Urology Unit, Sapienza University of Rome, Latina, Italy.
Pediatric Urology Unit, Bambino Gesù Hospital, Rome, Italy.
Neurourol Urodyn. 2018 Mar;37(3):904-915. doi: 10.1002/nau.23391. Epub 2017 Sep 6.
OnabotulinumtoxinA (onaBNTa) for treating neurogenic detrusor overactivity (NDO) is widely used after its regulatory approval in adults. Although the administration of onaBNTa is still considered off-label in children, data have already been reported on its efficacy and safety. Nowadays, there is a lack of standardized protocols for treatment of NDO with onaBNTa in adolescent patients in their transition from the childhood to the adult age. With the aim to address this issue a consensus panel was obtained.
A panel of leading urologists and urogynaecologists skilled in functional urology, neuro-urology, urogynaecology, and pediatric urology participated in a consensus-forming project using a Delphi method to reach national consensus on NDO-onaBNTa treatment in adolescence transitional care.
In total, 11 experts participated. All panelists participated in the four phases of the consensus process. Consensus was reached if ≥70% of the experts agreed on recommendations. To facilitate a common understanding among all experts, a face-to-face consensus meeting was held in Rome in march 2015 and then with a follow-up teleconference in march 2017. By the end of the Delphi process, formal consensus was achieved for 100% of the items and an algorithm was then developed.
This manuscript represents the first report on the onaBNTa in adolescents. Young adults should be treated as a distinct sub-population in policy, planning, programming, and research, as strongly sustained by national public health care. This consensus and the algorithm could support multidisciplinary communication, reduce the extent of variations in clinical practice and optimize clinical decision making.
在监管部门批准奥那 BNTA 用于治疗成人神经源性逼尿肌过度活动症(NDO)后,其被广泛用于治疗该病。尽管在儿童中使用奥那 BNTA 仍被认为是超适应证用药,但已有相关数据报道了其疗效和安全性。目前,在青少年向成年过渡期间,缺乏关于使用奥那 BNTA 治疗 NDO 的标准化方案。为此,我们成立了一个共识专家组。
由在功能泌尿科、神经泌尿科、泌尿科妇科和小儿泌尿科方面具有丰富经验的泌尿科医生和泌尿科妇科医生组成的专家组,使用德尔菲法参与了一项共识形成项目,旨在就青少年过渡护理中使用奥那 BNTA 治疗 NDO 达成全国共识。
共有 11 名专家参与。所有小组成员均参加了共识形成过程的 4 个阶段。如果≥70%的专家同意某项建议,则达成共识。为了便于所有专家达成共识,于 2015 年 3 月在罗马举行了一次面对面的共识会议,并于 2017 年 3 月举行了一次后续电话会议。通过德尔菲法流程,最终 100%的项目达成了正式共识,并制定了一个算法。
本文代表了关于奥那 BNTA 在青少年中应用的首份报告。青年应该作为一个独特的亚人群体,在政策、规划、方案和研究中得到支持,这得到了国家公共卫生保健的大力支持。该共识和算法可以支持多学科间的交流,减少临床实践中的差异程度,并优化临床决策。