient’s needs, desires, and side effect tolerance.  To eliminate the concept of “step therapy,” the Panel has grouped OAB treatment options according to their invasiveness (Table 3) rather than putting them in a specific order and will refer to these treatment categories throughout the document.

There are eight treatment categories:  1. Incontinence management strategies, 2. behavioral therapies, 3. optimization of co-morbidities,  4. non-invasive therapies, 5. pharmacologic therapies, 6. minimally invasive therapies, 7. invasive therapies, and 8. indwelling catheters. This new framework provides a menu of options for patients to select from, including the option to select from multiple treatment categories simultaneously to best suit their individual wishes.

Table 3: Overactive Bladder Treatment Options

Patients with prostates experience OAB nearly as often as those without, but due to the common misconception that all voiding symptoms are attributable to the prostate, they are often underdiagnosed and undertreated for their symptoms.  While some patients with prostates experience symptoms of both benign prostatic hyperplasia (BPH) and OAB, others have OAB alone and would benefit from diagnosis specific treatment.

The term “refractory OAB” is used in the urologic literature, but there is no clear definition of what this means.  A patient can be refractory to behavioral changes, PFMT, pharmacotherapy, or other modalities.  Some studies have used “refractory OAB” to mean refractory to two oral medications for OAB.  Given the ambiguity and lack of consensus of this term we have refrained from using it in this guideline.

In the initial office evaluation of patients presenting with symptoms suggestive of OAB, clinicians should:

a. Obtain a medical history with comprehensive assessment of bladder symptoms,
b. Conduct a physical examination, and
c. Perform a urinalysis to exclude microhematuria and infection.

(Clinical Principle)

Clinicians may offer telemedicine to initially evaluate patients with symptoms suggestive of OAB with the understanding that a physical exam will not be performed and urinalysis should be obtained at a local laboratory (or recent lab results reviewed, if available). (Expert Opinion)

Clinicians may obtain a post-void residual in patients with symptoms suggestive of OAB to exclude incomplete emptying or urinary retention, especially in patients with concomitant voiding or emptying symptoms. (Clinical Principle)

Clinicians may obtain a symptom questionnaire and/or a voiding diary in patients with symptoms suggestive of OAB to assist in the diagnosis of OAB, exclude other disorders, ascertain the degree of bother, and/or evaluate treatment response. (Clinical Principle)

Clinicians should not routinely perform urodynamics, cystoscopy, or urinary tract imaging in the initial evaluation of patients with OAB. (Clinical Principle)

Clinicians may perform advanced testing, such as urodynamics, cystoscopy, or urinary tract imaging in the initial evaluation of patients with OAB when diagnostic uncertainty exists. (Clinical Principle)

Clinicians should assess for comorbid conditions in patients with OAB that may contribute to urinary frequency, urgency, and/or urgency urinary incontinence and should educate patients on the role that managing these conditions can have on bladder symptoms. (Expert Opinion)

Clinicians may use telemedicine for follow-up visits with patients with OAB. (Expert Opinion)

Shared decision-making is a process where clinicians and patients balance the best available medical evidence with patients’ preferences and values to reach a medical decision.⁹⁶  Decision aids are tools (e.g., pamphlets, videos, web-based material) that can help support and facilitate shared  decision-making by presenting clear information to the patient about treatment options, potential benefits, and harms.  Shared decision-making is not simply providing a patient with decision aids such as pamphlets or telling them the best evidence-based recommendations regarding their condition or treatment choices; nor is it providing a menu of options and abandoning the patient to decide alone. Shared decision-making is an interactive patient-clinician dialogue where the clinician shares information and evidence-based recommendations specific to that patient, taking into consideration their health and social situation. The patient shares their values and preferences to the clinician.  Together, once both clinician and patient are informed, they reach a decision on the next best step in care.  This approach recognizes the importance of incorporating patient preferences and values in addition to the clinician’s recommendation into the decision-making process. This differs from the “informed medical model” which is a passive process by which the clinician informs the patient of all the treatment options but withholds a recommendation, leaving the patient to deliberate and make a decision alone. It also differs from the “traditional medical model” where the healthcare professional provides limited information and options, while making the decision for the patient.⁹⁷  Shared decision-making is particularly important in preference-centered health decisions where multiple options exist for the same condition and the clinical outcomes for each decision are relatively equal. In this scenario, the driver of the decision is patient preference.  OAB is one such condition hence the emphasis on the use of shared decision-making in this guideline.  Decision making for OAB treatment is often driven by symptom severity, patient preferences, and values regarding adverse effects.^98-100 

