Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial
Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial
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DOI：
10.1001/jama.2019.12467
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发表时间：
2019-09-17
影响因子：
120.7
通讯作者：
Bann, Carla
中科院分区：
文献类型：
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作者：
Sung, Vivian W.;Borello-France, Diane;Bann, Carla
要点问题将围手术期行为和盆底肌肉治疗与尿道中段吊带相结合是否比单独吊带能更好地改善混合性尿失禁症状？结果在这项纳入 480 名女性的随机临床试验中，联合治疗组的尿失禁症状（通过泌尿生殖窘迫量表长表测量；范围，0-300 分；临床重要差异最小，35 分）减少了 128.2 分，单独手术组减少了 114.7 分，导致组间差异具有统计学意义，但未达到临床重要性阈值。意义在患有混合性尿失禁的女性中，尿道中段吊带手术中增加围手术期行为和盆底肌肉治疗会导致尿失禁症状的差异，但这种差异可能在临床上并不重要。重要性混合性尿失禁，包括压力性尿失禁和紧迫性尿失禁，对女性的生活质量产生不利影响。目前还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治疗与尿道中段吊带相结合是否比单独吊带更有效地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 岁或以上患有中度或重度压力性尿失禁症状和急迫性尿失禁症状至少 3 个月，且 3 天膀胱日记中至少有 1 次压力性尿失禁和 1 次急迫性尿失禁发作的女性。该试验在美国 9 个地点进行，入组时间为 2013 年 10 月至 2016 年 4 月；最后一次随访 2017 年 10 月。干预措施行为和盆底肌肉治疗（包括 6 个月内 1 次术前和 5 次术后疗程）联合尿道中段吊带 (n=209) 与单独吊带 (n=207)。主要结果和测量 主要结果是通过泌尿生殖窘迫量表 (UDI) 长表测量的混合性失禁症状在基线和 12 个月之间的变化；范围，0到300点；临床重要差异最小，为 35 分，分数越高表明症状越严重。结果在 480 名随机分配的女性（平均 [SD] 年龄，54.0 岁 [10.7]）中，464 名符合资格，416 名 (86.7%) 拥有基线后结果数据并被纳入主要分析。合并组的 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 分显着下降至 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）未达到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（合计 8.7%，仅吊索术 11.8%）。结论和相关性在患有混合性尿失禁的女性中，与单独手术相比，行为和盆底肌肉治疗联合尿道中段吊带手术导致 12 个月时尿失禁症状出现统计学上的微小差异，但未达到临床重要性的预设阈值。试验注册ClinicalTrials.gov 标识符：NCT01959347 这项优越性试验比较了行为和盆底肌肉疗法加尿道中段吊带手术与单独尿道中段吊带手术治疗女性混合性尿失禁的效果。
Key PointsQuestionDoes combining perioperative behavioral and pelvic floor muscle therapy with midurethral sling result in greater improvement in mixed urinary incontinence symptoms than does a sling alone? FindingsIn this randomized clinical trial that included 480 women, incontinence symptoms (measured by the Urogenital Distress Inventory Long Form; range, 0-300 points; minimal clinically important difference, 35 points) decreased by 128.2 points in the combined therapy group and 114.7 points in the surgery alone group, resulting in a statistically significant between-group difference that did not meet the threshold for clinical importance. MeaningAmong women with mixed urinary incontinence, the addition of perioperative behavioral and pelvic floor muscle therapy to midurethral sling surgery resulted in a difference in urinary incontinence symptoms that may not be clinically important.ImportanceMixed 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. ObjectiveTo 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 ParticipantsRandomized 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. InterventionsBehavioral 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 MeasuresThe 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. ResultsAmong 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 RelevanceAmong 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 RegistrationClinicalTrials.gov Identifier: NCT01959347This superiority trial compared behavioral and pelvic floor muscle therapy plus midurethral sling surgery with midurethral sling surgery alone in treating women with mixed urinary incontinence.