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3703-3712-Flavoxate in the Symptomatic Treatment of Overactive Bladder: a Meta-Analysis

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3703-3712-Flavoxate in the Symptomatic Treatment of Overactive Bladder: a Meta-Analysis Eur opean Rev iew for Med ical and Pharmacol ogical Sci ences 2016; 20: 3703-3712 Flavoxate in the symptomatic treatment of overactive bladder: a meta-analysis P. SWEENEY 1, S. MUTAMBIRWA 2, N. VAN AN 3, J.B. SHARMA 4, P. VANAMAIL 5 1Urology Department, Mercy University Hospital, Grenville Place, Cork, Ireland 2Department of Urology, Dr George Mukhari Academic Hospital/University of Limpopo, Limpopo, South Africa 3Urology Department, Binh Dan Hospital, Ho Chi Minh City, Vietnam 4Department of Obstetrics and Gynaecology AIIMS, New Delhi, India 5Bio Statistics, Department of Obstetrics and Gynaecology AIIMS, New Delhi, India Abstract. – OBJECTIVE : Overactive bladder Key Words: is a syndrome of urinary frequency and ur - Clinical trial, Meta-analysis, Flavoxate, Placebo, gency, with or without urge incontinence, in the Over active bladder, Detrusor overactivity, Efficacy, absence of local pathological factors. Since Side effects, Urinary Incontinence, Mixed Inconti - multiple causes are responsible for OAB, it re - nence, Nocturia, Unpleasant urination, Stranguria. quires proper diagnosis and comprehensive management. For decades, flavoxate is a glob - ally used and accepted molecule by the urolo - gists and the general physicians for the symp - tomatic treatment of OAB. In spite of its exten - sive use in OAB, a meta-analysis of the avail - Introduction able publications for efficacy, safety and tolera - bility of flavoxate has not been conducted. This The International Continence Society defines paper evaluates the strength of evidence of overactive bladder (OAB) as a syndrome of uri - clinical effectiveness of safety and tolerability nary frequency and urgency, with or without urge of flavoxate in the symptomatic treatment of incontinence, which appears in the absence of lo - OAB. cal pathological factors 1. Incontinence, a bother - METHODS: Review articles, original studies some symptom of OAB, increases with age 2. and case reports on MEDLINE, the Cochrane Library, Google Scholar, Scirus, internal repos - Neurologic impairment, immobility, female gen - itory, etc. were searched using the keyword der, and history of hysterectomy are the risk fac - “flavoxate”. For the primary outcome, the com - tors for the development of OAB . Commonly parative data of flavoxate versus comparator urge incontinence coexists with stress inconti - was extracted for following parameters – over - nence , especially in women. all efficacy and its side effect profile. Similarly Detrusor overactivity is a predominant cause as for secondary outcome, data were extracted for the OAB . It may be either idiopathic or neu - for flavoxate per se for overall efficacy, fre - rogenic in origin. The common symptoms com - quency, urinary incontinence, mixed inconti - nence, nocturia, unpleasant urination, stran - plained by OAB patients are urinary urge incon - guria and its side effect profile and were ana - tinence, involuntary leakage accompanied by or lyzed using Comprehensive Meta-Analysis immediately preceded by urgency 3,4 . (CMA) software version 2.0. Prompt diagnosis is crucial for the comprehen - RESULTS: In the current meta-analysis, 43 rel - sive management of OAB . Treatment is instituted evant published studies were considered which according to the type of incontinence and in - clearly demonstrated that flavoxate had im - cludes behavioural training (prompted voiding, proved clinical efficacy than placebo, emeproni - um, propantheline, and phenazopyridine. bladder training, pelvic muscle rehabilitation, CONCLUSIONS: Amongst all the interventions pelvic floor exercises), transcutaneous electrical studied, flavoxate was effective and well-tolerat - nerve stimulation, catheterization, use of ab - ed, with almost negligible side effects, making it sorbent pads or pharmacologic or surgical treat - worthy of consideration for the treatment of OAB. ment 5. Corresponding Author: P. Vanamail, MD; e-mail: [email protected] 3703 P. Sweeney, S. Mutambirwa, N. Van An, J.B. Sharma, P. Vanamail On the other hand, the pharmacological inter - The secondary outcome was to assess the ef - ventions for the treatment of OAB should focus on fect of flavoxate per se on overall efficacy, fre - patient benefit and therefore patient perceived out - quency, urinary incontinence, mixed inconti - comes, rather than simple symptom resolution nence, nocturia, unpleasant urination, stranguria , alone, should be taken into account 5. Moreover, the as well as its side effect profile in the sympto - efficacy of OAB therapy needs to be balanced matic treatment of OAB. against tolerability, since a low incidence of ad - verse events (AEs) improves compliance