Blaganje Mija, Šćepanović Darija, Žgur Lidija, Verdenik Ivan, Pajk Franja, Lukanović Adolf
Department of Gynecology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
LA&HA-Laser and Health Academy, Stegne 3, Ljubljana, Slovenia.
Eur J Obstet Gynecol Reprod Biol. 2018 May;224:153-158. doi: 10.1016/j.ejogrb.2018.03.038. Epub 2018 Mar 22.
Stress urinary incontinence (SUI) is a common complaint in women after childbirth. It affects their quality of life and sexual satisfaction and is one of the major reasons for gynaecological surgery. There is a need for effective non-invasive treatment alternatives. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women.
114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham group. Both groups were treated according to the IncontiLase clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity and sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. Validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) was used as the primary outcome measure. The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire short form (PISQ-12) and The Female Sexual Function Index (FSFI) were used to assess the sexual function. Patients were monitored for discomfort and side-effects during treatment and follow-up period.
3 months after treatment the ICIQ-UI SF (p < 0.001), PISQ-12 (p = 0.014) and FSFI (p = 0.025) scores were significantly more improved in the laser group than in the sham control group. All perineometry variables improved in the laser group after treatment; duration and maximum pressure had statistically significantly better improvement than the sham group, whereas average pressure did not. 21% of laser treated patients were dry (ICIQ-UI SF = 0) at follow up compared to only 4% of the sham control patients. No serious adverse effects were observed or reported. The treatment was well tolerated by patients.
The non-ablative Er:YAG laser therapy improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo. It provides a promising minimally-invasive safe treatment alternative for SUI.
压力性尿失禁（SUI）是产后女性的常见问题。它会影响她们的生活质量和性满意度，是妇科手术的主要原因之一。需要有效的非侵入性治疗方法。本研究的目的是评估非剥脱性铒激光治疗压力性尿失禁及改善经产妇性满足感的疗效和安全性。
114名患有压力性尿失禁的绝经前经产妇被随机分为两组，每组57名女性；激光干预组和假手术组。两组均按照IncontiLase压力性尿失禁临床治疗方案，使用仅产生非剥脱性热效应的铒激光进行治疗，不同的是假手术组治疗时无能量输出。患者对分组情况不知情。在基线和治疗后3个月对患者进行临床检查，让患者回答压力性尿失禁严重程度和性功能评估问卷，并通过会阴压力测量法评估其盆底肌肉（PFM）功能。采用经过验证的国际尿失禁咨询委员会尿失禁简表（ICIQ-UI SF）作为主要结局指标。使用盆腔器官脱垂尿失禁性功能问卷简表（PISQ-12）和女性性功能指数（FSFI）评估性功能。在治疗和随访期间对患者的不适和副作用进行监测。
治疗3个月后，激光组的ICIQ-UI SF（p < 0.001）、PISQ-12（p = 0.014）和FSFI（p = 0.025）评分较假手术对照组有显著改善。激光组治疗后所有会阴压力测量变量均有改善；持续时间和最大压力的改善在统计学上显著优于假手术组，而平均压力则不然。随访时，激光治疗组21%的患者尿失禁症状消失（ICIQ-UI SF = 0），而假手术对照组仅为4%。未观察到或报告有严重不良反应。患者对该治疗耐受性良好。
非剥脱性铒激光治疗对绝经前经产妇压力性尿失禁症状对生活质量和性功能的影响的改善明显优于安慰剂。它为压力性尿失禁提供了一种有前景的微创安全治疗选择。
