A comparison of the efficacy and tolerability of treating primary nocturnal enuresis with Solifenacin Plus Desmopressin, Tolterodine Plus Desmopressin, and Desmopressin alone: a randomized controlled clinical trial

ABSTRACT Introduction: Nocturnal enuresis (enuresis) is one of the most common developmental problems of childhood, which has often a familial basis, causes mental and psychological damage to the child and disrupts family solace. Objectives: In this study, we compared therapeutic efficacy and tolerability of treating primary nocturnal enuresis (PNE) with solifenacin plus desmopressin, tolterodine plus desmopressin, and desmopressin alone. Because we don't have enough information about this comparison especially about solifenacin plus desmopressin. Patients and Methods: This clinical trial study was performed on 62 patients with enuresis aged 5-15 years who referred to the urology clinic of Imam Khomeini Hospital in Ahwaz in 2017-2018. Patients were randomly assigned to one of the three different therapeutic protocols and any participants were given a specific code. After that, we compared the therapeutic response and the level of satisfaction of each therapeutic group in different months. Data were analyzed using SPSS 22 software and descriptive and analytical statistics. Results: The mean age of patients was 8.70±66 years. In the therapeutic group with desmopressin and solifenacin, 19 of 20 patients (95%) achieved complete remission (1) after a 3-month treatment in comparison with monotherapy group in which 14 of 22 patients (63.63%) achieved complete remission; and in the combination therapy group of desmopressin and tolterodine, in the study and the evaluation of the consequences of 3-month treatment of this group, it was found that 17 of 20 patients (85%) had complete remission. Overall, the therapeutic response in combination therapy groups of desmopressin plus anticholinergic was higher than the monotherapy group of desmopressin alone. Conclusion: Our results demonstrate that the combination of desmopressin and an anticholinergic agent is highly effective in treatment of children with PMNE. Although desmopressin has long been a first - line treatment for PMNE, desmopressin monotherapy often fails to achieve a successful response in patients with PMNE.

摘要
引言：夜间遗尿症（Nocturnal enuresis）是儿童最常见的发育障碍之一，常具有家族遗传基础，可对患儿造成精神心理损伤，并破坏家庭安宁。
研究目的：本研究旨在比较索利那新联合去氨加压素、托特罗定联合去氨加压素，以及单用去氨加压素治疗原发性夜间遗尿症（Primary Nocturnal Enuresis，PNE）的临床疗效与耐受性。鉴于目前针对该联合治疗方案，尤其是索利那新联合去氨加压素的相关对比研究数据仍较为匮乏。
患者与方法：本临床试验于2017-2018年在阿瓦士伊玛目霍梅尼医院泌尿外科门诊开展，共纳入62名5~15岁的遗尿症患儿。采用随机分组法将受试者分配至三种不同的治疗方案组中，每位参与者均分配有专属研究编号。随后比较不同治疗组在各随访月份的治疗应答情况与患者满意度水平。采用SPSS 22统计软件进行数据分析，并运用描述性与分析性统计学方法。
结果：受试患儿的平均年龄为8.70±66岁。在接受去氨加压素联合索利那新治疗的组别中，20名患儿中有19名（95%）在3个月治疗后达到完全缓解(1)；而单用去氨加压素的单药治疗组中，22名患儿仅有14名（63.63%）达到完全缓解。在去氨加压素联合托特罗定的联合治疗组中，经3个月治疗随访评估后发现，20名患儿中有17名（85%）达到完全缓解。总体而言，去氨加压素联合抗胆碱能药物的联合治疗组的治疗应答率显著高于单用去氨加压素的单药治疗组。
结论：本研究结果表明，去氨加压素联合抗胆碱能药物治疗儿童原发性夜间遗尿症具有显著疗效。尽管去氨加压素长期以来均为原发性夜间遗尿症的一线治疗方案，但单用去氨加压素往往难以使患者获得理想的治疗应答。