From the Department of Obstetrics, Gynecology and Women's Health.
Atlantic Center for Research, Atlantic Health System, Morristown, NJ.
Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):e528-e532. doi: 10.1097/SPV.0000000000000983.
Urodynamic testing of women is a common procedure to evaluate lower urinary tract symptoms but may cause discomfort. The objective of our study was to determine the effect of externally applied periurethral 2% lidocaine gel on pain scores after complex urodynamic testing in women.
This prospective, double-blinded, placebo-controlled randomized trial compared 2% lidocaine gel to water-based lubricant applied to the periurethral area before urodynamic testing in women. Discomfort was measured using a visual analog pain scale (VAS) ranging from 0 to 100. The primary outcome was the difference in VAS from baseline to 4 to 6 hours after urodynamic testing. Secondary outcomes included: VAS difference from baseline to immediately postprocedure and 24 hours after urodynamic testing; VAS scores: at baseline, immediately postprocedure, after 4-6 hours, and after 24 hours; urodynamic testing results; and any adverse events. Sixty-four women per group were needed to provide a power of 80% to detect a 10-mm difference on a 100-point VAS.
From January 2018 to March 2019, 134 subjects were randomized, 6 subjects were excluded, which resulted in 64 subjects in both the water-based lubricant group and 2% lidocaine gel group. There was no difference in baseline demographics. There was no significant difference in the change in VAS from baseline to 4 to 6 hours after UDT (0, 0 P = 0.88). No difference in secondary outcomes was noted.
Topically applied 2% lidocaine gel does not decrease pain compared with water-based lubricant. For most women, complex urodynamic testing is not associated with any significant pain.Clinical Trial Registration:www.ClinicalTrials.gov,-NCT03390790, "Lidocaine for Pain After Urodynamic Testing".
女性尿动力学检查是评估下尿路症状的常用方法，但可能会引起不适。本研究旨在确定在女性进行复杂尿动力学检查前在外阴部应用 2%利多卡因凝胶对疼痛评分的影响。
这项前瞻性、双盲、安慰剂对照随机试验比较了 2%利多卡因凝胶和水基润滑剂在外阴部使用后对女性尿动力学检查后 4 至 6 小时疼痛评分的影响。采用视觉模拟疼痛量表（VAS）评估不适程度，范围为 0 至 100。主要结局为尿动力学检查后 4 至 6 小时 VAS 基线差异。次要结局包括：VAS 基线至即刻检查后即刻、24 小时尿动力学检查后差异；VAS 评分：基线时、即刻检查后、4-6 小时后和 24 小时后；尿动力学检查结果；以及任何不良事件。每组需要 64 名女性，以提供 80%的功率来检测 100 点 VAS 上 10 毫米的差异。
2018 年 1 月至 2019 年 3 月，共有 134 名受试者被随机分配，其中 6 名受试者被排除，因此水基润滑剂组和 2%利多卡因凝胶组各有 64 名受试者。基线人口统计学特征无差异。在 UDT 后 4 至 6 小时 VAS 基线至基线的变化方面，差异无统计学意义（0，0 P = 0.88）。次要结局无差异。
与水基润滑剂相比，局部应用 2%利多卡因凝胶并不能减轻疼痛。对于大多数女性来说，复杂的尿动力学检查不会引起明显的疼痛。
