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Consistent and durable improvements in quality of life with long-term onabotulinum toxin A treatment in patients with overactive bladder [Meeting Abstract]

Brucker, B; Nitti, V; Radomski, S; Gousse, A; Drake, M; Kaufmann, A; Magyar, A; Nicandro, J P; Ginsberg, D
Background: Overactive bladder (OAB) is a chronic condition that can cause significant burden and have a negative effect on patients' daily lives. There is a need to offer patients with OAB who are inadequately managed by an anticholingergic alternative therapies that are effective and improve quality of life (QOL) over the long-term. A long-term extension study involving patients with OAB and urinary incontinence (UI) who were inadequately managed by an anticholinergic (ACH) demonstrated that onabotulinum toxin A 100U provides consistent, long-term improvement of OAB symptoms. Here we evaluated the long-term effects of onabotulinum toxin A 100U on QOL in this extension study. Methods: Eligible patients who completed either of two phase 3 trials could enter a three-year extension study to receive onabotulinum toxin A treatment "as needed" for control of symptoms. Results are reported for up to six treatments. Assessments included change from baseline in Incontinence-QOL (I-QOL) total score and proportions of patients who achieved/exceeded the minimally important difference (MID) in I-QOL score (+10 points) after each treatment. Consistency of response over repeat treatments was evaluated by determining whether patients achieved >=MID after the first treatment, and then analyzing the proportion who achieved >=MID for all subsequent treatments. Results: Of 829 patients enrolled, discontinuations due to lack of efficacy/ adverse events were 5.7%/5.1%. After onabotulinum toxin A treatments 1-6, QOL improvements were consistently maintained at 2-3X MID across treatment cycles, with most patients achieving >=MID (range 65.2-76.1%). 72.9% of patients who achieved >=MID after treatment 1 maintained I-QOL improvements >=MID in all subsequent treatments. Over one-third (38.3%) of patients not achieving >=MID after treatment 1 achieved improvements >=MID in all subsequent treatments. No new safety signals were observed. Conclusions: Consistent improvements in OAB symptoms after long-term treatment with onabotulinum toxin A corresponded with durable QOL improvements, with no new safety signals. Patients with clinically meaningful QOL improvements after treatment 1 had similar improvements in subsequent treatments, while lack of response to treatment 1 did not preclude positive response(s) in subsequent treatments. These results help set treatment expectations of patients and clinicians for onabotulinum toxin A and support persistence of its use over the long-term. Additional analyses may further characterize the long-term effects of treatment with onabotulinum toxin A in patients with OAB inadequately managed by an ACH
EMBASE:617744064
ISSN: 1920-1214
CID: 2671482

Network meta-analysis to assess the treatment effect of onabotulinum toxin A, mirabegron, and anticholinergics vs. placebo for overactive bladder [Meeting Abstract]

Brucker, B; Drake, M; Ginsberg, D A; Chapple, C; McCool, R; Glanville, J; Fleetwood, K; James, D; Khalaf, K; Nitti, V W
Background: Pharmacotherapy is the second-line treatment for overactive bladder (OAB) after behavioral therapy, but there is a high discontinuation rate due to inadequate efficacy and/or intolerable side effects. Onabotulinum toxin A provides an additional treatment option for OAB in patients who are inadequately managed by an anticholinergic. This is the first comparison of the efficacy of all licensed doses of anticholinergics, mirabegron, and onabotulinum toxin A vs. placebo in adults with idiopathic overactive bladder using network meta-analysis (NMA) and meta-regression (NMR). Methods: Electronic databases, review documents, guidelines, and websites were searched for randomized blinded trials of >=2 weeks duration comparing any dose of onabotulinum toxin A, mirabegron, or oral/ transdermal anticholinergics with each other or placebo. Networks were developed for outcomes of interest based on studies of similar quality of study methods, confounding factors, common treatment arms, and outcomes measured. Bayesian random effects NMA (for the outcome of 100% reduction in urinary incontinence episodes [UIE]) and NMR (for outcomes on changes from baseline in UIE, urgency episodes, and micturition frequency) models were used to synthesize results at Week 12. Safety outcomes were not compared due to differences in adverse event profiles. Results: One hundred two trials were assessed. NMRs indicated that, after adjusting for differences in baseline severity between trials, all treatments were more efficacious than placebo. Patients who received onabotulinum toxin A (100U) had the greatest mean reductions in UIE (1.55 episodes/ day more than placebo [95% credible interval (CrI) 1.10, 2.01]), urgency (2.01 episodes/day more than placebo [CrI 1.48, 2.54]) and micturition frequency (1.37 episodes/day more than placebo [CrI 1.03, 1.70]). Onabotulinum toxin A patients also had the highest likelihood of achieving 100% UIE reduction (OR 4.30 vs. placebo [CrI: 3.03, 6.23]). Conclusions: This analysis suggests that onabotulinum toxin A 100U provides the greatest reduction in OAB symptoms and higher likelihood of being dry, relative to placebo, than all licensed doses of anticholinergics and mirabegron in the network. Additional studies should also evaluate the cost-effectiveness of onabotulinum toxin A vs. other OAB treatments
EMBASE:617744131
ISSN: 1920-1214
CID: 2671462

Best of the 2016 AUA Annual Meeting: Highlights From the 2016 American Urological Association Annual Meeting, May 6-10, 2016, San Diego, CA

Nickel, J Curtis; Gorin, Michael A; Alan W, Partin; Loeb, Stacy; Ellen, Shapiro; Chancellor, Michael B; Assimos, Dean G; Brawer, Michael K; Brucker, Benjamin M
PMCID:5102934
PMID: 27833468
ISSN: 1523-6161
CID: 2304542

