Zapico Álvaro, Ercilla Julia, Angulo Javier C, Pérez Vicente, Cuenca Juan Nicolás, Barreira-Hernández Diana, Udina-Cortés Carlos
Department of Obstetrics and Gynecology, Hospital Universitario Príncipe de Asturias, 28802 Alcalá de Henares, Spain.
Department of Surgery, Universidad de Alcalá, 28802 Alcalá de Henares, Spain.
J Clin Med. 2023 Jan 18;12(3):759. doi: 10.3390/jcm12030759.
This randomized clinical trial evaluates the success rate of neuro-adaptive therapy (NAT), applied with a specific neuro-adaptive regulator device, the Self-Controlled Electro Neuro-Adaptive Regulation (SCENAR), versus a sham for urge incontinence due to an overactive bladder (OAB). From February 2019 to May 2021, 66 patients were recruited. All subjects were randomized 1:1 at the first intervention visit to the NAT or sham procedure. Inclusion criteria were females between 18 and 80 years old with leakages due to an overactive bladder with unresponsiveness to medical therapy. Subjects were scheduled to receive up to eight weekly 20 min intervention sessions to obtain a complete (CR) or partial response (PR). Patients with no response after three sessions were considered as a failure. The primary end point of this trial was to assess the efficacy of NAT compared to an inactive sham intervention, evaluated 1 month after the last session. Analysis showed 23 (70%) patients responded (20 complete and 3 partial response) in the NAT group compared to 16 (48%) patients (all complete response) in the placebo arm ( = 0.014). Significant differences were maintained after the intervention, with persistent response at 3 months in 19 (58%) patients after active treatment and 14 (42%) after the placebo ( < 0.001), and at 6 months in 18 (55%) vs. 11 (33%) ( = 0.022), respectively. The number of sessions to achieve CR was similar in both arms, with 4.3 ± 1.9 in NAT and 3.9 ± 1.8 in the sham group (NS). Significant differences were observed between both groups for patients' satisfaction ( = 0.01). The binary model selected age as a predictor of response at the last follow-up. The odds ratio indicates that each year of increase in age, the probability of a positive response to treatment at 6 months decreases 0.95 (95% CI 0.9-0.99) times ( = 0.03). In conclusion, this pilot randomized trial gives evidence that neuro-adaptive electrostimulation is effective to treat refractory urge urinary incontinence due to OAB. The security and long-term efficacy of this treatment merits further evaluation. Moreover, its favorable profile and the economic advantages of the device make the evaluation of this promising technique mandatory in a primary therapeutic scenario.
这项随机临床试验评估了采用特定神经适应性调节设备——自控式神经适应性调节仪（SCENAR）进行的神经适应性疗法（NAT）与假治疗相比，对膀胱过度活动症（OAB）所致急迫性尿失禁的成功率。2019年2月至2021年5月，招募了66名患者。在首次干预就诊时，所有受试者按1:1随机分配接受NAT或假治疗程序。纳入标准为18至80岁因膀胱过度活动症导致漏尿且对药物治疗无反应的女性。受试者计划接受最多8次每周20分钟的干预疗程，以获得完全缓解（CR）或部分缓解（PR）。三个疗程后无反应的患者被视为治疗失败。该试验的主要终点是评估与无活性假干预相比，NAT的疗效，在最后一个疗程后1个月进行评估。分析显示，NAT组有23名（70%）患者有反应（20例完全缓解和3例部分缓解），而安慰剂组有16名（48%）患者（均为完全缓解）（P = 0.014）。干预后差异仍然显著，积极治疗后3个月，19名（58%）患者持续有反应，安慰剂组为14名（42%）（P < 0.001）；6个月时，分别为18名（55%）对11名（33%）（P = 0.022）。达到CR的疗程数在两组中相似，NAT组为4.3±1.9，假治疗组为3.9±1.8（无显著性差异）。两组患者的满意度存在显著差异（P = 0.01）。二元模型选择年龄作为最后随访时反应的预测因素。优势比表明，年龄每增加一岁，6个月时治疗阳性反应的概率降低0.95（95%可信区间0.9 - 0.99）倍（P = 0.03）。总之，这项初步随机试验证明神经适应性电刺激对治疗OAB所致难治性急迫性尿失禁有效。这种治疗的安全性和长期疗效值得进一步评估。此外，其良好的特征和设备的经济优势使得在主要治疗场景中对这项有前景的技术进行评估成为必要。
