Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 12
- 主要终点
- Percentage of Patients Free of Stress Urinary Incontinence
研究概览
简要总结
The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence.
详细描述
Urinary incontinence (UI), or the complaint of any involuntary loss of urine, ranges in severity from the occasional leaking urine during actions resulting in increased abdominal pressure (coughing, sneezing, laughing, exercise, etc.) to sudden, unpredictable strong urges to void. Female stress urinary incontinence (SUI) is attributed to a weakening of the pelvic floor muscles.
A recent review of literature describing the prevalence of UI calculated the median prevalence of female UI to be 27.6% (4.8-58.4%), with the prevalence of significant incontinence increasing with age. The prevalent cause of UI was further categorized into stress (50%), mixed (32%) and urge (14%).
Nonsurgical treatment of female SUI has traditionally been limited to alpha-adrenergic agonists and estrogens, pelvic floor exercises, biofeedback, electrical stimulation and behavior modification1. Options for surgical treatment consists of periurethral injections of bulking agents, transvaginal suspensions, retropubic suspensions, slings and sphincter prostheses.
The Ajust™ Adjustable Single-Incision Sling is a fully adjustable single-incision sling that anchors in the transobturator membranes, anatomically sufficient spaces for support of the urethra.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age at least 18 years
- •Have signed an Informed Consent Form
- •Has been diagnosed with stress urinary incontinence as documented by: a minimum 30-degree urethral deflection, considered to be a candidate for transobturator repair by consulting surgeon (investigator), has a positive CST
- •Desires surgical correction of SUI using the Ajust™ Adjustable Single-Incision Sling
排除标准
- •Patient is actively participating in any other genitourinary clinical trial of an experimental drug or device
- •Patient is known to be pregnant or desiring future childbearing
- •Patient has a known urinary tract infection, or known infection in the operative field at the time of device implantation
- •Patient is unable to have their anticoagulation therapy suspended for the completion of the surgical procedure
- •Patient requires concurrent correction of pelvic organ prolapse
- •Patient has a history of previous sling procedure
- •Patient has known history of detrusor overactivity demonstrated by urodynamics
- •Patient has known urinary retention
- •Patient has a current genitourinary fistula or urinary diverticulum
- •Patient has a prior history of pelvic radiation
- •Patient has a MESA urge symptom score (% of total possible urge score) that is greater than their MESA stress symptom score (% of total possible stress score)
- •Any condition in the opinion of the Investigator that would preclude the use of the Ajust™ Adjustable Single-Incision Sling, or preclude the subject from completing the follow-up requirements
结局指标
主要结局
Percentage of Patients Free of Stress Urinary Incontinence
时间窗: 12-months post surgical procedure
Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.
Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months
时间窗: 12-months post procedure
Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).
次要结局
- Operative, Perioperative and Long-Term Complications During Operative Procedure(1 day)
- Operative, Perioperative and Long-Term Complications Perioperatively(1-15 days)
- Change in Incontinent Impact Questionnaire at 36 Months(0-36 months)
- Percentage of Patients With Impression of Improvement With Procedure at 12 Months(0-12 Months)
- Operative, Perioperative and Long-term Complications Through 36 Months(Day 15 through 36-months post procedure)
- Change in Post-operative Pain(0-7 days)
- Change in Incontinent Impact Questionnaire at 12 Months(0-12 months)
- Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months(0-36 Months)
- Percentage of Patients With Impression of Improvement With Procedure at 36 Months(0-36 Months)