For OAB medication decision-making clinicians and patients may have diverging decisional priorities and decisional control.  The literature is mixed on this topic, in some studies clinicians emphasize benefits whereas patients put more value on minimizing risk and side effects.¹⁰¹ More recent studies found that clinicians prioritize safety and patients place more emphasis on efficacy.¹⁰²  At least two interactive decision-making aids for OAB are under development including OABcare¹⁰³ and Streamlined¹⁰⁴ but few validated are freely available for clinical use.¹⁰⁰   

Shared decision-making can lead to increased satisfaction, patient empowerment, and adherence to therapy, all while improving patient outcomes and reducing decisional conflict.^{105, 106} Shared decision-making in OAB should involve a collaborative process between clinicians and patients to make informed choices about treatment options.¹⁰⁷

Clinicians should engage in shared decision-making with patients with OAB taking into consideration the patient’s expressed values, preferences, and treatment goals in order to help them make an informed decision regarding different treatment modalities or to explore the option of no treatment. (Clinical Principle)

Clinicians should discuss incontinence management strategies (e.g., pads, diapering, barrier creams) with all patients who have urgency urinary incontinence. (Expert Opinion)

Clinicians should offer bladder training to all patients with OAB (Strong Recommendation; Evidence Level: Grade A)

Clinicians should offer behavioral therapies to all patients with OAB. (Clinical Principle)

Clinicians may offer select non-invasive therapies to all patients with OAB. (Clinical Principle)

In patients with OAB whose symptoms do not adequately respond to monotherapy, clinicians may combine one or more of the following: behavioral therapy, non-invasive therapy, pharmacotherapy, and/or minimally invasive therapies. (Expert Opinion)

Clinicians should counsel patients that there is currently insufficient evidence to support the use of nutraceuticals, vitamins, supplements, or herbal remedies in the treatment of patients with OAB. (Expert Opinion)

Clinicians should offer antimuscarinic medications or beta-3 agonists to OAB patients to improve urinary urgency, frequency, and/or urgency urinary incontinence. (Strong Recommendation; Evidence Level: Grade A)

Clinicians should counsel patients with OAB on the side effects of all oral medication options; treatment should be chosen based on side effect profiles and in the context of shared decision-making. (Clinical Principle)

Clinicians should discuss the potential risk for developing dementia and cognitive impairment with patients with OAB who are taking, or who are prescribed, antimuscarinic medications. (Clinical Principle)

Clinicians should use antimuscarinic medications with extreme caution in patients with OAB who have narrow-angle glaucoma, impaired gastric emptying, or a history of urinary retention. (Clinical Principle)

Clinicians should assess patients with OAB who have initiated pharmacotherapy for efficacy and for onset of treatment side effects. (Expert Opinion)

In patients with OAB who experience intolerable side effects or who do not achieve adequate improvement with an OAB medication, clinicians may offer a different medication in the same class or a different class of medication to obtain greater tolerability and/or efficacy. (Clinical Principle)

In patients with OAB who do not achieve adequate improvement with a single OAB medication, clinicians may offer combination therapy with a medication from a different class. (Conditional Recommendation; Evidence Level: Grade B)

Clinicians may offer minimally invasive procedures to patients who are unable or unwilling to undergo behavioral, non-invasive, or pharmacologic therapies. (Clinical Principle)

Clinicians may offer patients with OAB, in the context of shared decision making, minimally invasive therapies without requiring trials of behavioral, non-invasive, or pharmacologic management. (Expert Opinion)

In patients with OAB who have an inadequate response to, or have experienced intolerable side effects from, pharmacotherapy or behavioral therapy, clinicians should offer sacral neuromodulation, percutaneous tibial nerve stimulation, and/or intradetrusor botulinum toxin injection. (Moderate Recommendation; Evidence Level: Grade A)

Clinicians should measure post-void residual in patients with OAB prior to intradetrusor botulinum toxin therapy. (Clinical Principle)

Clinicians should obtain a post-void residual in patients with OAB whose symptoms have not adequately improved or worsened after intradetrusor botulinum toxin injection. (Clinical Principle)

Clinicians should discontinue oral medications in patients with OAB who have an appropriate response to a minimally invasive procedure but should restart pharmacotherapy if efficacy is not maintained. (Expert Opinion)

Clinicians may perform urodynamics in patients with OAB who do not adequately respond to pharmacotherapy or minimally invasive therapies or procedures to further evaluate bladder function and exclude other disorders. (Clinical Principle)

