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  • This study was a prospective investigation of 89 OAB patients who were treated with intravesical injection of 100 U of onabotulinumtoxinA (Botox, Allergan, Irvine, CA, USA) from August 2012 to June 2014. All patients received for the first time Botox injection. The intravesical injections of Botox were performed at 20 different sites of the bladder wall, excluding the trigone. The inclusion criteria were urodynamically confirmed detrusor overactivity (DO) with or without urgency urinary incontinence (UUI) refractory to antimuscarinic treatment. The duration of antimuscarinic treatment should be at least 3 months. Patients had been treated with at least two different antimuscarinic agents and were still bothered by severe urgency or UUI of at least one episode per day. All patients were free of urinary tract infections, intrinsic sphincter deficiency, and neurogenic bladder on enrollment. The institutional review board of the hospital approved the study (Tzu Chi General Hospital IRB: 101–39, S1 Protocol). This study is a post hoc analysis of the above study. All patients were informed about the possible adverse events after Botox injection and written informed consent was obtained from all patients before treatment. Twenty injections (5 U in 0.5 ml normal saline for each injection) in different sites were given to the patients. Video-urodynamic studies were routinely performed for the diagnosis of DO, BOO, and intrinsic sphincter deficiency using Life-Tech urodynamics equipment (Stafford, Texas, USA). Women with BOO, detrusor underactivity (DU), and detrusor hyperactivity and inadequate contractility (DHIC) were also excluded from this study. BOO was defined as the radiologic evidence of bladder outlet narrowing plus a voiding pressure greater than 35 cm H2O and a maximum flow rate less than 15 mL/s or a voiding pressure greater than 40 cm H2O [16]. If the DO was associated with incomplete bladder emptying and PVR of more than 100 ml, DHIC was considered [17]. If patients did not have a voiding detrusor contractility of more than 10 cm H2O and needed to void by abdominal straining or were unable to void, DU was diagnosed [18]. Functional bladder capacity (FBC) was derived from 3-day voiding diary, which represents real-life bladder condition. Uroflowmetry for maximum flow rate, voided volume (VV) and PVR was performed at each visit. Total bladder capacity (TBC) was derived from the sum of voided volume (VV) and PVR. Voiding efficiency (VE) was defined as VV divided by TBC [19]. The urgency severity scale (USS) was measured using a modified version of the validated Indevus Urgency Severity Scale, which rated urgency severity by circling 0, 1, 2, or 3, defined as none, mild, moderate, and severe urgency, respectively [20]. In addition to the USS, which ranged from 0–3, we defined urgency incontinence as an UI score of 4. Besides, the overactive bladder symptom score (OABSS) [21] was also measured at each visits. OAB-wet was diagnosed while the presence of at least one episode of urgency incontinence in her 3-day bladder diary; otherwise, OAB-dry. All patients were closely monitored monthly by personal interview after treatment for up to 6 months after the Botox injection. Any adverse events considered possibly related to Botox treatment were recorded. The therapeutic efficacy was graded based on the Global Response Assessment (GRA, categorized into -3, -2, -1, 0, 1, 2, and 3, indicating markedly worse, moderately worse, mildly worse, no change, mildly improved, moderately improved, and markedly improved bladder symptoms, respectively). At 2 weeks, 1, 3 and 6 months after the Botox injection, patients were requested to report their subjective perception of the bladder condition which must be balanced by the improvement of OAB symptoms and any adverse effect emerged after Botox treatment. A GRA ≥ 2 at 3 months after Botox injection was defined as a successful treatment, otherwise failed [22]. The STATA software (Version 11.0; Stata Corp, College Station, TX, USA) was used for the statistical analyses. The Skillings-Mack test and Wilcoxon sign-rank test were used, as appropriate. The variables in the univariate regression analysis included gender, age, OABSS scores, USS scores, bladder diary and uroflowmetry variables, and the presence of OAB-wet. Multivariate backward stepwise regression analysis was performed using all variables from the univariate analysis. A P value of less than 0.05 was considered statistically significant. Receiver operating characteristic (ROC) curve analysis was performed to identify the optimal cutoff value for predicting the large PVR (i.e., defined as > 150 ml) after treatment. The optimal cutoff value was determined by the point on the ROC curve closest to the upper left-hand corner.
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