ABC Medication Dispensing Form in Efficacy and Impact of Botulinum Toxin A versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence

Study medication dispensing data, SAS
Study Description
Urinary incontinence is a condition that markedly impacts quality of life. Conservative first line treatments for urge incontinence combined with other overactive bladder (OAB) symptoms include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and are often not sustained for various reasons. Thus, the objective of the Anticholinergic versus Botox Comparison Study (ABC) was to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence (UUI). Oral anticholinergic therapy and Botox A® by injection were associated with similar reductions in the frequency of daily episodes of UUI. The group receiving Botox A® was less likely to have dry mouth and more likely to have complete resolution of UUI but had higher rates of transient urinary retention and urinary tract infections. Participants were females at least 21 years of age with urge predominant urinary incontinence based on a self-reported diary who desired treatment for urge urinary incontinence.

药物配发数据研究(SAS)
研究概况
尿失禁(Urinary incontinence)是一种显著影响生活质量的病症。针对合并其他膀胱过度活动症(OAB)症状的急迫性尿失禁(Urge incontinence)，一线保守治疗手段包括行为疗法、盆底肌训练联合/不联合生物反馈，或使用抗胆碱能药物。上述治疗手段往往无法实现完全控尿，且由于多种原因常难以维持长期疗效。因此，抗胆碱能药物与肉毒素对比研究（ABC研究）的研究目标为：评估单次膀胱内注射A型肉毒杆菌毒素(Botulinum toxin A, Botox A®)相比标准化口服抗胆碱能药物方案，在改善急迫性尿失禁(UUI)方面是否更具优势。口服抗胆碱能药物治疗与注射Botox A®均可使每日急迫性尿失禁发作次数出现相近幅度的减少。接受Botox A®注射的受试者出现口干的概率更低，完全缓解急迫性尿失禁的概率更高，但一过性尿潴留与尿路感染的发生率更高。本研究的受试者为年龄≥21岁的女性，需通过自我报告日记确诊为以急迫性症状为主的尿失禁，且存在急迫性尿失禁治疗需求。