美国布朗大学阿尔伯特医学院Vivian W. Sung课题组近日取得一项新成果。他们的最新研究比较了行为和盆底肌疗法联合手术与单纯手术治疗混合性尿失禁的效果。该项研究成果发表在2019年9月17日出版的《美国医学会杂志》上。

2013年10月至2017年10月，研究组在美国的9个地点进行了一项随机临床试验，参与者为21岁及以上的女性，患有中重度压力性和急迫性尿失禁，持续3个月以上，且在为期3天的排尿日记中至少有1次压力性尿失禁和1次急迫性尿失禁发作。研究组共招募了416名符合条件的女性，随机分为两组，其中209名采用行为和盆底肌治疗联合尿道中段吊带术（联合治疗组），207名单纯行尿道吊带术（单纯吊带术组）。采用泌尿生殖困扰量表（UDI）对尿失禁症状进行评估，0-300分，分数越高，病情越严重。

治疗12个月后，联合治疗组的UDI评分从基线的178分降到30.7分，单纯吊带术组则从176.8分降到34.5分，两组间差异显著。共有10.2%的患者发生与治疗相关或无关的严重不良事件，其中联合治疗组8.7%，单纯吊带术组11.8%。

总之，对于混合性尿失禁的女性，行为和盆底肌疗法结合尿道中段吊带术与单纯吊带术相比，可显著改善12个月后患者的尿失禁症状。

据悉，混合型尿失禁，包括压力性和急迫性尿失禁，降低了女性的生活质量。目前缺乏同时改善两种症状的治疗方法。

附：英文原文

Title: 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

Author: Vivian W. Sung, Diane Borello-France, Diane K. Newman, Holly E. Richter, Emily S. Lukacz, Pamela Moalli, Alison C. Weidner, Ariana L. Smith, Gena Dunivan, Beri Ridgeway, John N. Nguyen, Donna Mazloomdoost, Benjamin Carper, Marie G. Gantz

Issue&Volume: Vol 322 No 11

Abstract: 

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.

DOI: 10.1001/jama.2019.12467

Source: https://jamanetwork.com/journals/jama/article-abstract/2749872