Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Pad weight test
研究概览
简要总结
The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.
详细描述
Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.
Further demographic information and patient history will be obtained from the subjects' electronic files.
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, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Negative urine analysis.
- •Normal Pap smear test from the recent 3 years.
- •No previous gynecological laser treatments.
- •Able and willing to comply with the treatment/follow-up schedule and requirements.
排除标准
- •Active genital infection.
- •Subject presenting abnormal Pap result from the last three years.
- •Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year).
- •Transvaginal mesh implant.
- •Serious systemic disease or any chronic condition that could interfere with study compliance.
- •Any vaginal bleeding of unknown reason.
结局指标
主要结局
Pad weight test
时间窗: From treatment up to 12 months post treatment
Change in pad weight
次要结局
- Urinary distress index questionnaire(From treatment up to 12 months post treatment)
- Cough test(From treatment up to 12 months post treatment)
- International consultation on incontinence questionnaire-urinary incontinence(From treatment up to 12 months post treatment)
- Pelvic organ prolapse/urinary incontinence sexual questionnaire(From treatment up to 12 months post treatment)
研究者
ROY LAUTERBACH MD
Principal investigator
Rambam Health Care Campus