Department of Urology, Cairo University, Cairo, 11562, Egypt.
Department of Urology, Theodor Bilharz Research Institute, Giza, 12411, Egypt.
World J Urol. 2017 Aug;35(8):1261-1268. doi: 10.1007/s00345-016-1988-y. Epub 2017 Jan 3.
We aimed to compare the safety and efficacy of solifenacin versus trospium chloride and compare each drug versus placebo regarding the relief of stent-related symptoms following uncomplicated ureteroscopic lithotripsy (URSL).
In a prospective, randomized, double-blind study, 210 eligible patients who underwent URSL with double-J stent insertion were recruited and randomly assigned to either the first group, receiving solifenacin (10 mg), second group, receiving trospium chloride (60 mg), or the third group, receiving placebo (one tablet). All patients were kept on study medication once daily during the entire 2-week postoperative period. All subjects were asked to complete a brief-form questionnaire to assess the lower urinary symptoms, stent-related body pain and hematuria, preoperatively and 2 weeks postoperatively.
There were no statistically significant differences among the study groups in terms of mean age, gender, anthropometric measurements, stone and stent criteria. The overall symptom score, urgency, urge incontinence, flank pain, urethral pain and gross hematuria scores were significantly lower in solifenacin group compared to trospium chloride and placebo groups (p < 0.001). Concerning frequency and nocturia, there was no significant difference in mean scores across all groups. Drug-related side effects, particularly constipation, were higher in trospium group than in solifenacin one.
Solifenacin treatment showed significant improvement in almost all domains of stent-related symptoms than trospium. In terms of safety and tolerance, both drugs were comparable. Future studies should be designed to address the impact of combined drugs and lower doses in the management of DJ stent-related symptoms.
比较索利那新与托特罗定治疗单纯输尿管镜碎石术后（URSL）留置双“J”管相关症状的安全性和疗效，并比较每种药物与安慰剂相比在缓解支架相关症状方面的效果。
前瞻性、随机、双盲研究中，210 例接受 URSL 加双“J”管置入术的合格患者被招募并随机分为三组：第一组接受索利那新（10mg）治疗，第二组接受托特罗定（60mg）治疗，第三组接受安慰剂（一片）治疗。所有患者在术后 2 周的整个期间每天服用一次研究药物。所有患者均在术前和术后 2 周填写简短问卷评估下尿路症状、支架相关躯体疼痛和血尿。
在年龄、性别、人体测量学指标、结石和支架标准方面，研究组之间无统计学差异。与托特罗定和安慰剂组相比，索利那新组的总体症状评分、尿急、急迫性尿失禁、肋脊角疼痛、尿道疼痛和肉眼血尿评分明显更低（p<0.001）。关于频率和夜尿，所有组的平均评分均无显著差异。托特罗定组的药物相关副作用，尤其是便秘，高于索利那新组。
与托特罗定相比，索利那新治疗在支架相关症状的几乎所有方面都有显著改善。在安全性和耐受性方面，这两种药物相当。未来的研究应设计解决联合用药和较低剂量在 DJ 支架相关症状管理中的影响。
