Double-blind, Randomized, Shame-controlled Multicenter Clinical Study to Evaluate Efficacy and Safety of Low-level Light Therapy Device(Color DNA-WSF) for the Treatment of Overactive Bladder and Urinary Incontinence in Women
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Frequency of urinary incontinence episode
研究概览
简要总结
This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary Incontinence (UI)
详细描述
Study design: This was a prospective, randomized, double-blind, placebo-controlled, multi-centered trial carried out at two university hospitals. This clinical trial was approved by the Korea Food and Drug Administration and the Institutional Review Boards of the two hospitals.
Study process:
All patients gave informed written consent after being informed of the details of the study. Participants were randomized into either the LLLT or placebo control groups at the third visit. All participants underwent demographic and history taking, a physical examination, bladder examination and laboratory tests. All participants were educated on how to use the device by demonstration and a picture-guided user manual.
During the second visit, the participants conducted a self-evaluation of frequency of urgency urinary incontinence episode using the OABSS scale and underwent urine examination (pre-treatment measurement). The third visit occurred 7 days from the date of the second visit, and a clinical primary nurse described how to use the medical equipment and devices when they were at home. All subjects filled out self-reported diary and filled out UDI-6 and IIQ-7 questionnaires in each visit. Subjects carried out the self-treatment in the same way at home 3 times a day for 12 weeks and then visited the hospital at week 4 and 12 to undergo examination and filled out OABSS, UDI-6 and IIQ-7 questionnaires (post-treatment measurement).
Statistical analysis:
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of overactive bladder or urinary incontinence
排除标准
- •History of taking medication for urgency urinary incontinence,
研究组 & 干预措施
LLLT group
Low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each
干预措施: Low-level light therapy (Device)
Placebo-controlled group
Placebo low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.
干预措施: Placebo (Device)
结局指标
主要结局
Frequency of urinary incontinence episode
时间窗: within 12 weeks after treatment
The primary outcome was frequency of urgency urinary incontinence episode based on the self-evaluated micturition diary measuring the difference between urgency urinary incontinence episode count pre and post-treatment. Urgency urinary incontinence episode was measured by the mean of 3 days report prior to the visit (week 0, 4 and 12). The higher values represent a worse outcome. All data collected by self-reported sheet. The participants conducted a self-evaluation of frequency of urgency urinary incontinence episode from 3 days prior to the visits and submitted to the investigator.
次要结局
- Changes in Quality of life(within 12 weeks after treatment)