近日，美国宾夕法尼亚大学Heidi S. Harvie团队比较了尿道中段悬吊术与逼尿肌内注射A型肉毒杆菌毒素治疗女性尿失禁的疗效。2025年5月5日出版的《美国医学会杂志》发表了这项成果。

混合性尿失禁包括压力性尿失禁和急迫性尿失禁，对生活质量产生不利影响，并且可能难以控制。缺乏比较混合性尿失禁手术治疗的研究。为了探讨逼尿肌内注射A型肉毒杆菌毒素治疗女性混合性尿失禁是否比尿道中段悬吊术更有效，2020年7月至2022年9月期间，研究组在在美国7个地点进行了一项随机、优越性试验，招募患有中重度压力和急迫性尿失禁的女性（年龄≥21岁），她们此前接受了不成功的保守治疗和口服药物。最后一次随访日期为2023年12月29日。

患者分为两组，分别接受逼尿肌内注射A型肉毒杆菌毒素，100U（治疗侧重于急迫性尿失禁），或者手术合成网尿道中段悬吊术（治疗侧重于压力性尿失禁）。A型肉毒杆菌毒素的接受者可以在3至6个月内接受额外注射。所有参与者都可以在6至12个月内接受额外治疗（包括与替代治疗的交叉治疗）。主要结局是6个月时混合性尿失禁症状的变化，通过泌尿生殖道不适量表（UDI）总分（0-300分；得分越高表示症状越严重；临床重要差异最小，26.1）进行测量。次要结局包括压力和刺激性UDI子评分。

在150名随机分配的女性中，137名接受了治疗，有基线后结果数据，并被纳入主要分析（平均[SD]年龄，59.0[11.5]岁）。两组在6个月时的UDI总分均有所改善，组间无显著差异（A型肉毒杆菌毒素组：-66.8分[95%CI，-84.9至-48.8]；尿道中段悬吊术组：-84.9分[95%置信区间，-100.5至-69.3]；平均差异18.1分[95%可信区间，-4.6至40.7]；P = .12）。

对于次要结局，与A型肉毒杆菌毒素组（-25.1[95%CI，-34.1至-16.1]）相比，尿道中段悬吊术组的UDI压力评分改善更大（-45.2[95%CI）（-53.7至-36.8]）（P < .001）；然而，在UDI刺激性评分方面，两组之间没有显著差异（A型肉毒杆菌毒素组：-32.9[95%置信区间，-40.3至-25.6]；尿道中段悬吊术组：-27.4[95%置信范围，-34.6至-20.3]；P = .27）。在A型肉毒杆菌毒素组中，12.7%和28.2%的患者分别在6个月和12个月时接受了第二次注射。12个月时，尿道中段悬吊术组30.3%接受A型肉毒杆菌毒素治疗，A型肉毒杆菌毒素组15.5%接受尿道中段悬吊术治疗。总体而言，各组之间的不良事件没有差异。 

研究结果表明，在先前对保守治疗没有反应的中重度混合性尿失禁女性中，A型肉毒杆菌毒素组和尿道中段悬吊术组在6个月时的UDI总分改善没有观察到差异。这些发现可能有助于根据患者的偏好和临床医生的建议做出治疗决策。

附：英文原文

Title: Midurethral Sling vs OnabotulinumtoxinA in Females With Urinary Incontinence: The MUSA Randomized Clinical Trial