Bladder Outlet Obstruction After Incontinence Surgery

Brucker, B M; Malacarne, D R
Stress urinary incontinence (SUI) is said to effect up to 80 % of all women who complain of some type of urinary leakage. As education about the diagnosis and treatment of SUI becomes more widespread, there is a need for understanding the efficacy and potential complications of the therapies used to treat this condition. It is widely accepted that the gold standard for treatment of SUI is mid-urethral sling (MUS). One significant complication of the MUS procedure is subsequent bladder outlet obstruction (BOO). We review the incidence and etiology of BOO following MUS and hope this document can be used as a guide for identifying patients who may be affected by postsurgical BOO. Additionally, we discuss modalities for achieving a timely and accurate diagnosis and highlight recent evidence regarding the various applications of urodynamic studies, when concerned for BOO. Lastly, various managements of this complication are discussed. This chapter serves as a comprehensive overview of BOO after incontinence procedures, highlighting the recent research contributions, which have enhanced our understanding of this potential complication when treating SUI
EMBASE:20160250630
ISSN: 1931-7212
CID: 2067252

HOW USEFUL ARE URODYNAMICS IN THE PREOPERATIVE ASSESSMENT OF WOMEN UNDER GOING SURGERY FOR PELVIC ORGAN PROLAPSE? [Meeting Abstract]

Glass, Dianne; Khan, Aqsa; Seo, Lauren; Brucker, Benjamin; Nitti, Victor
ISI:000369726700237
ISSN: 1520-6777
CID: 1989572

Guidelines of Guidelines: Urinary Incontinence

Syan, Raveen; Brucker, Benjamin M
OBJECTIVE: to review key guidelines on the management of urinary incontinence in order to guide clinical management in a practical way. MATERIALS AND METHODS: guidelines produced by the European Association of Urology (updated in 2014), the Canadian Urological Association (updated in 2012), the International Consultation on Incontinence (updated in 2012), and the National Collaborating Centre for Women's and Children's Health (updated in 2013) were examined and their recommendations compared. In addition, specialized guidelines produced by the collaboration between the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction on overactive bladder and the use of urodynamics were reviewed. The Appraisal of Guidelines for Research & Evaluation II (AGREE) Instrument was used to evaluate the quality of these guidelines. RESULTS: there is general agreement between the groups on the recommended initial workup and the use of conservative therapies for first line treatment, with limited role for imaging or invasive testing in the uncomplicated patient. These groups have greater variability in their recommendations for invasive procedures, however generally the mid-urethral sling is recommended for uncomplicated stress urinary incontinence, with different recommendations on the approach as well as the comparability to other treatments, such as the autologous fascial sling. CONCLUSION: this Guideline of Guidelines provides a summary of the salient similarities and differences between prominent groups on the management of urinary incontinence
PMID: 26033093
ISSN: 1464-410x
CID: 1615332

Neurourology of pregnancy

Chapter by: Ferrante, KL; Nitti, VW; Brucker, BM
in: Neurological Illness in Pregnancy: Principles and Practice by
pp. 258-268
ISBN: 9781118430903
CID: 2228902

Dramatic Enlargement of the Prostate due to Xanthogranulomatous Inflammation

Wollin, Daniel A; Brucker, Benjamin M
CASE: Xanthogranulomatous inflammation of the prostate is a rare condition that can cause lower urinary tract symptoms and may be mistaken for adenocarcinoma. It is often seen on prostate biopsy, but can usually be treated conservatively with temporary catheterization, alpha blockade, and allowing time for improvement. We present a case of a 78-year-old man found to have a 318 g prostate secondary to xanthogranulomatous inflammation. OUTCOME: After a negative MRI-guided biopsy to rule out malignancy, the patient was treated successfully with open suprapubic prostatectomy with significant improvement in voiding symptoms. CONCLUSION: This case highlights the ability of this clinical and pathologic entity to cause significant prostatic enlargement, how it is diagnosed, and the possible role of surgical therapy in its treatment.
PMID: 26663733
ISSN: 1757-5672
CID: 1877842

Management of Pelvic Organ Prolapse in the Elderly

Ohmann, E; Brucker, B M
Pelvic organ prolapse is a common condition for which age is a significant risk factor, making pelvic organ prolapse particularly prevalent in the elderly population. While not a life-threatening condition, pelvic organ prolapse can affect quality of life and impact daily activity with bothersome vaginal, urinary, bowel, and sexual symptoms. This review article addresses the management of symptomatic pelvic organ prolapse in the elderly population including evaluation, conservative and surgical approaches. Conservative management encompasses pelvic floor muscle training therapy and use of vaginal pessaries in addition to lifestyle modifications. Patients who have failed conservative management or desire definitive repair may be amenable to surgical intervention, comprising traditional and minimally invasive abdominal sacrocolpopexy, transvaginal repairs and obliterative procedures. Important pre-operative, intra-operative, and post-operative considerations unique to the elderly population are addressed as well
EMBASE:2015227682
ISSN: 2196-7865
CID: 1720482

Management of neurogenic lower urinary tract dysfunction in multiple sclerosis patients

Sadiq, Areeba; Brucker, Benjamin M
Multiple sclerosis (MS) can be a debilitating neurological condition that attributes significant morbidity to bladder dysfunction. Although many effective treatment options exist, symptomatic patients are often underdiagnosed and undertreated. The purpose of this article is to give an overview of the current literature including new screening tools to identify symptomatic patients and updates on treatment options including medications, botulinum toxin, and neuromodulation.
PMID: 26025495
ISSN: 1534-6285
CID: 1616482