An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 25
- 主要终点
- Stamey Grade
研究概览
简要总结
Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing. SUI affects women of all ages and can result in significant emotional distress. The purpose of this study is to evaluate a non-surgical, investigational treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.
详细描述
A multicenter, prospective, randomized, single-blinded, two-arm longitudinal trial of the safety and effectiveness of the AttenueX Device in reducing incontinence. Subjects randomized to the control arm will have the AttenueX Device inserted at the end of the 3-month control period. For those subjects who are randomized to the treatment group, the AttenueX Device will be inserted into the bladder on Day 0, and replaced every 90 days by a new device for nine months. Subjects randomized into the treatment group will be followed for a minimum of 12 months after receiving the AttenueX Device, while subjects randomized into the control group will be followed for 3 months without the AttenueX Device and a minimum of 12 months after receiving the AttenueX Device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects ≥ 18 years of age
- •Experienced stress urinary incontinence (SUI) for at least 12-months and failed prior non-surgical treatment
- •VLPP ≥ 60cm H20
- •Stamey Grade ≥ 1
- •Free of local skin infection, impassable urethral strictures, trauma or necrosis
- •Provide written informed consent
排除标准
- •Pregnant or planning pregnancy
- •3 or more urinary tract infections within previous year
- •Intrinsic sphincter deficiency
- •Incontinence surgery within previous 6-months
- •Cystocele ≥ grade 3
- •Previous pelvic radiation therapy
- •Presence of urethral abnormalities
- •Recent urosepsis
- •History of interstitial or follicular cystitis
- •Uncontrolled diabetes
- •Biofeedback within previous 3 months
- •Morbid obesity
- •Use of anticoagulants other than aspirin
结局指标
主要结局
Stamey Grade
时间窗: 6-months
次要结局
- I-QOL(6-months)
- VLPP(6-months)
- Pad Weight(6-months)
- Incontinence Episode Frequency(6-months)