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Overactive bladder (OAB) is associated with physical, emotional, and financial burden. After failed conservative measures, second-line therapy includes medications, such as antimuscarinics and beta-3 adrenergic receptor (β3AR) agonists. Antimuscarinics are most commonly prescribed but have systemic side effects that lead to poor compliance. β3AR agonists include mirabegron and vibegron. Mirabegron is a first-generation β3AR agonist that is effective for frequency, urgency urinary incontinence (UUI) and urgency, but has interactions with cytochrome P450 enzymes (CYPs) and cardiovascular sequelae. Vibegron is a second-generation β3AR agonist that is highly selective and does not interact with CYPs. It is effective for reducing UUI episodes and daily micturition number and has a favorable side effect profile.Clinical background, pharmacology, and clinical studies for vibegron.Vibegron is a welcomed addition to the OAB therapeutic landscape. This single dose, once daily option is effective, especially for patients with wet OAB, with a favorable side effect profile. Sub-analyses of patients ≥ 65 years have shown continued efficacy and safety. The few drug interactions are of benefit, especially for older patients with polypharmacy. As long-term data accrues, vibegron has the potential to drive the OAB therapeutic market.

Stress urinary incontinence (SUI) has been treated surgically with the midurethral sling but in recent years, this option has come under scrutiny and the risk–benefit balance continues to be reviewed. The low-risk alternative for women with uncomplicated SUI is the bulking agent, which aims to achieve continence through coaptation of the urethra. Two classes of bulking agents can be identified: those made from solid microparticles in an absorbable liquid or gel carrier (particulate agents) and those comprising a homogenous gel (non-particulates) that resists absorption. Polydimethylsiloxane®, carbon-coated zirconium oxide®, calcium hydroxyapatite® and polyacrylate polyalcohol copolymer® are currently marketed particulate agents. With the exception of calcium hydroxyapatite, the particles are non-degradable. Each agent achieves its long-term bulking effect through reactive changes around the persisting particles while the carrier volume is lost. Bulkamid® is a non-particulate agent with the bulking effect resulting from the volume of gel injected. The lasting network of fine fibers formed by the host tissue anchors the gel in situ. Foreign-body granulomas, erosion and migration/material extrusion and loss of bulk have been observed in connection with the particle-based products. Bulkamid may be mechanistically less liable to these events; however, there are minimal data directly comparing the two types of bulking agent. The question of durability is inevitable based on their differing modes of action.

Item does not contain fulltext CONTEXT: Several drugs are approved and available for the treatment of lower urinary tract symptoms (LUTS) in men and women. However, the vast majority of available data, upon which the approval and recommendation in guidelines are based, considered only the role of the monotherapies and did not evaluate possible combination therapies. OBJECTIVE: This systematic review analyzes the efficacy and adverse events of combination therapies for male and female LUTS. EVIDENCE ACQUISITION: A systematic literature search in the PubMed/Medline, Web of Science, and Cochrane databases was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement to identify clinical trials, randomized controlled trials, meta-analyses, and guidelines on male and female LUTS combination therapy published from March 2012 to December 2017 for men (in order to update a previous men-focused work) and from January 1988 to December 2017 for women. A total of 58 papers were identified. EVIDENCE SYNTHESIS: The most studied combination therapy for the treatment of male LUTS is the alpha1-adrenoceptor antagonist/5alpha-reductase inhibitor combination. This combination seems to be more efficacious in terms of several outcome variables, in particular in men who have moderate-to-severe LUTS and are at risk of disease progression. Also in terms of nocturia improvements, this combination is significantly more effective than the monotherapy. The other often studied combination treatment, in both male and female patients with LUTS, was the combination of antimuscarinics (in particular solifenacin) and mirabegron. This combination seems to be more effective in comparison with the monotherapies with respect to urinary incontinence and urgency urinary incontinence episodes and several other objective and subjective parameters, without relevant increase of adverse events. The combination of hormone therapy and antimuscarinics in women with LUTS does not seem to be useful. CONCLUSIONS: For the treatment of LUTS in men and women, combination therapy appears to be a promising option to optimize the efficacy of the available drugs for those who do not experience sufficient benefit with monotherapy. This add-on scenario offers the possibility to have a more tailored approach to the management of LUTS, always seeking the optimal balance between efficacy and tolerability for a given patient. PATIENT SUMMARY: Some combination of drugs may offer advantages over monotherapies for the treatment of voiding and storage complaints in men and women.

Stress urinary incontinence is a common problem experienced by many women that can have a significant negative impact on the quality of life of those who suffer from the condition and potentially those friends and family members whose lives and activities may also be limited.A comprehensive search of the literature was performed by ECRI Institute. This search included articles published between January 2005 and December 2015 with an updated abstract search conducted through September 2016. 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) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions.The AUA (American Urological Association) and SUFU (Society of Urodynamics, Female Pelvic MedicineUrogenital Reconstruction) have formulated an evidence-based guideline focused on the surgical treatment of female stress urinary incontinence in both index and non-index patients.The surgical options for the treatment of stress urinary incontinence continue to evolve; as such, this guideline and the associated algorithm aim to outline the currently available treatment techniques as well as the data associated with each treatment. Indeed, the Panel recognizes that this guideline will require continued literature review and updating as further knowledge regarding current and future options continues to grow.

