Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence - Randomized Single Blind Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cough test
研究概览
简要总结
Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment.
详细描述
Examine the efficacy of vaginal Erbium laser treatment for stress urinary incontinence (SUI) in compare to placebo.
Plenty of women suffer from SUI. It is a condition in which involuntary urine leakage occurs during exercise. This condition affects about 40% of all women and causes huge disturbance to daily life. There are plenty of risk factors, such as age, obesity and parity. We assume that the pathophysiology is related to hypermobility of the urethra due to damage to the surrounding tissue.
The treatment options vary from surgical interventional to conservative, each treatment has its own success rate and risk factors. An attempt to find effective treatment option has been made.
The use of laser for various gynecologic conditions are at rise. ERBIUM type laser works on the lamina propria layer and causes rejuvenation probably by strengthening collagen structures and creating new ones.
The efficacy and safety of vaginal laser therapy has been proven already, but in the field of SUI the numbers in each study were low and there was no control group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women above 18 with SUI -
排除标准
- •Recurrent pelvic inflammatory disease
- •Vaginal operation in the previous year
- •Women with abnormal uterine bleeding
- •Women with diagnosed genital herpes infection
- •Any concurrent lower genital tract infection -
结局指标
主要结局
Cough test
时间窗: From enrollment up to 12 months post treatment
Results of full bladder cough test
Pad test
时间窗: From enrollment up to 12 months post treatment
Results of 24 hour pad weighing test
次要结局
- Urinary incontinence and sexuality(From enrollment up to 12 months post treatment)
- Female sexual function(From enrollment up to 12 months post treatment)
- Urinary distress index 6(From enrollment up to 12 months post treatment)
研究者
Naama Farago MD
MD
Rambam Health Care Campus