The clinician may offer bladder augmentation cystoplasty or urinary diversion in severely impacted patients with OAB who have not responded to all other therapeutic options. (Expert Opinion)

Clinicians should only recommend chronic indwelling urethral or  suprapubic catheters to patients with OAB when OAB therapies are contraindicated, ineffective, or no longer desired by the patient and always in the context of shared decision-making due to risk of harm. (Expert Opinion)

Clinicians may offer patients with BPH and bothersome OAB, in the context of shared decision-making, initial management with non-invasive therapies, pharmacotherapy, or minimally invasive therapies. (Expert Opinion)

Clinicians should offer patients with BPH and OAB monotherapy with antimuscarinic medications or beta-3 agonists, or combination therapy with an alpha blocker and an antimuscarinic medication or beta-3 agonist. (Conditional Recommendation; Evidence Level: Grade B)

OAB is a symptom-based diagnosis that is made after clinical evaluation has excluded other causes.  Although the diagnosis is typically straightforward, the ideal treatment remains elusive, and management rather than cure is the goal.

There is no gold standard therapy for OAB since no single treatment is universally effective.  This is because OAB is multifactorial, and we lack information on all the etiologies and the pathophysiologic mechanisms contributing to the symptom complex.  Experts in bladder health have difficulty consolidating the root causes of the condition²⁷² and localizing whether it lies inside the bladder itself or in the pathways between the brain and the bladder or both.

Use of a multidimensional approach to care addresses the multifactorial nature of OAB 

There are many proposed pathophysiological mechanisms including: afferent or efferent nerve dysfunction; detrusor muscle disease; detrusor mucosal hypersensitivity; pelvic floor dysfunction; other pelvic organ anatomic distortion; the microbiome; and alterations in the central nervous system. It is also possible that OAB is simply a precursor of other aging conditions, such as cognitive decline due to loss of frontal cortex inhibition.  Several receptors both in the mucosa (urothelium) and the muscle (detrusor) have been implicated in OAB.  We currently target muscarinic receptors and β3receptors with our existing two classes of pharmacotherapy (antimuscarinic medications and β3agonists, respectively), but there remains untapped potential of other mechanisms including cannabinoid and purinergic receptors.²⁷³ Future drug development will yield more effective medical therapy for OAB with greater tolerability and less financial toxicity.

There exist many known risk factors for OAB but those that are most obvious such as age and sex assigned at birth are not modifiable.²⁷⁴  For others such as obesity and smoking, we need to educate the general public on their association OAB and strategies for weight control and smoking cessation.  The PLUS research consortium is a transdisciplinary approach aiming to promote bladder health and prevent LUTS such as OAB in women across the lifespan.  They are working towards defining the construct of “bladder health” as well as measures to assess this. Their RISE FOR HEALTH study²¹ will focus on the prevalence of bladder health in women and assess risk and protective factors that may exist, and this information will be used for educational strategies to improve bladder health promotion and well-being across the life course.  The scientific community anxiously awaits results for this study.

Independent researchers are making strides towards better understanding of OAB.  LURN was formed to improve the understanding of patients with LUTS through deep phenotyping and longitudinal study of a large cohort of one thousand patients of all genders with LUTS.²⁷⁵ This first study (LURN1) improved our knowledge on the overlap of various LUTS conditions, central nervous system differences, and treatment outcome, and provided clustering analysis to better define novel symptom complexes.²⁷²  A second cohort (LURN2) is underway solely recruiting patients with OAB given that this disorder was the most enigmatic.  We expect even deeper phenotyping results with more information on the impact of behavior, sleep, physical activity, consumption, and longitudinal symptom change.  We hope that there will be actionable results to improve patient care.

Knowledge regarding the pathophysiology of OAB that is refractory to current treatment options is also lacking.  Why do some patients respond to medical therapy, yet others do not?  Which will respond to neuromodulation or neurotoxins?  Are there potential urinary or serum biomarkers that would predict resistance to pharmacotherapy and guide the practitioner directly to more advanced therapy?  Are there patient factors such as concomitant diseases or physical exam findings that can provide clarity?  Will MRI, fMRI, or other central nervous system assessments help with diagnosis or treatment selection?  Our current diagnostic tools including UDS have not been able to predict response to medical therapy nor to any of the minimally invasive treatments.  There has been nascent work to predict response to antimuscarinic medications using machine learning algorithms, but these tools have not been widely adopted.²⁷⁶  Although UDS are very helpful at identifying other LUTS such as stress incontinence or BOO in patients with confusing presentations, in patients with only OAB they often reveal no objective abnormalities or distinguishing characteristics to guide therapy.  There are no pathognomonic findings on UDS to diagnose OAB, though many patients report early sensations of fullness or sensory urgency and a subset will experience DO.  A normal study is relatively common especially among women⁵⁰and UDS parameters do not correlate with symptom severity or patient reported symptoms scores.²⁷⁷ There are clearly functional issues of the lower urinary tract implicated in OAB and further refinement of UDS and other diagnostic modalities will hopefully shed some light on how we can use this valuable tool better. 