Overactive bladder affects 12% to 17% of the general population and almost a third experience urinary incontinence, which may severely impact health related quality of life. Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects, leading to a high discontinuation rate. We report the results of the first large (557 patients), phase 3, placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics.Eligible patients with overactive bladder, 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were randomized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo. Co-primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12. Secondary end points included other overactive bladder symptoms and health related quality of life. Adverse events were assessed.OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo (-2.65 vs -0.87, p0.001) and 22.9% vs 6.5% of patients became completely continent. A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale (60.8% vs 29.2%, p0.001). All other overactive bladder symptoms improved vs placebo (p ≤ 0.05). OnabotulinumtoxinA improved patient health related quality of life across multiple measures (p0.001). Uncomplicated urinary tract infection was the most common adverse event. A 5.4% rate of urinary retention was observed.OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated.

PURPOSE: To provide a clinical framework for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. MATERIALS AND METHODS: A systematic review of the literature using the MEDLINE® database (search dates 1/1/83–7/22/09) was conducted to identify peer reviewed publications relevant to the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. Insufficient evidence-based data were retrieved regarding diagnosis and, therefore, this portion of the Guideline is based on Clinical Principles and Expert Opinion statements. The review yielded an evidence base of 86 treatment articles after application of inclusion/exclusion criteria. These publications were used to create the majority of the treatment portion of the Guideline. 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 Opinion when insufficient evidence existed. See text and algorithm for definitions, and detailed diagnostic management, and treatment frameworks. RESULTS: The evidence-based guideline statements are provided for diagnosis and overall management of interstitial cystitis/bladder pain syndrome as well as for various treatments. The panel identified first through sixth line treatments as well as developed guideline statements on treatments that should not be offered. CONCLUSIONS: Interstitial cystitis/bladder pain syndrome is best identified and managed through use of a logical algorithm such as is presented in this Guideline. In the algorithm the panel identifies an overall management strategy for the interstitial cystitis/bladder pain syndrome patient. Diagnosis and treatment methodologies can be expected to change as the evidence base grows in the future.

The Nocturia Think Tank (TT) met during the 2010 meeting of the International Consultation on Incontinence-Research Society to discuss present knowledge and future directions in care and research of this prominent component of the spectrum of lower urinary tract symptoms. Questions raised included whether nocturia should be re-defined as a function of its bother, effects on quality of life, and economic impact upon society. At issue is the need to delineate the determinants of successful nocturia management. The multifactorial nature of nocturia requires that progress in its treatment will be dependent upon the cooperative investigation on the part of urologists, urogynecologists, geriatricians, epidemiologists, medical economists and pharma. Areas for future avenues of research were outlined at the conclusion of the meeting. Wiley-Liss, Inc.

OBJECTIVE To assess the 24-h efficacy of tolterodine extended-release (ER) in patients with overactive bladder (OAB) and urgency urinary incontinence (UUI). PATIENTS AND METHODS We conducted a post hoc analysis of a 12-week, placebo-controlled trial of tolterodine-ER in patients with frequency (≥8 voids/24 h) and UUI (≥5 episodes/week) for ≥ 6 months. Seven-day bladder diaries were used to record diary endpoints; 24-h diary data were stratified by 6-h periods beginning at midnight. RESULTS Compared with placebo (508 patients), tolterodine-ER (507 patients) significantly and consistently increased volume voided per void and reduced UUI episodes and micturition frequency during each interval. CONCLUSIONS These results indicate that tolterodine-ER maintained clinical efficacy over 24 h and should be effective for OAB symptoms without regard to whether symptoms occur during the day or at night.

Cerebrovascular accidents and intracranial tumors are common pathologic processes that alter higher cortical function and normal urologic function. Therefore, these disease entities and their subsequent urologic consequences are clinically important to urologists. Approximately 1 million Cerebrovascular accident occur in the United States each year. With the population as a whole increasing in age, the cumulative number of post-CVA patients is expected to greatly increase in the future. There are two broad categories of Cerebrovascular accidents: occlusive lesions, either embolic or thrombotic, and hemorrhagic lesions, from trauma or vascular malformation. Sustained intracranial pressure greater than 200 mmH2O can result in life-threatening herniation of the brain. Urinary retention may be the first urologic event to occur after a Cerebrovascular accidents.

To present final efficacy/safety results from a prospective, long-term extension trial of onabotulinumtoxinA for urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO); patients received treatment for up to 4 years.Patients who completed a 52-week, phase III trial of onabotulinumtoxinA for NDO were eligible to enter a 3-year, multicenter, open-label extension study of intradetrusor onabotulinumtoxinA (200U or 300U). Patients were treated "as needed" based on their request and fulfillment of prespecified qualification criteria (≥12 weeks since previous treatment and a UI episode threshold). Assessments included change from study baseline in UI episodes/day (primary efficacy measure), volume/void, and Incontinence Quality of Life (I-QOL) total score (week 6); duration of effect; adverse events (AEs); and initiation of de novo clean intermittent catheterization (CIC). Data are presented for up to six treatments.OnabotulinumtoxinA 200U consistently reduced UI episodes/day; reductions from baseline ranged from -3.2 to -4.1 across six treatments. Volume/void consistently increased, nearly doubling after treatment. I-QOL improvements were consistently greater than twice the minimally important difference (+11 points). Overall median duration of effect was 9.0 months (200U). Results were similar for onabotulinumtoxinA 300U. Most common AEs were urinary tract infections and urinary retention. De novo CIC rates were 29.5, 3.4, and 6.0% (200U), and 43.0, 15.0, and 4.8% (300U) for treatments 1-3, respectively; de novo CIC rates were 0% for treatments 4-6.OnabotulinumtoxinA treatments consistently improve UI, volume/void, and QOL in patients with UI due to NDO in this 4-year study, with no new safety signals. Neurourol. Urodynam. 36:368-375, 2017. © 2015 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.