Tarcan Tufan, Akbal Cem, Sekerci Cağri A, Top Tuncay, Simşek Ferruh
Division of Pediatric Urology, Department of Urology, Marmara University School of Medicine, Istanbul, Turkey.
Korean J Urol. 2014 Apr;55(4):281-7. doi: 10.4111/kju.2014.55.4.281. Epub 2014 Apr 10.
This was a prospective single-arm study to assess the efficacy and safety of intradetrusor injections of onabotulinum toxin-A in children with urinary incontinence associated with neurogenic detrusor overactivity due to myelomeningocele. All patients had failed the first-line treatment of a combination of oral antimuscarinics and intermittent catheterization.
The study group consisted of 31 children with myelomeningocele with a mean age of 7.95 years (range, 5-3 years) who were followed up for a mean of 29 weeks. The amount of onabotulinum toxin A injected was 10 U/kg with a maximal dose of 300 U. There were 20 to 30 injection sites with rigid cystoscopic guidance under general anesthesia.
Thirty of 31 patients reported dryness between intermittent catheterization intervals. The mean reduction in maximum detrusor pressure and the mean increase in maximum cystometric capacity from baseline were 53% and 51.5%, respectively, 6 weeks after injection. We found a 324% increase in mean bladder compliance and a 57% increase in mean intermittent catheterization volumes. The mean duration of efficacy was 28 weeks with a single injection and 36 weeks for repeated injections (minimum, 16 weeks; maximum, 52 weeks). The mean time interval between repeated onabotulinum toxin-A injections was 7 months (maximum, 13 months). Intradetrusor injections of onabotulinum toxin-A were well tolerated.
Onabotulinum toxin-A injections into the bladder wall provide a significant symptomatic and urodynamic improvement in children with neurogenic detrusor overactivity due to myelomeningocele who are on intermittent catheterization. The treatment seems to be safe and very well tolerated.
这是一项前瞻性单臂研究,旨在评估膀胱内注射A型肉毒杆菌毒素对因脊髓脊膜膨出导致神经源性逼尿肌过度活动所致尿失禁儿童的疗效和安全性。所有患者一线治疗采用口服抗胆碱能药物与间歇性导尿联合治疗均失败。
研究组由31例脊髓脊膜膨出患儿组成,平均年龄7.95岁(范围5 - 13岁),平均随访29周。注射的A型肉毒杆菌毒素剂量为10 U/kg,最大剂量300 U。在全身麻醉下,通过硬性膀胱镜引导进行20至30个注射点注射。
31例患者中有30例报告在间歇性导尿间隔期间出现干燥。注射后6周,最大逼尿肌压力较基线平均降低53%,最大膀胱测压容量较基线平均增加51.5%。我们发现平均膀胱顺应性增加了324%,平均间歇性导尿量增加了57%。单次注射的平均疗效持续时间为28周,重复注射为36周(最短16周;最长52周)。重复注射A型肉毒杆菌毒素的平均时间间隔为7个月(最长13个月)。膀胱内注射A型肉毒杆菌毒素耐受性良好。
对于因脊髓脊膜膨出导致神经源性逼尿肌过度活动且正在进行间歇性导尿的儿童,膀胱壁注射A型肉毒杆菌毒素可显著改善症状和尿动力学。该治疗似乎安全且耐受性良好。