Importance Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking. Objective To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms. Design, Setting, and Participants Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017. Interventions Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207). Main Outcomes and Measures The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms. Results Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only). Conclusions and Relevance Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance. Trial Registration ClinicalTrials.gov Identifier: NCT01959347.

中文翻译：

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行为和盆底肌肉疗法联合手术与单独手术对混合性尿失禁女性失禁症状的影响

重要性 混合性尿失禁，包括压力性尿失禁和急迫性尿失禁，对女性的生活质量有不利影响。缺乏评估同时改善这两个组成部分的治疗方法的研究。目的 确定行为和盆底肌肉疗法联合尿道中段吊带是否比单独使用吊带更能改善混合性尿失禁症状。设计、设置和参与者 随机临床试验涉及 21 岁或以上有中度或重度压力和急迫性尿失禁症状至少 3 个月的女性，并且在 3 天膀胱日记中至少出现 1 次压力和 1 次急迫性尿失禁发作。该试验在美国 9 个地点进行，招募时间为 2013 年 10 月至 2016 年 4 月；最终随访 2017 年 10 月。干预 行为和骨盆底肌肉治疗（包括 1 次术前和 5 次术后 6 个月）结合中尿道吊带（n = 209）与单独吊带（n = 207）。主要结果和测量 主要结果是基线和 12 个月内混合性尿失禁症状的变化，由泌尿生殖道窘迫量表 (UDI) 长表测量；范围，0 到 300 点；最小临床重要差异，35 分，分数越高表示症状越差。结果 在随机分配的 480 名女性中（平均 [SD] 年龄，54.0 岁 [10.7]），464 名符合条件，416 名 (86.7%) 具有基线后结局数据并被纳入主要分析。联合组的 UDI 评分从基线时的 178.0 分显着下降至 12 个月时的 30.7 分，调整后的平均变化为 -128.1 分（95% CI，-146.5 至 -109.8）。仅吊带组的 UDI 评分从 176.8 分显着降低至 34.5 分，调整后平均变化为 -114.7 分（95% CI，-133.3 至 -96.2）。模型估计的组间差异（-13.4 分；95% CI，-25.9 至 -1.0；P = .04）不符合最小临床重要差异阈值。10.2% 的参与者发生了相关和不相关的严重不良事件（合并为 8.7%，仅 11.8%）。结论和相关性 在混合性尿失禁女性中，行为和盆底肌肉治疗联合尿道中段吊带手术与单独手术相比，在 12 个月时尿失禁症状存在小的统计学显着差异，但未达到预先指定的临床重要性阈值。试验注册 ClinicalTrials.gov 标识符：NCT01959347。