Abstract
Purpose
This study aims to assess the effectiveness of the non-ablative photothermal erbium laser (Er:YAG laser) for managing anterior and/or posterior vaginal compartment prolapse.
Methods
A randomized, single-blind, 1:1 trial was performed comparing Er:YAG laser treatment to watchful waiting in postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 who opted to undergo surgery due to bothersome prolapse symptoms. Three Er:YAG laser treatments at monthly intervals were applied for the Er:YAG laser group, while there was no treatment for the watchful-waiting group. The primary outcome was the proportion of patients with stage 0 or 1 following laser treatment, while secondary outcomes included the Pelvic Organ Prolapse Quantification System (POP-Q points), Pelvic Floor Distress Inventory Questionnaire short-form, Pelvic Floor Impact Questionnaire short-form, and Patients Global Impression of Improvement (PGI-I). All outcomes were evaluated at baseline and 4 months post baseline.
Results
Thirty women (15 vs. 15) were eligible to be included. No participants (0%) in either group had POP-Q stage 0 or 1 at 4 months. Moreover, no change was present in the secondary outcomes. In the PGI-I, 2/15 (14%) and 0/15 (0%) participants declared much better/very much better in the laser and watchful-waiting group, respectively.
Conclusions
The findings of this study do not support use of the intravaginal Er:YAG laser for treatment of the anterior/posterior vaginal wall.
Clinical trial identification number: NCT03714607
摘要
目的:本研究旨在评估非烧蚀性光热激光(Er:YAG激光)治疗阴道前壁和/或后壁脱垂的有效性。方法:本研究进行了一项随机, 单盲, 1:1试验, 比较选择手术治疗的有症状的2或3期膀胱膨出和/或直肠膨出的绝经后女性Er:YAG激光治疗和观察等待的效果。 Er:YAG激光治疗组每月进行3次Er:YAG激光治疗, 而等待观察组则没有治疗。主要结局是接受激光治疗后为0或1期患者的比例, 而次要结局包括盆腔器官脱垂定量(POP-Q分值), 盆底功能障碍问卷简表, 盆底功能影响问卷简表, 以及患者对改善的总体印象(PGI-I)。在基线和基线后4个月评估所有结果。结果:30名女性(15比15)符合纳入条件。两组中没有参与者(0%)在4个月时POP-Q为 0或1期。此外, 次要结局无变化。在PGI-I中, 激光和等待观察组分别有2/15(14%)和0/15(0%)的参与者表示好一些/好得多。结论:这项研究的结果不支持使用阴道内Er:YAG激光治疗阴道前/后壁脱垂。
临床试验编号:NCT03714607
Potential conflict of interest
None.
Source of funding
None.