BACKGROUND Stress urinary incontinence affects approximately 40% of adult females and is often treated surgically. Minimally invasive laser vaginal therapy to treat stress urinary incontinence has become widely available, but the efficacy of this novel therapy is unclear. OBJECTIVE To determine the efficacy of Erbium-Yttrium Aluminum Garnet (Er-YAG) laser therapy as a treatment for stress urinary incontinence. STUDY DESIGN Randomized sham-controlled, double-blinded trial with 6-week and 6-month follow-up at a single tertiary hospital setting with 144 adult female patients with symptomatic stress urinary incontinence. Each participant received two vaginal laser treatments 6-weeks apart, with patients randomized to either laser or sham. The primary outcome was patients' subjective reporting of no urinary incontinence 6-months post-treatment on question 3 of the International Consultation on Incontinence Questionnaire-Short Form. Secondary outcomes included objective measures of urine loss with 24-hour pad tests, three incontinence symptom questionnaires (using Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and International Consultation on Incontinence Questionnaire-Short Form questionnaires), one quality of life questionnaire (King's Health Questionnaire) and one sexual function questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire). RESULTS Of 263 approached, 76/144 and 68/144 were randomized to the laser and sham treatment group respectively. There was no difference between the groups in the reported cure rate, the primary outcome, at 6-months: Laser group, 0.013 (1/76) with 95% confidence interval (0.0006-0.0811) and sham group, 0/68 with 95% confidence interval (0-0.0666). Apart from a statistically significant difference noted at 6-weeks 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 two groups at 6-weeks and at 6-months post treatment. CONCLUSION Er-YAG laser vaginal treatment was no more effective than sham for curing or improving female stress urinary incontinence at 6-months.

中文翻译：

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Erbium-YAG 激光治疗女性压力性尿失禁的双盲随机对照试验。


背景 压力性尿失禁影响大约 40% 的成年女性，通常通过手术治疗。治疗压力性尿失禁的微创激光阴道疗法已广泛使用，但这种新疗法的疗效尚不清楚。目的 确定铒钇铝石榴石 （Er-YAG） 激光治疗压力性尿失禁的疗效。研究设计 随机、假对照、双盲试验，在一家三级医院对 144 名患有症状性压力性尿失禁的成年女性患者进行了为期 6 周和 6 个月的随访。每个参与者接受两次阴道激光治疗，间隔 6 周，患者随机接受激光或假治疗。主要结局是患者在治疗后 6 个月对国际尿失禁咨询问卷 - 简表问题 3 的主观报告无尿失禁。次要结局包括通过 24 小时垫测试客观测量尿失禁、3 份失禁症状问卷 （使用泌尿生殖系统痛苦量表 6、失禁影响问卷 7 和国际尿失禁咨询问卷 - 简式问卷）、1 份生活质量问卷 （King's Health Questionnaire） 和 1 份性功能问卷 （盆腔器官脱垂/尿失禁性问卷）。结果 在 263 例入组病例中，76/144 例和 68/144 例分别随机分配到激光组和假治疗组。两组之间报告的治愈率（主要结局）在 6 个月时没有差异： 激光组，0.013 （1/76），95% 置信区间 （0.0006-0.0811），假手术组，0/68,95% 置信区间 （0-0.0666）。 除了在 3 份失禁问卷中的 1 份和生活质量问卷的 9 个领域中的 3 份在 6 周时观察到统计学上的显着差异外，在治疗后 6 周和 6 个月时，两组之间的主观或客观测量没有其他显着差异。结论 Er-YAG 激光阴道治疗在 6 个月时治愈或改善女性压力性尿失禁的效果并不比假手术更有效。