Hsiao Sheng-Mou, Lin Ho-Hsiung, Kuo Hann-Chorng
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan.
Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan.
PLoS One. 2016 Jan 29;11(1):e0147137. doi: 10.1371/journal.pone.0147137. eCollection 2016.
To analyze the predictors of therapeutic efficacy after intravesical botulinum toxin A injection for overactive bladder syndrome (OAB) refractory to antimuscarinic therapy.
All consecutively OAB patients, who visited the urologic outpatient clinics of a medical center and refractory to antimuscarinic treatment, were prospectively enrolled. All enrolled patients received intravesical injection of 100 U onabotulinumtoxinA (Botox). The Global Response Assessment (GRA) score ≥ 2 at 3 months after Botox injection was defined as a successful treatment, otherwise failed.
Overall, 89 patients received intravesical injection. Eighty patients, including 42 men and 38 women, had received follow-up at 3 months. The overall success rate was 63.8%. The global response assessment, urgency severity score, urgency, urgency urinary incontinence and frequency episodes, and functional bladder capacity improved after treatment. However, post-void residual volume (PVR) increased, and voiding efficiency (VE) decreased after treatment. Female gender (odds ratio = 3.75) was the only independent factor associated with the success. Female gender (coefficient = 0.74), low baseline overactive bladder symptoms score (coefficient = -0.12) and the presence of OAB-wet (coefficient = 0.79) were independent factors associated with therapeutic efficacy (i.e., GRA score). VE (odds ratio = 0.062) was the only predictor for a large PVR at 3 months. The optimum cutoff value of VE was <87% with the area under the ROC curve being 0.64 (sensitivity = 63.8%, specificity = 57.1%).
The therapeutic effects of Botox can persist till 6 months after treatment. Female gender, low overactive bladder symptoms score and OAB-wet are associated better therapeutic efficacy, and low baseline VE is associated with large PVR. These findings can serve as an initial guide or assist in consultation regarding the treatment of OAB patients with Botox injection.
ClinicalTrials.gov NCT01657409.
分析膀胱内注射A型肉毒杆菌毒素治疗抗毒蕈碱治疗无效的膀胱过度活动症（OAB）后治疗效果的预测因素。
前瞻性纳入所有连续就诊于某医疗中心泌尿外科门诊且抗毒蕈碱治疗无效的OAB患者。所有纳入患者均接受膀胱内注射100 U的A型肉毒杆菌毒素（保妥适）。保妥适注射后3个月时全球反应评估（GRA）评分≥2定义为治疗成功，否则为失败。
总体而言，89例患者接受了膀胱内注射。80例患者（包括42例男性和38例女性）接受了3个月的随访。总体成功率为63.8%。治疗后全球反应评估、尿急严重程度评分、尿急、急迫性尿失禁和尿频发作次数以及功能性膀胱容量均有所改善。然而，治疗后排尿后残余尿量（PVR）增加，排尿效率（VE）降低。女性（比值比=3.75）是与成功相关的唯一独立因素。女性（系数=0.74）、低基线膀胱过度活动症状评分（系数=-0.12）和存在OAB-湿型（系数=0.79）是与治疗效果（即GRA评分）相关的独立因素。VE（比值比=0.062）是3个月时PVR较大的唯一预测因素。VE的最佳截断值<87%，ROC曲线下面积为0.64（敏感性=63.8%，特异性=57.1%）。
保妥适的治疗效果可持续至治疗后6个月。女性、低膀胱过度活动症状评分和OAB-湿型与更好的治疗效果相关，而低基线VE与较大的PVR相关。这些发现可作为关于保妥适注射治疗OAB患者的初步指导或协助咨询。
ClinicalTrials.gov NCT01657409
