跳至主要内容
临床试验/NCT03296241
NCT03296241已完成不适用

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

Dr Adolf Lukanovič0 个研究点目标入组 114 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

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

Experimental

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

Sham Comparator

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

发起方
Dr Adolf Lukanovič
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Adolf Lukanovič

Medical Director of the Division of Gynecology

University Medical Centre Ljubljana

相似试验