Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial.

PURPOSE: We conducted a 2-stage, multicenter, double-blind, randomized phase II clinical trial of 100 and 300 unit doses of onabotulinum toxin A to treat the lower urinary tract symptoms of benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years old or older with clinically diagnosed benign prostatic hyperplasia, American Urological Association symptom index 8 or greater, maximum urinary flow rate less than 15 ml per second, voided volume 125 ml or greater, and post-void residual 350 ml or less were randomized to prostatic transrectal injection of 100 or 300 units of onabotulinum toxin A. The primary outcome was at least 30% improvement from baseline to 3 months in American Urological Association symptom index and/or maximum urinary flow rate and safety. The men were followed for 12 months. RESULTS: A total of 134 men were randomized and treated (68 with 100 units, 66 with 300 units), with 131 assessed at 3 months and 108 assessed at 12 months. Each dose met the 3-month primary outcome criteria. In the 100 unit arm the mean baseline American Urological Association symptom index of 18.8 decreased by 7.1 and 6.9 at 3 and 12 months, respectively. In the 300 unit arm the baseline of 19.5 decreased by 8.9 and 7.1, respectively. In the 100 unit arm the mean baseline maximum urinary flow rate of 10.0 ml per second increased by 2.5 and 2.2, respectively, and in the 300 unit arm the baseline of 9.6 increased by 2.6 and 2.3, respectively. CONCLUSIONS: The intraprostatic injection of 100 or 300 units of onabotulinum toxin A passed predetermined criteria for treatment efficacy and safety, and a randomized trial with either dose is warranted. The 100 unit dose may be preferable due to similar efficacy with reduced costs and adverse effects.

Update on AUA guideline on the management of benign prostatic hyperplasia.

PURPOSE: To revise the 2003 version of the American Urological Association's (AUA) Guideline on the management of benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: From MEDLINE® searches of English language publications (January 1999 through February 2008) using relevant MeSH terms, articles concerning the management of the index patient, a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms (LUTS) were identified. Qualitative analysis of the evidence was performed. Selected studies were stratified by design, comparator, follow-up interval, and intensity of intervention, and meta-analyses (quantitative synthesis) of outcomes of randomized controlled trials were planned. Guideline statements were drafted by an appointed expert Panel based on the evidence. RESULTS: The studies varied as to patient selection; randomization; blinding mechanism; run-in periods; patient demographics, comorbidities, prostate characteristics and symptoms; drug doses; other intervention characteristics; comparators; rigor and intervals of follow-up; trial duration and timing; suspected lack of applicability to current US practice; and techniques of outcomes measurement. These variations affected the quality of the evidence reviewed making formal meta-analysis impractical or futile. Instead, the Panel and extractors reviewed the data in a systematic fashion and without statistical rigor. Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases. Guideline statements concerning pharmacotherapies, watchful waiting, surgical options and minimally invasive procedures were either updated or newly drafted, peer reviewed and approved by AUA Board of Directors. CONCLUSIONS: New pharmacotherapies and technologies have emerged which have impacted treatment algorithms. The management of LUTS/BPH continues to evolve.

Benign prostate hyperplasia: a review of the year's progress from bench to clinic.

PURPOSE OF REVIEW: Therapeutic tools for classic benign prostate hyperplasia (BPH) have focused on the dynamic component of obstruction and/or elimination of the static component via surgical or pharmaceutical therapies. Unfortunately, an exact cause for this disease process has not been identified, but additional insight has been achieved. This article presents an update of the BPH literature with a special focus on basic science or translational studies concerned with the cause of clinically significant BPH with lower urinary tract symptoms (LUTS). RECENT FINDINGS: Investigators are exploring connections between BPH with clinically significant LUTS, the metabolic syndrome, inflammation, alterations in cell signaling, and genetics which in turn has provided additional information concerning the pathogenesis, medical therapies as well as surgical therapies. SUMMARY: BPH is a chronic, progressive disease with important care implications and financial risks to the healthcare system. Continued improvements in length of life will demand that we unlock the cause of LUTS secondary to BPH with the goal of prevention as the ideal therapy. Studies reported in the last year contributed to our understanding of the disease process and provide insight for additional studies.

Minimally invasive therapy of lower urinary tract symptoms.

