Austin Paul F, Ferguson Genoa, Yan Yan, Campigotto Mary J, Royer Michele E, Coplen Douglas E
Division of Urology, Washington University School of Medicine, St Louis Children's Hospital, St Louis, Missouri, USA.
Pediatrics. 2008 Nov;122(5):1027-32. doi: 10.1542/peds.2007-3691.
Desmopressin is an approved medical therapy for the treatment of monosymptomatic primary nocturnal enuresis. In cases of limited response to desmopressin, we have added anticholinergic therapy to desmopressin (combination therapy). To evaluate this treatment strategy, we examined the efficacy of combination therapy for primary nocturnal enuresis in desmopressin-nonresponders.
Only patients with primary nocturnal enuresis refractory to the maximal dosage of desmopressin were enrolled. Children with lower urinary tract symptoms or bowel dysfunction were excluded, on the basis of a 3-day, 24-hour, frequency-volume chart and elimination record. Children continued to take desmopressin and were assigned randomly, in a double-blind manner, to receive either extended-release anticholinergic medication or placebo. Patients were reassessed after 1 month of therapy, with a 1-week nocturnal record.
Forty-one desmopressin-nonresponders were enrolled, and 7 patients were excluded because of noncompliance. The treatment groups were equally matched with respect to age, gender, functional bladder capacity, and number of wet nights per week. After 1 month of treatment, there was a significant reduction in the mean number of wet nights in the combination therapy group, compared with the placebo group. With a generalized estimating equation approach, there was a significant 66% decrease in the risk of a wet episode, compared with the placebo group.
This study represents the first prospective, placebo-controlled trial examining the effect of desmopressin in combination with long-acting, anticholinergic, bladder-relaxing therapy for monosymptomatic primary nocturnal enuresis.
去氨加压素是一种已获批准用于治疗单症状性原发性夜间遗尿症的药物疗法。对于去氨加压素反应有限的病例,我们在去氨加压素治疗中添加了抗胆碱能疗法(联合疗法)。为评估这种治疗策略,我们研究了联合疗法对去氨加压素无反应者原发性夜间遗尿症的疗效。
仅纳入对最大剂量去氨加压素难治的原发性夜间遗尿症患者。根据3天的24小时排尿频率 - 尿量图表和排便记录,排除有下尿路症状或肠道功能障碍的儿童。儿童继续服用去氨加压素,并以双盲方式随机分配接受缓释抗胆碱能药物或安慰剂。治疗1个月后通过1周的夜间记录对患者进行重新评估。
纳入了41名去氨加压素无反应者,7名患者因不依从被排除。治疗组在年龄、性别、功能性膀胱容量和每周尿床次数方面匹配。治疗1个月后,与安慰剂组相比,联合治疗组的平均尿床次数显著减少。采用广义估计方程法,与安慰剂组相比,尿床事件风险显著降低66%。
本研究是第一项前瞻性、安慰剂对照试验,研究了去氨加压素联合长效抗胆碱能膀胱松弛疗法对单症状性原发性夜间遗尿症的效果。