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      A review of prospective Clinical Trials for neurogenic bladder: Pharmaceuticals

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          Abstract

          Introduction

          The neurogenic urinary bladder is defined as a dysfunctional bladder associated with a known neurological injury. We review the data from good quality clinical trials looking at drug therapy for the neurogenic bladder.

          Materials and methods

          In order to identify as many prospective trials as possible, we performed Internet searches, using the same search string: Urinary Bladder, neurogenic (MESH). In each case, the search was limited to clinical trial, prospective trial, subjects were human and the language was English. There was no year limit for our search. The next step was duplicate removal, which led to a final number of 580 papers. We defined clear inclusion criteria for the papers.

          Results

          A total of 82 full text papers were reviewed and analyzed according to the previously mentioned algorithm. The oldest two prospective clinical trials date back to 1976, with an obvious increase in number of trials each year, reaching more than five trials per year after 2001, which demonstrates increased interest toward the subject. The total number of patients included in the trials is 3904, 888 of which are children. The male: female ratio is close to 1, although there were 9 studies where no information regarding the sex of the patients was available.

          Conclusions

          Our analysis stresses the acute need for good quality trials looking at the drugs used for the management of the patients with neurogenic bladders, with adequate statistical power to support the data they present.

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          Most cited references19

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          A systematic review and meta-analysis of randomized controlled trials with antimuscarinic drugs for overactive bladder.

          Anticholinergic drugs are commonly used in patients with overactive bladder (OAB) who do not achieve symptom relief and quality of life improvement with conservative management. Several drugs, with different doses, formulations, and routes of administration are currently available, making the choice quite difficult. To evaluate efficacy and safety of different doses, formulations, and route of administration of the available anticholinergic drugs. A systematic review of the literature was performed in August 2007 using Medline, Embase, and Web of Science. Efficacy (micturitions per 24h, volume voided per micturition, urgency urinary incontinence episodes per 24h, incontinence episodes per 24h) and safety (mainly, adverse events and withdrawal rates) end points were evaluated in the randomized control trials (RCTs) assessing the role of anticholinergic drugs in non-neurogenic OAB. Meta-analysis of RCTs was conducted using the Review Manager software 4.2 (Cochrane Collaboration). Our systematic search identified 50 RCTs and three pooled analyses. Tolterodine immediate release (IR) had a more favorable profile of adverse events than oxybutynin IR. Regarding different dosages of IR formulations, dose escalation might yield some limited improvements in the efficacy but at the cost of significant increase in the rate of adverse events. In the comparisons between IR and extended-release (ER) formulations, the latter showed some advantages, both in terms of efficacy and safety. With regard to the route of administration, use if a transdermal route of administration does not provide significant advantage over an oral one. Many of the available RCTs have good methodological quality. ER formulations should be preferred to the IR ones. With regard to IR formulations, dose escalation might yield some improvements in the efficacy with significant increase in the AE. More clinical studies are needed to indicate which of the drugs should be used as first-, second-, or third-line treatment.
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            Contemporary management of lower urinary tract disease with botulinum toxin A: a systematic review of botox (onabotulinumtoxinA) and dysport (abobotulinumtoxinA).

            The use of botulinum toxin A (BoNTA) in the treatment of lower urinary tract dysfunction has expanded in recent years and the off-licence usage list includes neurogenic detrusor overactivity (NDO), idiopathic detrusor overactivity (IDO), painful bladder syndrome (PBS), and lower urinary tract symptoms resulting from bladder outflow obstruction (BOO) or detrusor sphincter dyssynergia (DSD). There are two commonly used preparations of BoNTA: Botox (onabotulinumtoxinA) and Dysport (abobotulinumtoxinA). To compare the reported outcomes of onabotulinumtoxinA and abobotulinumtoxinA in the treatment of NDO, IDO, PBS, DSD, and BOO for adults and children. We performed a systematic review of the published literature on PubMed, Scopus, and Embase in the English language reporting on outcomes of both BoNTA preparations. Review articles and series with <10 cases were excluded. The articles were graded for level of evidence and conclusions drawn separately for data with higher-level evidence. There is high-level evidence for the use of onabotulinumtoxinA and abobotulinumtoxinA in adults with NDO but only for abobotulinumtoxinA in children with NDO. Only onabotulinumtoxinA has level 1 evidence supporting its use in IDO, BOO, DSD, and PBS/interstitial cystitis. We identified good-quality studies that evaluated onabotulinumtoxinA for all the indications described above in adults; such was not the case with abobotulinumtoxinA. Although this does not imply that onabotulinumtoxinA is more effective than abobotulinumtoxinA, it should be a consideration when counselling patients on the use of botulinum toxin in urologic applications. The two preparations should not be used interchangeably, either in terms of predicting outcome or in determining doses to be used. Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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              Bladder management for adults with spinal cord injury: a clinical practice guideline for health-care providers.

              (2005)
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                Author and article information

                Journal
                Cent European J Urol
                Cent European J Urol
                CEJU
                Central European Journal of Urology
                Polish Urological Association
                2080-4806
                2080-4873
                18 August 2014
                2014
                : 67
                : 3
                : 264-269
                Affiliations
                [1 ]Department of Urology, Carol Davila University of Medicine, Romania
                [2 ]Instituto Nacional de Rehabilitacion Psicofisica del Sur. Mar del Plata, Argentina
                [3 ]Stanford University & Staff Physician VA Palo Alto Health Care System, Department of Urology, Palo Alto, California, USA
                Author notes
                Correspondence Cristian Persu, Carol Davila University of Medicine, Department of Urology, Dr Cretestilor Nr 3K, Sector 4, 042183 Bucharest, Romania. phone: +40 722 302 225. cpersu@ 123456clicknet.ro
                Article
                00337
                10.5173/ceju.2014.03.art11
                4165668
                bc53ff1b-d49e-4f1f-b6ea-a2a75098461b
                Copyright by Polish Urological Association

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License, permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 17 November 2013
                : 11 January 2014
                : 31 May 2014
                Categories
                Review Paper

                neurogenic bladder,clinical trial,drug therapy,antimuscarinics,botulinum toxin

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