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分比 CO2 激光治疗压力性尿失禁女性患者:一项随机对照试验。

Fractional CO laser treatment for women with stress predominant urinary incontinence: a randomized controlled trial.

机构信息

Department of Obstetrics & Gynaecology, Faculty of Medicine, Khon Kaen University, 123 Mittraphap Highway, Muang Khon Kaen, Khon Kaen, 40002, Thailand.

出版信息

Int Urogynecol J. 2023 Nov;34(11):2827-2832. doi: 10.1007/s00192-023-05655-6. Epub 2023 Oct 3.

Abstract

INTRODUCTION AND HYPOTHESIS

To evaluate the efficacy of vaginal CO laser in women with stress predominant urinary incontinence (SUI) compared with the sham treatment.

METHODS

A randomized controlled trial with sham treatment was conducted between January 2019 and April 2021. Women with predominant SUI were recruited and randomized into two groups: the CO laser group (n = 29) and the sham group (n = 30). The International Consultation on Continence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) was used to evaluate the efficacy at 3 months postoperatively. All participants in both groups were advised to perform pelvic floor muscle training (PFMT) after the intervention.

RESULTS

A total of 59 women were studied. A total of 29 women were included in the CO laser group and 30 women were included in the sham group. The baseline scores of the ICIQ-UI SF were similar in both groups. A significant improvement in urinary incontinence scores was found in both groups 3 months after treatment (p < 0.001). However, there were no statistically significant differences between the two groups at 3 months (p = 0.8281). There were no changes in bladder neck descent or levator hiatal area immediately after intervention or 3 months after completion of treatment in either group. Most participants who received the active intervention reported mild vaginal pain during the procedure that resolved spontaneously at the end of treatment.

CONCLUSIONS

Fractional CO laser treatment does not provide any benefit over the sham technique in alleviating SUI symptoms. The improvement in SUI symptoms in both groups might be related to PFMT. This study was registered with the Thai Clinical Trial Register (TCTR20190131004).

摘要

引言和假设

评估阴道 CO2 激光治疗压力性尿失禁(SUI)患者的疗效与假治疗相比。

方法

2019 年 1 月至 2021 年 4 月期间进行了一项随机对照试验和假治疗。招募以压力性尿失禁为主的女性,并将其随机分为两组:CO2 激光组(n=29)和假治疗组(n=30)。术后 3 个月使用国际尿失禁咨询委员会尿失禁问卷简表(ICIQ-UI SF)评估疗效。两组所有参与者在干预后均建议进行盆底肌训练(PFMT)。

结果

共研究了 59 名女性。共有 29 名女性纳入 CO2 激光组,30 名女性纳入假治疗组。两组的 ICIQ-UI SF 基线评分相似。治疗后 3 个月,两组的尿失禁评分均显著改善(p<0.001)。然而,两组之间在 3 个月时没有统计学上的显著差异(p=0.8281)。两组在干预后即刻或治疗完成后 3 个月时膀胱颈下降或肛提肌裂孔面积均无变化。大多数接受主动干预的参与者在治疗过程中报告有轻微的阴道疼痛,但在治疗结束时会自行缓解。

结论

与假技术相比,分数 CO2 激光治疗不能提供任何缓解 SUI 症状的益处。两组 SUI 症状的改善可能与 PFMT 有关。本研究在泰国临床试验注册中心(TCTR20190131004)注册。

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