The establishment of guidelines, pharmacologic therapies, improved understanding of lower urinary tract symptoms (LUTS) versus benign prostate hyperplasia (BPH), respect for patient-centered goals, and improved discrimination of the patient with occult prostate cancer have empowered change in the management of LUTS. These developments have allowed urologists to recognize the limitations of transurethral prostatectomy as the gold standard and search for "ideal therapies" to provide treatments with an improved relief of symptoms, decreased complication rate and cost, to correct BPH-associated morbidities and prevent future morbidities. Prognostic parameters and their ability to predict progression may be important in the future of LUTS management and selection of therapy.

Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial.

PURPOSE: The primary responsibility of institutional review boards is to protect human research subjects and, therefore, ensure that studies are performed in accordance with a standard set of ethical principles. A number of groups have compared the responses of institutional review boards in multicenter clinical trials involving medical therapies. To our knowledge no such studies have been performed to date of trials investigating surgical intervention. We investigated the consistency of the recommendations issued by various institutional review boards in the Minimally Invasive Surgical Therapies study for benign prostatic hyperplasia, a multicenter trial with a uniform consent and study protocol. MATERIALS AND METHODS: We obtained the institutional review board response from 6 of the 7 participating institutions after initial submission of the Minimally Invasive Surgical Therapies study protocol and classified the responses. We then redistributed the approved protocols to an institutional review board at another participating institution and analyzed that review of these protocols. RESULTS: We found that the number and type of responses required for institutional review board approval of an identical study protocol varied significantly among participating institutions. We also found that institutional review board responses were inconsistent in the second review, although all protocols were ultimately approved. CONCLUSIONS: The current system of local institutional review board review in the context of a multicenter surgical trial is inefficient in the review process and may not provide expertise for overseeing surgical trials. Based on these results a central surgical institutional review board may be needed to improve the ethical review process in multicenter trials.

Use of consumer health vocabularies in online physician directory to improve physician search.

There is a language gap between health care providers and consumers, which is a substantial barrier to access health information for consumers. Unlike doctors who tend to use formal medical terms to describe health-related concepts, consumers use more simple words or "everyday language" to express those concepts. We compared the health care emphasis terms entered by providers on the HealthLink online physician directory with the search terms entered by consumers in the year of 2006 to sort out the different ways between professional and lay expressions to describe health-related concepts. By adding more consumer-oriented terms selected from HealthLink log files and UMLS Metathesaurus to the current system, we are developing our own consumer health vocabulary to improve physician search.

Management of ileostomy trauma produced by a dog bite in a patient with thoracic paraplegia.

Urologic trauma produced by dog bites is uncommon. Several previous single reports and small case series have described the treatment of dog bite-induced injuries to the external genitalia. In this report, we describe our treatment of a patient with thoracic paraplegia and an ileal conduit who had extensive trauma to his ileostomy as a result of a bite by the family dog. To our knowledge, the current case is the first report of dog bite-induced ileostomy trauma.

Prostatitis: the cost of disease and therapies to patients and society.

Prostatitis is an elusive clinical phenomenon that has become a synonymous term to describe a plethora of lower urinary tract symptoms in men including urinary problems, sexual dysfunction, and pelvic pain. Although symptom presentation has been standardized, an accurate, consistent clinical diagnosis continues to be elusive at best. As a result, recurrence is common, quality of life is compromised, and the patients and society feel the cost of this disease.

Changes in medicare reimbursement: impact on therapy for benign prostatic hyperplasia.

Medicare spending accounts for 17% of all health spending and therefore exerts a significant influence on health care spending policies. Medicare policies such as Diagnostic Related Groups and the Resource Based Relative Value System have resulted in profound changes in health care delivery in the United States. These resource-allocation methods are one of the major sources of controversies between managers, doctors, politicians, and social scientists. Financial disincentives associated with these resource-allocation policies have effectively rationed select therapies, particularly transurethral resection of the prostate (TURP). As a consequence, TURP, once the second most common surgical procedure billed to Medicare and comprising 38% of major surgical procedures performed by urologists, is increasingly challenged by medical therapy and minimally invasive surgical therapies that may be associated with lower efficacy and durability. This article examines the history of Medicare policies and their influence on TURP.