Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of non-neurogenic overactive bladder (OAB). MATERIALS & METHODS: The primary source of evidence for the original version of this guideline was the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report was supplemented with additional searches capturing literature published through December 2011. Following initial publication, this guideline underwent amendment in 2014 and 2018. The current document reflects relevant literature published through October 2018. RESULTS: 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). Such statements are provided as Standards, Recommendations, or Options. In instances of insufficient evidence, additional guidance information is provided as Clinical Principles and Expert Opinions. CONCLUSIONS: The evidence-based statements are provided for diagnosis and overall management of OAB, as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable.

Cost profiles and budget impact of rechargeable versus non-rechargeable sacral neuromodulation devices in the treatment of overactive bladder syndrome.

OBJECTIVES: Sacral neuromodulation (SNM) is a guideline-recommended third-line treatment option for managing overactive bladder. Current SNM devices are not rechargeable, and require neurostimulator replacement every 3-6 years. Our study objective was to assess potential cost effects to payers of adopting a rechargeable SNM neurostimulator device. METHODS: We constructed a cost-consequence model to estimate the costs of long-term SNM-treatment with a rechargeable versus non-rechargeable device. Costs were considered from the payer perspective at 2015 reimbursement levels. Adverse events, therapy discontinuation, and programming rates were based on the latest published data. Neurostimulator longevity was assumed to be 4.4 and 10.0 years for non-rechargeable and rechargeable devices, respectively. A 15-year horizon was modeled, with costs discounted at 3% per year. Total budget impact to the United States healthcare system was estimated based on the computed per-patient cost findings. RESULTS: Over the 15-year horizon, per-patient cost of treatment with a non-rechargeable device was $64,111 versus $36,990 with a rechargeable device, resulting in estimated payer cost savings of $27,121. These cost savings were found to be robust across a wide range of scenarios. Longer analysis horizon, younger patient age, and longer rechargeable neurostimulator lifetime were associated with increased cost savings. Over a 15-year horizon, adoption of a rechargeable device strategy was projected to save the United States healthcare system up to $12 billion. CONCLUSIONS: At current reimbursement rates, our analysis suggests that rechargeable neurostimulator SNM technology for managing overactive bladder syndrome may deliver significant cost savings to payers over the course of treatment. Neurourol. Urodynam. 36:727-733, 2017. © 2016 Wiley Periodicals, Inc.

Digital Identity in Academic Urology: Assessment of Female Pelvic Medicine and Reconstructive Surgery, and Opportunity for Improvement.

INTRODUCTION: We describe the digital identity of academic urologists in FPMRS (Female Pelvic Medicine and Reconstructive Surgery) by assessing their visible online information. METHODS: A Google™ search of SUFU (Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction) board members, past presidents and fellowship directors was completed. Hits on the first page of results were categorized as institutional page, group/society page, ratings site, interview/multimedia, journal article or book, social media, professional profile or another person. Sites were subclassified as physician controllable content or not controllable. Descriptive statistics, comparisons among SUFU roles and site type associations were calculated. RESULTS: First page results contained a median (Q1-Q3) of 11 (10-11) hits with 2 (2-3) institutional pages and 1 (1-2) group/society. Ratings sites were frequent returns, with 4 hits (3-5) in 98% of searches (60). Only 1 (1-1) social media, 1 (1-2) professional profile and 1 (1-2) interview/multimedia hits occurred. Overall 6 (5-7) sites were physician controllable content with all but 1 physician having at least 1 such result. Institutional (correlation coefficient -0.38, p = 0.001) or group/society (-0.34, p = 0.023) pages were associated with fewer ratings sites. Group/society pages were 3.41 times more prevalent (mean 11.7% vs 3.44%, p = 0.009) among SUFU board members, while past presidents had 3.03 (6.8% vs 2.3%, p = 0.046) times more journal articles or books and fellowship directors had 1.43 (25.6% vs 18.6%, p = 0.021) times more institutional pages. CONCLUSIONS: For active SUFU members ratings sites comprise a substantial portion of their search results. More online engagement or social media use could increase the visibility of physician controllable content in their digital identities.