Author: Heidi S. Harvie, Shawn A. Menefee, Holly E. Richter, Vivian W. Sung, Christopher J. Chermansky, David D. Rahn, Cindy L. Amundsen, Lily A. Arya, Evan Rhodes, Donna Mazloomdoost, Sonia Thomas, National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Clifford Y. Wai, Sunil Balgobin, Maria Florian-Rodriguez, Joseph I. Schaffer, Agnes Burris, Christina Hicks, Rachael Medrano, Alison Schmitt, Mary Ackenbom, Michael Bonidie, Megan Bradley, Lauren Giugale, Pamela Moalli, Halina Zyczynski, Lindsey Baranski, Rachel Durst, Uduak Andy, Zandra Kennedy, Diane Newman, Ariana Smith, Anthony Visco, Alison Weidner, Nazema Siddiqui, Stephanie Yu, Magaly Guerreo, Yasmeen Bruton, Lindsey Barden, Tucker Brenizer, Kate Burdekin, Benjamin Carper, Marie Gantz, Carolyn Huitema, Sarashwathy Veera, Ann Escher, Cassandra Carberry, B. Star Hampton, Nicole Korbly, Deborah Myers, Charles Rardin, Kyle Wohlrab, Gour Diwadkar, Jasmine Tan-Kim, Quinn Lippmann, Linda Mackinnon, Gisselle Zazueta-Damian, David Ellington, Isuzu Meyer, Sunita Patel, Emily Lukacz, Charles Nager, Marianna Alperin, Linda Brubaker, Kyle Herrala, Dulce Rodriguez-Ponciano

Issue&Volume: 2025-05-05

Abstract:

Importance  Mixed urinary incontinence, which includes both stress and urgency urinary incontinence, adversely affects quality of life and can be difficult to manage. Studies comparing procedural-based treatments for mixed urinary incontinence are lacking.

Objective  To determine whether intradetrusor onabotulinumtoxinA is more effective than midurethral sling for the treatment of mixed urinary incontinence in females.

Design, Setting, and Participants  Randomized, superiority trial involving females (aged ≥21 years) with moderate to severe bother from both stress and urgency urinary incontinence who had unsuccessful conservative treatments and oral medications. The study was conducted at 7 US sites with enrollment between July 2020 and September 2022; the last date of follow-up was December 29, 2023.

Interventions  Intradetrusor injection of onabotulinumtoxinA, 100 U (treatment focused on the urgency component), vs surgical synthetic mesh midurethral sling (treatment focused on the stress component). Recipients of onabotulinumtoxinA could receive an additional injection between 3 and 6 months. All participants could receive additional treatment (including crossover to the alternative treatment) between 6 and 12 months.

Main Outcomes and Measures  The primary outcome was change at 6 months in mixed incontinence symptoms as measured by the Urogenital Distress Inventory (UDI) total score (0-300 points; higher scores indicate worse symptoms; minimal clinically important difference, 26.1). Secondary outcomes included stress and irritative UDI subscores.

Results  Among 150 females randomized, 137 were treated, had postbaseline outcome data, and were included in the primary analysis (mean [SD] age, 59.0 [11.5] years). Both groups demonstrated mean improvement in UDI total score at 6 months with no significant difference between groups (onabotulinumtoxinA: 66.8 points [95% CI, 84.9 to 48.8]; sling: 84.9 [95% CI, 100.5 to 69.3]; mean difference, 18.1 points [95% CI, 4.6 to 40.7]; P=.12). For secondary outcomes, greater UDI stress score improvement was seen with the sling (45.2 [95% CI, 53.7 to 36.8]) compared with onabotulinumtoxinA (25.1 [95% CI, 34.1 to 16.1]) (P<.001); however, no significant difference was seen between groups in UDI irritative score (onabotulinumtoxinA: 32.9 [95% CI, 40.3 to 25.6] vs sling: –27.4 [95% CI, 34.6 to 20.3]; P=.27). In the onabotulinumtoxinA group, 12.7% and 28.2% received a second injection by 6 and 12 months, respectively. By 12 months, 30.3% in the sling group received onabotulinumtoxinA, and 15.5% in the onabotulinumtoxinA group received a sling. Overall, adverse events were not different between groups.

Conclusions and Relevance  There was no observed difference in UDI total score improvement at 6 months between the onabotulinumtoxinA and midurethral sling groups in females with moderate to severe mixed urinary incontinence who previously did not respond to conservative treatments. These findings may help inform treatment decisions based on patient preference in partnership with clinician recommendations.

DOI: 10.1001/jama.2025.4682

Source: https://jamanetwork.com/journals/jama/fullarticle/2833562