Faculty of Medicine, Department of Urology, University of Ondokuz Mayis, Samsun, Turkey.
Faculty of Medicine, Department of Urology, University of Gaziantep, Gaziantep, Turkey.
Neurourol Urodyn. 2018 Jan;37(1):263-268. doi: 10.1002/nau.23286. Epub 2017 Apr 13.
To investigate the efficacy and safety of intradetrusor onabotulinumtoxinA (onaBoNT-A) injection in patients with overactive bladder (OAB) refractory to antimuscarinic treatment.
A total of 80 patients with OAB symptoms were enrolled in this prospective multicenter study and received 100 U intradetrusor onaBoNT-A injection.The changes from baseline in the frequency of voiding, urge urinary incontinence (UI) and urge episodes, mean and maximum bladder capacities, uroflowmetry, post-void residual urine volume (PVR), quality of life score, and treatment benefit scale score were assessed. The need for a second injection,and treatment-related adverse events were also examined postoperatively.
OnaBoNT-A injection significantly decreased the UI episodes(P = 0.0001), the mean voiding frequency (P = 0.0001), and the urgency episodes (P = 0.0001) in the third month compared to baseline. Similarly, the mean bladder capacity, and maximal bladder capacity were increased (P < 0,05). The quality of life scores improved by 57.1% compared to the pre-treatment rate (P = 0,0001). No significant change was observed in the PVR or maximum flow rate. Urinary retention developed in 3 (3.75%) patients and urinary infection and transient hematuria were observed in five patients (6.25%) each. The UI episodes, voiding frequency and urgency episodes were significantly lower at the 9th month than at baseline (all P = 0.0001). Overall 67% of the patients continued to experience benefits from the injection. Sixteen patients (20%) required a second injection in the third month. Eight patients were lost to follow-up at the last visit in the 9th month, and 34 of the remaining 56 patients required a second injection at the 9th month. Cumulatively, 50 (63%) patients needed re-injections.
Our results demonstrated that the onaBoNT-A injection produced significant improvement in all OAB symptoms with a low incidence of treatment related adverse events.
评估经尿道内注射肉毒毒素 A（onaBoNT-A）治疗抗胆碱能药物治疗抵抗的膀胱过度活动症（OAB）患者的疗效和安全性。
本前瞻性多中心研究共纳入 80 例 OAB 症状患者，接受 100U 经尿道内 onaBoNT-A 注射。评估治疗前后的排尿频率、急迫性尿失禁（UI）和急迫次数、平均和最大膀胱容量、尿流率、残余尿量（PVR）、生活质量评分和治疗获益评分的变化。术后还评估了需要第二次注射的情况和与治疗相关的不良反应。
与基线相比，onaBoNT-A 注射后第 3 个月 UI 发作（P=0.0001）、平均排尿频率（P=0.0001）和急迫发作（P=0.0001）均显著减少。同样，平均膀胱容量和最大膀胱容量也增加（P<0.05）。与治疗前相比，生活质量评分提高了 57.1%（P=0.0001）。PVR 或最大尿流率无明显变化。3 例（3.75%）患者发生尿潴留，5 例（6.25%）患者各发生 1 例尿路感染和一过性血尿。第 9 个月时，UI 发作、排尿频率和急迫发作均显著低于基线（均 P=0.0001）。总体而言，67%的患者继续从注射中获益。16 例（20%）患者在第 3 个月需要第二次注射。第 9 个月最后一次随访时有 8 例患者失访，其余 56 例患者中有 34 例在第 9 个月需要第二次注射。累计有 50 例（63%）患者需要再次注射。
我们的结果表明，onaBoNT-A 注射可显著改善所有 OAB 症状，且治疗相关不良反应发生率较低。