Health Resource Utilization and Cost for Patients with Incontinent Overactive Bladder Treated with Anticholinergics.

BACKGROUND: Overactive bladder (OAB) is a common medical condition with significant economic and humanistic burden. Inadequately managed OAB may exacerbate or result in comorbidities such as depression, falls, and urinary tract infections, which can further increase the burden to the health care system. Anticholinergics are often prescribed for management of OAB with urinary incontinence ("wet" OAB). However, research has shown that patient adherence and persistence to anticholinergic therapy is poor, with approximately 80% of patients ultimately failing their first prescribed anticholinergic medication within the first year. While there has been a fair amount of research on the economic burden of OAB, the real-world impact of initiating anticholinergic therapy in patients with wet OAB has not been well studied. OBJECTIVE: To compare falls/fractures, anxiety/depression, health care resource utilization, and health care costs between a cohort of patients with wet OAB who initiated anticholinergic therapy and a matched cohort of patients without OAB. METHODS: This study was a retrospective medical and pharmacy claims analysis. Cases were members of a primary care-based, multispecialty physician medical group located in California. Cases were eligible for inclusion if they were prescribed anticholinergic therapy between January 2008 and May 2012 based on pharmacy claims, had a diagnosis of OAB, and reported having ≥ 1 urinary incontinence episode per day. Wet OAB cases were matched to non-OAB controls in a 1:3 ratio based on sex, age, and observation time. Medical and pharmacy claims data were used to analyze patient comorbidities, as well as track health care resource utilization (HRU) and direct payer costs. RESULTS: After initiating anticholinergic therapy, wet OAB patients had a 46% higher adjusted risk of experiencing falls/fractures (P < 0.001) and a 33% higher adjusted risk of experiencing depression/anxiety (P = 0.022) than non-OAB patients. Wet OAB was significantly associated with increased HRU rates of hospital admissions, outpatient visits, prescriptions filled, and diagnostic tests performed. After adjustment for covariates, total health care cost was 33% higher for wet OAB patients than non-OAB patients, resulting in an increased cost of $1,746 per member per year. CONCLUSIONS: The findings of this research suggest OAB patients who initiate anticholinergic therapy and still experience incontinence are at a greater risk for comorbidities such as falls/fractures and depression/anxiety, and use significantly more health care resources, than patients without OAB. Programs to improve patient monitoring and referrals, the appropriate use of alternative treatments within guidelines, and adherence to evidence-based practice parameters may improve clinical outcomes and decrease HRU for these patients. DISCLOSURES: This study was sponsored by Allergan, Irvine, California, which reviewed and approved the final manuscript. At the time of the study, Yehoshua had received a fellowship at the University of Arizona, which was funded by Allergan. Yehoshua, Joshi, and Campbell are employees of Allergan. Vasaveda has received consulting fees from Allergan, Medtronic, and Boston Scientific. Chancelor has received consulting fees from Allergan and Medtronic. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. Study design was created by Yehoshua, Pulicharam, Malone, and Armstrong. Pulicharam took the lead in data collection, along with Chancellor and Campbell, and data interpretation was performed by Chancellor, Vasavada, Malone, and Armstrong. The manuscript was written by Yehoshua and revised by Joshi and Yehoshua, with assistance from the other authors.

Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment.

