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      Is there any Relationship Between Bladder Trabeculation and Efficacy and Safety of Intravesical Botulinum Toxin A Injection in Refractory Idiopathic Overactive Bladder Women?

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          Abstract

          Background:

          Intradetrusor injection of botulinum toxin A (BTX-A) might serve as a minimally invasive substitute in patients with refractory idiopathic overactive bladder (RIOAB). The aim of this study was to evaluate the clinical outcomes related to two different doses of abo-BTX-A (AboBTX-A) in patients with RIOAB.

          Materials and Methods:

          This prospective clinical trial was performed on 55 women with RIOAB. After determination of trabeculation grade, 300 (no or mild) or 500 (moderate or severe) unit of AboBTX-A (Dysport) was intravesicaly injected. Before 1, 3, and 6 months after intervention, lower urinary tract symptoms during 24 h were recorded.

          Results:

          Of the study population, 62% had severe bladder trabeculation. The mean duration of overactive bladder (OAB) was 1.76 versus 5.85 years, for no or mild versus severe trabeculation, respectively. After injections of 300- and 500-unit dosage, there were 19% and 26% early complications such as urinary retention. There was a statistically significant difference between the two groups in OAB score after 1 month ( P < 0.001) and duration of OAB symptoms, over three follow-up times ( P < 0.001). The mean preinjection OAB scores between patients with and without recurrence were statistically significant (29.36 vs. 25.07; P < 0.03). Urinary tract infection as a late complication was distinguished in four patients.

          Conclusion:

          In RIOAB, by adjusted dosage of AboBTX-A related to the grade of bladder trabeculation, in addition to maintain efficacy, consequent complications might not be affected by dosage and the drug dosage could be increased to nearly 60% with less concern associated to complication

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          Most cited references35

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          The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society.

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            Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs? Preliminary results.

            We evaluated the efficacy of botulinum-A toxin injections into the detrusor muscle in patients with spinal cord injury, detrusor hyperreflexia and urge incontinence resistant to anticholinergic drugs. The purpose of treatment was to suppress incontinence episodes and increase functional bladder capacity. Included in our prospective nonrandomized study done at 2 clinics were 31 patients with traumatic spinal cord injury who emptied the bladder by intermittent self-catheterization. These patients had severe detrusor hyperreflexia and incontinence despite a high dose of anticholinergic medication. Pretreatment evaluation included a clinical examination and complete urodynamic investigation. Under cystoscopic control a total of 200 to 300 units of botulinum-A toxin were injected into the detrusor muscle at 20 to 30 sites (10 units per ml. per site), sparing the trigone. Clinical and urodynamic followup was planned for 6, 16 and 36 weeks after treatment. Patients were asked to decrease their intake of anticholinergic drugs during week 1 after treatment. Of the 21 patients 19 underwent a complete examination 6 weeks after the botulinum-A toxin injections, and 11 at 16 and 36 weeks. At the 6-week followup complete continence was restored in 17 of 19 cases in which anticholinergic medication was markedly decreased or withdrawn. Less satisfactory results in 2 cases were associated with an insufficient dose of 200 units botulinum-A toxin. After the injections overall mean reflex volume and mean maximum cystometric bladder capacity plus or minus standard deviation significantly increased from 215.8 +/- 90.4 ml. to 415.7 +/- 211.1 (p <0.016) and 296.3 +/- 145.2 to 480.5 +/- 134.1 (p <0.016), respectively. There was also a significant decrease after treatment in mean maximum detrusor voiding pressure from 65.6 +/- 29.2 cm. water to 35 +/- 32. 1 (p <0.016). Mean post-void residual urine volume catheterized at the end of the urodynamic examination increased significantly from a mean of 261.8 +/- 241.3 ml. to 490.5 +/- 204.8 (p <0.016). Moreover, autonomic dysreflexia associated with bladder emptying that manifested as a hypertensive crisis during voiding disappeared after treatment in the 3 patients with tetraplegia. Satisfaction was high in all successfully treated patients and no side effects were observed. Ongoing improvement in urodynamic parameters and incontinence was already present in all patients reevaluated at 16 and 36 weeks. Botulinum-A toxin injections into the detrusor seem to be a safe and valuable therapeutic option in spinal cord injured patients with incontinence resistant to anticholinergic medication who perform clean intermittent self-catheterization. Successfully treated patients become continent again and may withdraw from or markedly decrease anticholinergic drug intake. A dose of 300 units botulinum-A toxin seems to be needed to counteract an overactive detrusor. The duration of bladder paresis induced by the toxin is at least 9 months, when repeat injections are required.
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              Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial.

              Treatment options for patients with overactive bladder refractory to anticholinergics are limited. We assessed the dose response across a range of doses of onabotulinumtoxinA (BOTOX®) in patients with idiopathic overactive bladder and urinary urgency incontinence whose symptoms were not adequately managed with anticholinergics. In a phase 2, multicenter, randomized, double-blind study, 313 patients with idiopathic overactive bladder and urinary urgency incontinence experiencing 8 or more urinary urgency incontinence episodes a week and 8 or more micturitions daily at baseline received 50, 100, 150, 200 or 300 U intradetrusor onabotulinumtoxinA, or placebo. Symptoms were recorded using a 7-day bladder diary. The primary efficacy variable was weekly urinary urgency incontinence episodes and the primary end point was week 12. Demographics and baseline characteristics were balanced across the treatment groups. Durable efficacy was observed for all onabotulinumtoxinA dose groups of 100 U or greater for primary and secondary efficacy measures, including the proportion of incontinence-free patients. When the dose response curves were analyzed, doses greater than 150 U contributed minimal additional or clinically relevant improvement in symptoms. This finding was also reflected in health related quality of life assessments. Dose dependent changes in post-void residual urine volume were observed and the use of clean intermittent catheterization was also dose dependent. The only adverse events significantly greater with onabotulinumtoxinA than with placebo were urinary tract infection and urinary retention. OnabotulinumtoxinA at doses of 100 U or greater demonstrated durable efficacy in the management of idiopathic overactive bladder and urinary urgency incontinence. A dose of 100 U may be the dose that appropriately balances the symptom benefits with the post-void residual urine volume related safety profile. Copyright © 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Adv Biomed Res
                Adv Biomed Res
                ABR
                Advanced Biomedical Research
                Medknow Publications & Media Pvt Ltd (India )
                2277-9175
                2017
                31 August 2017
                : 6
                : 113
                Affiliations
                [1] From the Isfahan Kidney Transplantation Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
                [1 ] Department of Urology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
                Author notes
                Address for correspondence: Dr. Farshid Alizadeh, Isfahan Kidney Transplantation Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. E-mail: f-alizadeh@ 123456med.mui.ac.ir
                Article
                ABR-6-113
                10.4103/abr.abr_393_14
                5590396
                3e41ccab-958c-4657-a716-6c693fe7ef53
                Copyright: © 2017 Advanced Biomedical Research

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

                History
                : August 2014
                : July 2016
                Categories
                Original Article

                Molecular medicine
                bladder,botulinum toxin a,idiopathic,trabeculation,women
                Molecular medicine
                bladder, botulinum toxin a, idiopathic, trabeculation, women

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