Prospective, Open-Label, Multi-Center, Non- Comparative Study to Assess the Safety and Efficacy of CO2 Laser System (FemiLiftTM) in the Treatment of Stress Urinary Incontinence (SUI) in Female Subjects.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Success Rate - SUI Symptom Improvement
研究概览
简要总结
This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI).
Following the screening period, including urodynamic assessment to confirm SUI, each subject will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one year. The main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit. Various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.
详细描述
Improvement in SUI symptoms as measured by the following parameters:
Objective parameters:
-
Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:
-
Number of incontinence episodes per day
-
Number of pads used per day
-
Change from baseline in 1 hour pad test 1, 2, 6 and 12 months
-
Change from baseline as assessed with Vaginal Biopsy
Subjective parameters:
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
- •Females between 30 and 75 years of age
- •Provided written Informed Consent
- •Patients with mild to moderate stress urinary incontinence (SUI) [according to the severity index developed by Sandvik]
- •Patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled
- •Normal Papanicolaou smear (up to 1 year prior to screening)
- •Negative urine culture
- •Vaginal canal, introitus and vestibule free of injuries and bleeding
- •Positive urinary stress test (Urine leakage is demonstrated while the patient is examined with full bladder in lithotomy position, and asked to perform 3 strong coughs).
排除标准
- •Positive pregnancy test
- •Planned pregnancy within the next year
- •Severe prolapse (POP>= grade 3)
- •Use of photosensitive drugs
- •Injury or/and active infection in the treatment area
- •Active vaginal infection
- •human papillomavirus/herpes simplex virus
- •Undiagnosed vaginal bleeding
- •Urge or overflow incontinence
- •Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
- •Patients with immune system diseases.
- •Patients with allergic reaction to laser.
- •Patient under treatment with photosensitivity side effects medication.
- •Obese women (BMI >30)
- •Patient unable to follow post treatment instructions.
结局指标
主要结局
Success Rate - SUI Symptom Improvement
时间窗: 6 months
Success rate - defined as an improvement in SUI symptoms as a score or 6 or 7 measured by the Patient Global Impression of Improvement (PGI-I) - 7-point Likert scale - at the 6 months visit
次要结局
- PGI-S(12 months)
- PFIQ(12 months)
- PISQ(12 months)
- 1 hour pad test(12 months)
- Urinary Diary(12 months)
- PFDI(12 months)
- Vaginal Biopsy(12 months)
- Safety Endpoint assessed by the rate of serious device related adverse events(12 months)