Non-ablative Er:Yttrium Aluminum Garnet (Er:YAG) Laser Therapy Effect on Stress Urinary Incontinence (SUI) Related Quality of Life and Sexual Function: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 主要终点
- Change from baseline in ICIQ-UI SF score
研究概览
简要总结
Stress urinary incontinence (SUI) is a common complaint in women after childbirth. 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 control (placebo) group. Both groups were treated according to the IncontiLaseTM 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 sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the laser group will be compared to the improvement in the sham group.
详细描述
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 control (placebo) group. Both groups were treated according to the IncontiLaseTM 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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients are unaware of the assignment. Both groups were treated according to the IncontiLaseTM 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.
入排标准
- 年龄范围
- 35 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of stress urinary incontinence
- •sexually active
- •at least one vaginal delivery
排除标准
- •pelvic organ prolapse greater than stage I
- •urgency or mixed UI
- •infection
- •previous gynaecologic surgery or irradiation
- •refuse consent
研究组 & 干预措施
Laser
One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.
干预措施: laser (Device)
Sham control
The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).
干预措施: sham control (Device)
结局指标
主要结局
Change from baseline in ICIQ-UI SF score
时间窗: at 3 months after intervention
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
次要结局
- Change from baseline in FSFI score(at 3 months after intervention)
- Change from baseline in PISQ-12 score(at 3 months after intervention)
- Change from baseline in perineometry variable maximal contraction pressure(at 3 months after intervention)
- Change from baseline in perineometry variable mean muscle endurance (stamina)(at 3 months after intervention)
- Change from baseline in perineometry variable average contraction pressure(at 3 months after intervention)
研究者
Dr Adolf Lukanovič
Medical Director of the Division of Gynecology
University Medical Centre Ljubljana
