Lee Patricia, Perruzza Darian, Edell Humara, Jarvi Stephanie, Kim Katherine, Sultana Razia, Alavi Nasrin, Kiss Alex, Cao Xingshan, Gagnon Louise-Helene, Bodley Janet, Carr Lesley, Herschorn Sender, Kung Rose
Division of Urogynecology, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Sunnybrook Research Institute, Toronto, Ontario, Canada.
Am J Obstet Gynecol. 2025 Jun;232(6):541.e1-541.e12. doi: 10.1016/j.ajog.2024.11.021. Epub 2024 Nov 26.
Stress urinary incontinence affects approximately 40% of adult females and is often treated surgically. Minimally invasive vaginal laser therapy to treat stress urinary incontinence has become widely available, but the efficacy of this novel therapy is unclear.
This study aimed to determine the efficacy of erbium-doped yttrium aluminum garnet laser as a therapy for stress urinary incontinence.
This was a double-blind randomized sham-controlled trial with 6-week and 6-month follow-ups at a single tertiary hospital setting with 144 adult female patients with symptomatic stress urinary incontinence. Each participant received 2 vaginal laser therapies 6 weeks apart, with patients randomized to either laser or sham. The primary outcome was patients' subjective reporting of no urinary incontinence at 6 months after treatment on question 3 of the International Consultation on Incontinence Questionnaire-Short Form. The secondary outcomes included objective measures of urine loss with 24-hour pad tests, 3 incontinence symptom questionnaires (Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and International Consultation on Incontinence Questionnaire-Short Form), 1 quality-of-life questionnaire (King's Health Questionnaire), and 1 sexual function questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire).
Of 263 individuals approached, 76 of 144 individuals were randomized to the laser treatment group, and 68 of 144 individuals were randomized to the sham treatment group. There was no difference in the reported cure rate and the primary outcome at 6 months after treatment between the groups (laser treatment group: 0.0136; 95% confidence interval, 0.0006-0.0811; sham treatment group: 0.0000; 95% confidence interval, 0.0000-0.0666). Apart from a statistically significant difference noted at 6 weeks after treatment in 1 of 3 incontinence questionnaires and 3 of 9 domains of the quality-of-life questionnaire, there were no other significant differences in our subjective or objective measures between the 2 groups at 6 weeks and 6 months after treatment.
Er: YAG laser was no more effective than sham for curing or improving female stress urinary incontinence at 6 months.
压力性尿失禁影响约40%的成年女性，且常采用手术治疗。用于治疗压力性尿失禁的微创阴道激光疗法已广泛应用，但这种新疗法的疗效尚不清楚。
本研究旨在确定掺铒钇铝石榴石激光治疗压力性尿失禁的疗效。
这是一项双盲随机假对照试验，在一家三级医院对144名有症状的成年女性压力性尿失禁患者进行为期6周和6个月的随访。每位参与者每隔6周接受2次阴道激光治疗，患者被随机分为激光治疗组或假治疗组。主要结局是在治疗6个月后，患者根据《国际尿失禁咨询问卷简表》第3题主观报告无尿失禁。次要结局包括通过24小时护垫试验对尿量损失的客观测量、3份尿失禁症状问卷（泌尿生殖系统困扰量表-6、尿失禁影响问卷-7和国际尿失禁咨询问卷简表）、1份生活质量问卷（国王健康问卷）和1份性功能问卷（盆腔器官脱垂/尿失禁性功能问卷）。
在263名被纳入研究的个体中，144名个体中的76名被随机分配到激光治疗组，144名个体中的68名被随机分配到假治疗组。两组在治疗6个月后的报告治愈率和主要结局方面没有差异（激光治疗组：0.0136；95%置信区间，0.0006 - 0.0811；假治疗组：0.0000；95%置信区间，0.0000 - 0.0666）。除了在治疗6周后，3份尿失禁问卷中的1份以及生活质量问卷9个领域中的3个领域存在统计学显著差异外，两组在治疗6周和6个月后的主观或客观测量结果没有其他显著差异。
在6个月时，铒激光治疗在治愈或改善女性压力性尿失禁方面并不比假治疗更有效。
