Safety and Efficacy of Hybrid Fractional Laser diVa Treatment for Symptoms of Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sciton
- 入组人数
- 51
- 试验地点
- 10
- 主要终点
- Change from baseline in Cough Stress Test
研究概览
简要总结
This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.
详细描述
Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue tone and increased collagen formation in the lamina propria beneath the urethra may lead to improved urinary control. This multi-centered, 18-month prospective clinical trial will determine the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (Hybrid Fractional Laser) as an alternative non-surgical, non-hormonal treatment for improvement of symptoms of urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy biological female aged between 30 to 75 years
- •Is experiencing at least one or a combination of the following symptoms of urinary incontinence (UI)
- •involuntary urine leakage on effort, exertion, sneezing, coughing
- •sudden intense urge to urinate followed by involuntary loss of urine
- •Has been experiencing symptoms of UI for greater than 3 months
- •Normal urinalysis
- •Has indicated willingness to participate in the study by signing an informed consent form
- •Can read, understand and sign informed consent form
- •Agree to adhere to the treatment and follow-up schedule and post treatment care instructions
排除标准
- •Undiagnosed abnormal genital bleeding
- •Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment
- •Is pregnant or planning to get pregnant within the study period
- •Is currently breastfeeding
- •Has an active sexually transmitted infection (STI)
- •Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q test)
- •Has signs or symptoms of vaginitis/vulvitis
- •Has signs or symptoms of acute urinary tract infection (UTI)
- •Has voiding dysfunction or urinary retention
- •Has predominantly overactive bladder (OAB) as proven by urodynamics
- •Is currently taking medication for treating urinary incontinence
- •Has a known history of neurologic disease
- •Has history of heart failure
- •Any medical conditions that might interfere with wound healing
- •Has history of abnormal wound healing
- •Has participated in any clinical trial involving an investigational drug or procedure within past 30 days
- •The investigator feels that for any reason the subject is not eligible to participate in the study.
结局指标
主要结局
Change from baseline in Cough Stress Test
时间窗: 14 months
A diagnostic test to simulate accidental release of urine when the patient coughs.
次要结局
- Change from baseline in Incontinence Impact Questionnaire (IIQ-7)(14 months)
- Change from baseline in Urogenital Distress Inventory (UDI-6)(14 months)
- Change from baseline in Female Sexual Function Index (FSFI)(14 months)
- Change from baseline in Urodynamic Testing(14 months)
- Incidence and severity of treatment-related Adverse Events(14 months)
- Change from baseline in Histology(14 months)