Research needs for treatment

Behavioral modifications and non-invasive treatments have been well studied and are relatively effective particularly in milder cases.  Unfortunately, many of these are time consuming or difficult to implement for patients, particularly if trying to implement more than one.  Adherence is limited by self-efficacy and discipline.  Should they limit caffeine, or would pelvic floor physical therapy be more effective, or do they need to change the rate of their fluid intake?  Having individualized recommendations to give a patient that would be more effective in their particular situation would likely be more accepted by patients and be less burdensome than trying a long list of therapies.  Phenotyping our patients for both the biological components of their OAB and their psychological attributes as a patient will allow us to deliver personalized care, optimizing and expediting outcomes.

Medical therapy

Medical therapy has been extensively studied yet important question remain unanswered.  Many insurance providers mandate step therapy trialing one or more antimuscarinic medications before other therapies will be approved.  The assumption, since most trials of minimally invasive therapies enroll participants with OAB who had an inadequate response to medical therapy, is that medications must be trialed and failed in order to move to other treatments.  Scant evidence exists on success of these more advanced therapies in the treatment-naïve patient and this question should be answered since many patients do not want to take a series of potentially harmful or costly medications for the rest of their lives and would rather move to non-pharmacologic means.⁴³   Given the lack of evidence we need to provide better choices for our patients and engage in shared decision-making not make them trial medications they have no intention of continuing.  Patients unwilling to take medications are being lost to follow up, and not being given the choice of advanced therapies, thus choosing nothing and continuing to experience their OAB symptoms.

A key question created by the Panel that could not be answered with the available literature was: at what timepoint (in hours or days) after administration of OAB pharmacotherapy is maximum symptoms control achieved?  Most studies assessed patient response at twelve weeks of follow-up but given that these medications achieve steady state serum concentrations within days it does not seem reasonable to expect a patient to take a medication for three months before assessing efficacy.  Patients already wait excessively long periods of time before progressing to more effective treatment and long delays in decision-making lead to patient frustration and most discontinue on their own and stop seeking care for their problem.  More granular studies on exactly when efficacy peaks and side effects of medications stabilize would help patients progress to other treatments if these fail. 

Minimally invasive treatment

A difficulty barrier in patients with OAB undertaking minimally invasive therapies is the discordance between research defined success of a procedure, which is currently 50% improved and what patients with OAB are seeking.  It is difficult to counsel patients with data being focused on such a low bar for treatment success.  This is perhaps a sign that we have much work to do to better define this problem. 

A key question that the Panel could not find sufficient evidence to provide a statement was on the comparative efficacy of minimally invasive treatments.  It is a logical solution to progress to BTX when oral agents fail.  Unfortunately, just as there is no equipoise with pharmacotherapy, there remain no testing or clear patient factor that will guide choices of what was previously termed ”third line” therapy since there is equivocal or absent data on effectiveness between options.²⁷⁸ No RCTs compare tibial stimulation to any “third-line” therapy, and the only study on BTX compared to SNM was exclusively in women and utilized a higher dosage (200U) of BTX that is not FDA approved for idiopathic OAB (ROSETTA).^{221, 222}  Unless a patient has comorbid conditions such as fecal incontinence or incomplete bladder emptying on top of OAB where neuromodulation can have dual benefits, this remains a preference sensitive decision. As such, decision making often rests on avoidance of side effects or complications since no data on comparative efficacy exists.

A key question of how the severity of OAB symptoms impacts the success of minimally invasive procedures could also not be answered. Although this is a simple parameter to measure with symptoms scores, voiding diaries and/or pad weights/counts, providers have no clear guidance on which treatments to recommend for the most severe patients.  This is a critical research question since these severe patients should not have their treatment strategy picked nearly at random but should start with the most effective modality. 