PURPOSE: The purpose of this guideline amendment, herein referred to as the amendment, is to incorporate relevant newly published literature to better provide a clinical framework for the diagnosis and treatment of patients with non-neurogenic overactive bladder. MATERIALS AND METHODS: The primary source of evidence for this guideline is the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report searched PubMed, MEDLINE®, EMBASE and CINAHL for English language studies published from January 1966 to October 2008. The AUA conducted additional literature searches to capture populations and treatments not covered in detail by the AHRQ report and relevant articles published through December 2011. The review yielded 151 treatment articles after application of inclusion/exclusion criteria. An additional systematic review conducted in February 2014 identified 72 additional articles relevant to treatment and made up the basis for the 2014 amendment. RESULTS: The amendment focused on four topic areas: mirabegron, peripheral tibial nerve stimulation, sacral neuromodulation and BTX-A. The additional literature provided the basis for an update of current guideline statements as well as the incorporation of new guideline statements related to the overall management of adults with OAB symptoms. CONCLUSIONS: New evidence-based statements and expert opinion supplement the original guideline published in 2012, which provided guidance for the diagnosis and overall management of OAB in adults. An integrated presentation of the OAB guideline with the current amendments is available at www.auanet.org.

Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women.

OBJECTIVE: The objective of this study was to compare the backfill standard voiding trial (SVT) that relies on the assessment of voided volume to subjective patients' evaluation of their voiding based on the assessment of the force of stream (FOS) after an outpatient midurethral sling surgery. STUDY DESIGN: This double-blinded randomized trial included patients undergoing an outpatient midurethral sling surgery without any other concomitant surgery. Participants were randomized to either the SVT group or to the FOS group. The primary outcome was the rate of catheterization any time up to 6 weeks after surgery. Both groups underwent the same backfill voiding trial protocol postoperatively. Measurements of the voided amount, postvoid residual, and the response to the FOS visual analog scale were collected. The criteria for passing the voiding trial in the SVT group was voiding at least two-thirds of the instilled amount; while the criteria for passing the trial in the FOS group was assessment of FOS at least 50% of the baseline, regardless of the voided volume. Participants were interviewed preoperatively and 2-4 days, 7-9 days, and 6 weeks postoperatively. All postoperative interviews included assessments of pain, tolerance of physical activity, urinary FOS, as well as satisfaction with the surgery. Validated questionnaires (Incontinence Severity Index and Urinary Distress Inventory, short form) before the surgery and 6 weeks after were used to evaluate urinary symptoms. RESULTS: A total of 108 patients were enrolled and randomized, and 6-week follow-up data were available for 102 participants (FOS 50, SVT 52). The 2 groups were similar with respect to demographic characteristics and urinary symptoms. The incidence of catheterization was also similar between the groups (FOS 13 [26%], SVT 13 [25.5%]; P=.95). Amount voided had a moderate correlation with FOS assessment (Spearman rho 0.5; P<.001). There was no significant difference in mean catheter days, pain scores, Incontinence Severity Index, and Urinary Distress Inventory, short form scores between the 2 groups. Of the patients who were discharged home without a catheter in either group none required catheter reinsertion within 6 weeks after the surgery. CONCLUSION: Patient's subjective assessment of the urinary FOS correlated well with the measured voided amount and no difference in catheterization days was noted between the subjective and objective assessment of voiding. Thus subjective evaluation of the FOS is a reliable and safe method to use after outpatient midurethral surgery.

The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial.

We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6 months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014.

Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of non-neurogenic overactive bladder (OAB). MATERIALS AND METHODS: The primary source of evidence for this guideline is the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report searched PubMed, MEDLINE®, EMBASE and CINAHL for English-language studies published from January 1966 to October 2008. The AUA conducted additional literature searches to capture treatments not covered in detail by the AHRQ report and relevant articles published between October 2008 and December 2011. The review yielded an evidence base of 151 treatment articles after application of inclusion/exclusion criteria. 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). Additional treatment information is provided as Clinical Principles and Expert Opinions when insufficient evidence existed. RESULTS: The evidence-based guideline statements are provided for diagnosis and overall management of the adult with OAB symptoms as well as for various treatments. The panel identified first through third line treatments as well as non-FDA approved, rarely applicable and treatments that should not be offered. CONCLUSIONS: The evidence-based statements are provided for diagnosis and overall management of OAB, as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable.