Division of Urology, Centre Hospitalier Universitaire de Québec, Université Laval, Québec, Québec, Canada.
J Urol. 2010 Oct;184(4 Suppl):1668-73. doi: 10.1016/j.juro.2010.03.124. Epub 2010 Aug 21.
We evaluated the effect of solifenacin for urinary incontinence in children with overactive/neurogenic bladder refractory to oxybutynin or tolterodine.
Pediatric patients presenting with refractory overactive bladder with incontinence were offered the opportunity to enter a prospective, open label protocol using adjusted dose regimens of 1.25 to 10 mg solifenacin. Study inclusion criteria were absent correctable neurological anomalies on magnetic resonance imaging, failure of symptoms to improve on intensive behavioral and medical (oxybutynin or tolterodine) therapy, and/or significant side effects of those agents. Followup consisted of a voiding diary, post-void residual urine measurement, urine culture, ultrasound and urodynamics. Families were questioned about continence, side effects, compliance, behavior change and quality of life. The primary end point was efficacy for continence and secondary end points were tolerability and safety.
Enrolled in the study were 42 girls and 30 boys. Of the patients 27 with neurogenic bladder, of whom 11 were on clean intermittent catheterization, and 45 with overactive bladder completed a minimum 3-month followup. Patients were on solifenacin a mean of 15.6 months. Mean age at study initiation was 9.0 years. Mean ± SD urodynamic capacity improved from 146 ± 64 to 311 ± 123 ml and uninhibited contractions decreased from 70 ± 29 to 20 ± 19 cm H(2)O (p <0.01). Continence improved in all patients, including 24 who were dry, and 42 and 6 who were significantly and moderately improved, respectively. Of the patients 50 reported no side effects while 15 had mild and 3 had moderate side effects. Four patients withdrew from the protocol due to intolerable side effects. Four patients had significant post-void residual urine (greater than 20 ml).
In children with overactive bladder refractory to oxybutynin or tolterodine solifenacin is an effective alternative to improve symptoms. Tolerability was acceptable and the adjusted dose regimen appeared safe.
评估索利那新治疗对奥昔布宁或托特罗定治疗无效的逼尿肌过度活动/神经源性膀胱患儿的尿失禁的效果。
患有逼尿肌过度活动伴尿失禁的患儿，有机会参与一项前瞻性、开放标签的研究，使用 1.25 至 10mg 索利那新的调整剂量方案。研究纳入标准为磁共振成像上无可矫正的神经学异常、症状在强化行为和药物（奥昔布宁或托特罗定）治疗后无改善，和/或这些药物有显著的副作用。随访包括排尿日记、残余尿测量、尿培养、超声和尿动力学检查。询问患儿家属关于控尿、副作用、依从性、行为改变和生活质量的问题。主要终点为控尿的疗效，次要终点为耐受性和安全性。
共有 42 名女孩和 30 名男孩入组。其中 27 例为神经源性膀胱，11 例接受间歇性清洁导尿，45 例逼尿肌过度活动患儿完成了至少 3 个月的随访。患儿使用索利那新的平均时间为 15.6 个月。研究开始时的平均年龄为 9.0 岁。平均±标准差尿动力学容量从 146±64ml 增加到 311±123ml，无抑制性收缩从 70±29cmH2O 减少到 20±19cmH2O（p<0.01）。所有患者的控尿均改善，包括 24 例完全缓解，42 例和 6 例分别显著和中度改善。50 例患者报告无副作用，15 例有轻度副作用，3 例有中度副作用。4 例患者因无法耐受副作用而退出方案。4 例患者有显著的残余尿量（大于 20ml）。
对于对奥昔布宁或托特罗定治疗无效的逼尿肌过度活动患儿，索利那新是一种有效替代药物，可以改善症状。耐受性可接受，调整剂量方案似乎是安全的。