Another significant dilemma facing clinicians is how to proceed when a minimally invasive option fails. It is easy to simply try whatever option that has not been tried as the next step, which is a “kitchen sink approach” to this problem but data is sparse on the effectiveness of this strategy and chances of success diminish with each failed attempt.²⁷⁹ The data suggests that SNM after failed BTX is relatively successful,²²⁶  but the reverse is not true²⁷⁹ and no data exists on PTNS failures or its ability to treat SNM or BTX failures.   

Many groups of patients with OAB remain poorly studied: men, racial and ethnic minorities, and older adults.  Older adults, and in particular the frail older adults, have a high prevalence of OAB and suffer disproportionately with the consequences of OAB including a higher risk of falls, skin breakdown, higher risk of nursing home admission²⁸⁰ and are more sensitive to side effects from all of the treatments offered.  This population also suffers disproportionately from detrusor underactivity and are at risk of poor emptying. There is also emerging evidence on widespread disparities in care across racial and ethnic minorities and treatment disparities are particularly evident in access to minimally invasive treatments for OAB.¹⁹

Emerging data on the potential cognitive effects of antimuscarinics and their association with dementia have been highly publicized in the lay press and are well known to patients.^{199, 281} These associations need validations and further study both in younger patients who may be taking such medications for long periods and in older frail adults who may be the most vulnerable to cognitive decline.  Older adults are often excluded from research studies due to the inherent challenge in including people with comorbidities and at higher risk of side effects.  This is precisely the reason this group needs to be included in research since these patients are often the most in need of these therapies in the real world.

The evidence for success of minimally invasive treatments is emerging for older adults but requires much more effort to better counsel these more vulnerable patients with OAB.  A large systematic review on the success of botulinum toxin for OAB on the elderly did not identify results by age.²⁸²  Where information does exist, it suggests that greater age and functional comorbidity are both associated with reduced likelihood of 50% improvement and less patient satisfaction with this therapy.²⁸³  There is also concerns about retention being more common and more prolonged in older women.^284-286  The RELIEF study Reduced-dose BTX for urgency Incontinence among Older Females (RELIEF study Clinical Trial Registry Number: NCT05512039; Unique Protocol ID: STUDY02001338) is an ongoing randomized controlled trial that will compare treatment of UUI among women ≥ 70 years of age with low-dose (50 unit) versus standard-dose (100 unit) bladder BTX injection to assess if this lower dose is more appropriate in older women.  This study will also include analysis of heterogeneity of treatment effect by frailty status.

Men have remained almost unstudied on their response to minimally invasive treatments.  Medical therapies including combinations of BPH and OAB therapies and behavioral therapies combined with medical therapy have been well studied and are included in the systematic review for this guideline, however the literature on more advanced treatments is sparse. 

In a recent systematic review of OAB therapy in men the entirety of the literature that stratified results to separate data between men and women found that for PTNS there is only data on 187 men total (7.6% of the populations studied).  None of the papers included had more than 20% of men in their population and most had <5% or zero and none presented sub analysis of success in men.^{228, 287}  For SNM the data on men remains equally sparse with only 10% of the studied population being male among nine studies (n=1181) that reported results of the testing or implantation.²⁸⁸ Studies do suggest that while men respond symptomatically during test phase similarly  to women²⁸⁹ they are less likely to proceed to SNM implantation.  It is not that men are not receiving this therapy since in population studies using the California Office of Statewide Planning and Development ambulatory surgery database 23% of SNM trials were in men (n=630) and male gender was a predictor of failure.²⁹⁰ With such small numbers it is unclear why men fare poorly with this therapy and more importantly how can we do better.  

BTX bladder injections have actually been studied in men with one study exclusively in men receiving BTX showed robust improvement in 62% of men but 69% of the cohort declined to receive a second injection.²⁹¹ Compared to women, men receiving BTX also had a greater elevation in PVR and a higher incidence of need to CIC.²⁴¹

The diagnosis and management of OAB is complex, research has not identified a unifying pathophysiology nor has diagnostic testing lead to reliable patterns that can guide treatment. Nascent research has focused on phenotyping OAB and identifying predictors of treatment outcomes.  Incorporating these elements into the shared decision-making model can help clinicians and patients select the best treatment modality and improve patient outcomes.  Each step presents an open opportunity for additional research. One thing is certain, we should strive for upfront and clear communication with patients regarding OAB as a poorly understood and chronic syndrome, with interventions designed to mitigate symptoms, rather than to ‘treat or resolve’ an underlying condition. This may help reinforce the multi-modal symptom management strategy that may cycle through treatments throughout the life course. Shared decision-making should include a plan of care with emphasis on multiple modalities that are acceptable to the patient to optimize response.

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