with treatment. This balance between efficacy and toler - Data Analysis ability should provide palpable benefits from pa - Meta-analysis was performed using Compre - tient’s perspective, and promote therapy persis - hensive Meta-Analysis (CMA) software version tence. Unfortunately, many older agents have mod - 2.0 procured from Biostat, Inc. USA. Mantel est clinical efficacy and are associated with unfa - Haenszel risk ratio (MH risk ratio) was accessed vorable side effects, leading to poor persistence . for ‘flavoxate versus comparator’ (i.e., placebo, Among various pharmacological interventions oxybutynin, phenazopyridine, emepronium, for the treatment of OAB, flavoxate has been propantheline) and event rate for flavoxate per se widely used and accepted among the urologists in the symptomatic treatment of OAB. Hetero - and the general physicians for decades globally 6. geneity between studies was accessed using Q We performed a meta-analysis on flavoxate to in - value and I square statistics using both fixed and vestigate, based on available evidence, its effica - random effect model. cy, side effects profile , and effects on frequency, urinary incontinence, mixed incontinence, noc - turia, unpleasant urination and stranguria (de - Results fined as slow and painful urination or burning) . The databases searches yielded 86 publica - tions pooled from PubMed, Google Scholar, Methods Medline , Cochrane Database and internal repos - itory 7-49 . According to our inclusion and exclu - Database Search and Data Extraction sion criteria , 43 relevant studies were identified The search was performed between June and (Figure 1) . August 2015 by using the keyword “ flavoxate ” on various search engines like Google Scholar, Medline, Cochrane Database, and personal col - Primary Efficacy Analysis lection of literature No restrictions in terms of publication date were applied. Flavoxate vs. Placebo In total, eight studies included 262 patients on Inclusion and Exclusion Criteria flavoxate and 233 patients on placebo. Of these Publications on either flavoxate versus com - studies, three showed a significant (p < 0.05) re - parator (placebo, oxybutynin, emepronium, duction in the risk with flavoxate as compared propantheline, phenazopyridine) or flavoxate per with placebo (Figure 2) . The overall effect size se in the treatment of OAB were included. Some favouring flavoxate was estimated to be 0.48 publications that were in non-English language (95% CI: 0.38-0.62 ) and it was statistically sig - and could not be translated to English were ex - nificant (Z = -5.721 ; p < 0.001). The Q test for cluded. heterogeneity indicates that the studies were ho - mogeneous [ p = 0.905; Q Value (I 2) = 2.774 Outcomes (0.00); df(Q) = 7]. The primary outcome was represented by the comparative assessment of flavoxate versus com - Flavoxate vs. Oxybutynin parator (placebo, phenazopyridine, oxybutynin, All the three studies that included oxybutynin propantheline, emepronium) for the overall effi - (101 patients in both the flavoxate and oxybu - cacy (defined as the global efficacy of treatment tynin group) show a similar efficacy of flavoxate with intervention in the management of OAB) and oxybutynin (Figure 2). The overall effect size and side effects profile in the symptomatic treat - favouring flavoxate was estimated to be 0.67 ment of OAB . (95% C.I: 0.38-1.17) , but it did not reach statisti - 3704 Flavoxate in the symptomatic treatment of overactive bladder: a meta-analysis Figure 1. Flow Diagram of Meta-analysis. cal significance (Z = -1.406; p = 0.160 ). The Q Flavoxate vs. Emepronium test for heterogeneity indicates that the studies Out of the three reports – involving 75 patients were homogeneous [ p = 0.477 ; Q Value (I 2) = on flavoxate and 104 patients on emepronium – 1.481 (0.00); df(Q) = 2 ]. one study showed that flavoxate is associated with significantly (p < 0.05) fewer side effects as Flavoxate vs. Others compared with emepronium (Figure 3). The Comparisons of flavoxate with emepronium or overall effect size favouring flavoxate was esti - phenazopyridine or propantheline was not ana - mated to be 0.32 (95% CI: 0.15-0.66 ) and was lyzed as the number of studies available were statistically significant (p = 0.002) . The Q test for less than three. However, flavoxate showed high - heterogeneity indicates that the studies were ho - er efficacy than emepronium in two studies 7,21 . In mogeneous [ p = 0.989; Q Value (I 2) = 0.023 other two studies 7,20 , flavoxate was overall more (0.00); df(Q) = 2]. effective than propantheline (in study 7, statistical significance was reached, p < 0.05). In another work 16 flavoxate was significantly more effective Flavoxate vs. Propantheline than phenazopyridine (p < 0.05). All the three papers comparing flavoxate with propantheline in terms of adverse effects showed a lower incidence of adverse effects
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