The objective of this systematic review and meta-analysis was to evaluate the efficacy and the effectiveness, as well as the safety and tolerability, of urethral bulking agents (UBAs) in women with mixed or stress urinary incontinence. PubMed, Scopus, and the Cochrane Central Register of Controlled Trials were used to identify relevant articles. In total, 3510 records were found. A total of 42 full texts were evaluated but only 21 (48.8 %) were selected for the qualitative and quantitative analysis. The pooled improvement rate in studies with a follow-up of ≤1 and >1 year was 46.0 % (95 % CI: 37.0 %-57.0 %; I2: 88.9 %) and 57.0 % (95 % CI: 39.0 %-74.0 %; I2: 89.6 %), respectively. The outcome 'cure/dryness' ranged from 9.1 % to 56.7 %. The pooled cure rate was 26.0 % (95 % CI: 21.0 %-32.0 %; I2: 89.9 %) and 21.0 % (95 % CI: 16.0 %-27.0 %; I2: 34.2 %) in females with a follow-up of ≤1 and >1 year, respectively. The treatment success rate ranged from 32.7 % to 93.3 % in 12 studies; it was objectively assessed with different tools (e.g., the Stamey scale in 5 studies). The pooled objective treatment success rate was 7.0 % (95 % CI: 59.0.0 %-75.0 %; I2: 82.4 %) and 46.0 % (95 % CI: 37.0 %-55.0 %; I2: 55.3 %) in women with a follow-up of ≤12 and >12 months, respectively. The percentage of adverse events was 0.4 % (vaginal infection, irritation, lichen sclerosus, worsening urinary incontinence). However, the use of UBAs as the first-line therapy should be demonstrated in more comparative studies (randomized studies MUSs vs. UBAs). UBAs should be considered a first-line surgical therapy only for women with SUI and mixed UI with high anaesthesia risk, elderly patients, or patients reluctant to undergo surgery. Thus, UBAs should not be offered as first-line therapy for those women desiring a "one-time" durable solution for primary or recurrent SUI.

中文翻译：

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填充剂治疗压力性和混合性尿失禁的疗效和有效性：系统评价和荟萃分析

本系统评价和荟萃分析的目的是评估尿道填充剂 (UBA) 对混合性或压力性尿失禁女性的疗效和有效性以及安全性和耐受性。PubMed、Scopus 和 Cochrane Central Register of Controlled Trials 用于识别相关文章。总共找到了 3510 条记录。共评估了 42 篇全文，但仅选择了 21 篇（48.8%）进行定性和定量分析。随访 ≤ 1 年和 > 1 年的研究的汇总改善率为 46.0 %（95 % CI：37.0 %-57.0 %；I2：88.9 %）和 57.0 %（95 % CI：39.0 %-74.0 % ；I2：分别为 89.6%)。结果“治愈/干燥”的范围从 9.1% 到 56.7%。合并治愈率为 26.0 %（95 % CI：21.0 %-32.0 %；I2：89.9 %）和 21.0 %（95 % CI：16.0 %-27）。0%; I2：34.2 %) 分别在随访时间≤1 年和>1 年的女性中。在 12 项研究中，治疗成功率从 32.7% 到 93.3% 不等；使用不同的工具（例如，5 项研究中的 Stamey 量表）对其进行了客观评估。合并客观治疗成功率为 7.0 %（95 % CI：59.0.0 %-75.0 %；I2：82.4 %）和 46.0 %（95 % CI：37.0 %-55.0 %；I2：55.3 %）。分别≤12个月和>12个月的随访。不良事件的百分比为 0.4%（阴道感染、刺激、硬化性苔藓、尿失禁恶化）。然而，应在更多的比较研究（随机研究 MUS 与 UBA）中证明使用 UBA 作为一线治疗。UBAs 应考虑仅用于 SUI 和具有高麻醉风险的混合 UI 的女性、老年患者、或不愿接受手术的患者。因此，对于希望“一次性”持久解决原发性或复发性 SUI 的女性，不应将 UBA 作为一线治疗。