2nd Department of Urology, Papageorgiou Hospital and Centre for Study of Continence and Pelvic Floor Dysfunctions, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Eur Urol. 2009 Jan;55(1):100-19. doi: 10.1016/j.eururo.2008.09.009. Epub 2008 Sep 17.
The increasing body of evidence and number of potential indications for the use of botulinum neurotoxins (BoNTs) in the lower urinary tract (LUT) underlines the pressing need for evidence-based guidelines.
A European expert panel consensus conference was convened with the main aim of evaluating the evidence and clinical considerations for the use of BoNTs in the treatment of urologic and pelvic-floor disorders and to propose relevant recommendations.
The quality of evidence from fully published English-language literature in the PubMed and EMBASE databases was assessed using the European Association of Urology (EAU) levels of evidence (LoE). Recommendations were graded and approved by a unanimous consensus of the panel.
The use of botulinum neurotoxin type A (BoNTA) is recommended in the treatment of intractable symptoms of neurogenic detrusor overactivity (NDO) or idiopathic detrusor overactivity (IDO) in adults (grade A). Caution is recommended in IDO because the risk of voiding difficulty and duration of effect have not yet been accurately evaluated. Repeated treatment can be recommended in NDO (grade B). The depth and location for bladder injections should be within the detrusor muscle outside the trigone (grade C). Dosage in children should be determined by body weight, with caution regarding total dose if also being used for treatment of spasticity, and minimum age (grade B). Existing evidence is inconclusive for recommendations in neurogenic detrusor-sphincter dyssynergia, bladder pain syndrome, prostate diseases, and pelvic-floor disorders. The use of BoNTA in the LUT with the current dosages and techniques is considered to be safe overall (grade A).
The consensus committee recommends larger placebo-controlled and comparative trials to evaluate the efficacy of single and repeat injections, the duration of effect, the optimal dosage and injection technique, the timing for repeat injection, and the short- and long-term safety of the treatment in LUT and pelvic-floor disorders.
越来越多的证据和潜在适应症表明，在泌尿系统（LUT）中使用肉毒杆菌神经毒素（BoNTs），突显了制定基于证据的指南的迫切需要。
召集了一个欧洲专家小组共识会议，主要目的是评估在治疗泌尿系统和盆底疾病中使用 BoNTs 的证据和临床考虑，并提出相关建议。
使用欧洲泌尿外科学会（EAU）证据水平（LoE）评估来自 PubMed 和 EMBASE 数据库中完全发表的英文文献的证据质量。建议通过小组一致同意进行分级和批准。
在成人中，推荐使用肉毒毒素 A 型（BoNTA）治疗难治性神经源性逼尿肌过度活动（NDO）或特发性逼尿肌过度活动（IDO）的症状（A级）。在 IDO 中应谨慎使用，因为排尿困难的风险和效果持续时间尚未得到准确评估。在 NDO 中可以推荐重复治疗（B 级）。膀胱注射的深度和位置应在三角区以外的逼尿肌内（C 级）。儿童的剂量应根据体重确定，如果也用于治疗痉挛，应谨慎使用总剂量，并且最小年龄（B 级）。在神经源性逼尿肌括约肌协同失调、膀胱疼痛综合征、前列腺疾病和盆底疾病方面，现有的证据尚不足以做出推荐。目前认为，以当前剂量和技术在泌尿系统中使用 BoNTA 总体上是安全的（A级）。
共识委员会建议进行更大规模的安慰剂对照和比较试验，以评估单次和重复注射的疗效、效果持续时间、最佳剂量和注射技术、重复注射的时间以及治疗泌尿系统和盆底疾病的短期和长期安全性。
