Er:YAG laser in hysterectomized women with stress urinary incontinence: a VELA retrospective cohort, non-inferiority study

Abstract

Objective: To test whether the erbium-doped yttrium aluminum garnet (Er:YAG) SMOOTH^® laser treatment efficacy on stress urinary incontinence (SUI) in hysterectomized patients is non-inferior to its efficacy in non-hysterectomized patients.

Methods: In this real-world, retrospective cohort study performed in Turkey, Croatia and Italy, we enrolled a consecutive sample of 35 hysterectomized and 34 non-hysterectomized patients with SUI. We used the Er:YAG SMOOTH^® laser (Fotona, Slovenia) with a wave length of 2940 nm. The primary outcome was median reduction of SUI symptoms measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-SF) with the non-inferiority margin defined as the minimum clinically important difference of ICIQ-SF (δ < 2.52 points).

Results: In hysterectomized patients, the ICIQ-SF was reduced by 5 points (95% confidence interval 3–8; p < 0.001), a reduction of 45% (95% confidence interval 36–67%). After adjustment for baseline ICIQ-SF and five covariates, the reduction of symptoms in the hysterectomized group was not inferior to the reduction in the non-hysterectomized group.

Conclusion: The Er:YAG SMOOTH^® laser treatment seems to improve the symptoms of SUI in hysterectomized women not clinically relevantly less than in non-hysterectomized women. It seems that the beneficial effect of Er:YAG SMOOTH^® laser treatment for SUI in hysterectomized women is time-limited.

摘要

目的：为了测定掺铒钇铝石榴石（Er：YAG）SMOOTHV^®激光治疗对子宫切除术患者压力性尿失禁（SUI）的疗效是否不次于其对子宫未切除患者的疗效。

方法：在土耳其、克罗地亚和意大利进行的这项真实世界回顾性队列研究中, 我们连续纳入了35例子宫切除术的SUI患者和34例子宫未切除的SUI患者。我们采用了波长为2940 nm的Er：YAG SMOOTHV^®激光器（Fotona, Slovenia）。主要结局是根据国际尿失禁咨询委员会尿失禁问卷简表（ICIQ-SF）测得的SUI症状中位数降低, 非劣效性界值定义为ICIQ-SF的最小临床重要差异（ẟ<2.52分）。

结果：接受子宫切除术的患者中, ICIQ-SF降低了5分（95％置信区间3-8；p <0.001）, 降低了45％（95％置信区间36-67％）。在对基线ICIQ-SF和五个协变量进行调整后, 子宫切除术组的症状减轻不次于非子宫切除组的症状减轻。

结论：Er：YAG SMOOTHV^®激光治疗似乎可以改善子宫切除术女性的SUI症状, 但在临床上并没有比非子宫切除的女性少。似乎, Er：YAG SMOOTHV^®激光治疗对子宫切除后女性SUI的有益作用是有时间限制的。

Keywords:

• Stress urinary incontinence
• hysterectomy
• Er:YAG SMOOTH^® laser

Potential conflict of interest

The authors declare no conflict of interest. The authors alone are responsible for the content and writing of the paper.

Source of funding

Nil. The study was funded by the authors.