A Clinical Study to Evaluate the Performance and Safety of the Incontinence Management Device “Contisphere ®†in Women with Urinary Stress Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To use 0 to 1 absorbent pad per day less than 7 pads per week valuated for the indwelling period of day 1
研究概览
简要总结
Urinary incontinence (UI) affects approximately 6.2% of Indian population as per study article- The epidemiology of urinary incontinence conducted by “AUSTRALIAN URINARY CONT INENCE NEEDS ANALYSISâ€. UI imposes significant adverse physical effects on patients as well as having significant psychological impact on individuals, their families and caregivers. UI results in a loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. Consequently, for women with UI, trips outside the home, social interaction with friends and family and sexual activity may be restricted or avoided entirely (Grimby, Milsom, Molander, et al., 1993).
UI can be caused by anatomic, physiologic and pathologic factors affecting the urinary tract. Subtypes of UI include urge incontinence, overflow incontinence and stress incontinence. Women with stress urinary incontinence (SUI) present clinically with involuntary loss of urine during coughing, sneezing, laughing, or other physical activities that increase intra-abdominal pressure. SUI is defined as urine loss coincident with sudden increase in intra-abdominal pressure. The most common cause of SUI in women is urethral hypermobility and may also be caused by an intrinsic urethral sphincter insufficiency (ISI). In ISI, the urethral sphincter is unable to generate enough resistance to remain completely closed to retain urine in the bladder, especially during stress manoeuvres.
Treatment modalities available for patients with SUI can be divided into three major categories: behavioural, pharmacological and surgical. As a general rule, the first choice should be the least invasive treatment with the fewest potential adverse complications that is appropriate for the patient. Although a number of treatment options have been shown to be effective alone or in combination, more research is required to determine the optimum treatment combination for specific treatment groups (Urinary Incontinence in Adults, 1996). The high prevalence of UI and its significant adverse physical and psychological effects clearly justify more aggressive efforts to identify, evaluate and treat UI in all settings. The purpose of this study is to determine if a new incontinence device will provide an additional minimally invasive treatment option for women diagnosed with SUI. The new female incontinence device is designed for placement in the bladder to prevent urine leakage while allowing the patient to control urination naturally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1- Female Patient is 18 years or older 2- Patient has a diagnosis of Grade II or III urinary stress incontinence, or intrinsic sphincteric deficiency proven by a positive provocative stress test or Patient (with mixed incontinence) in whom the bladder instability finding is not prominent 3- Patient has positive pad weight test (urine loss within 1 hour  2 g) 4- Patient is a failure of surgical treatment and/or refuses surgical intervention 5- Patient uses appropriate contraception or is post-menopausal 6- Patient is willing to comply with study requirements 7- Patient is capable of giving informed consent.
排除标准
- •1-Patient (with mixed incontinence) in whom the bladder instability finding is prominent 2- Patient has an active urinary tract infection or has had 2 diagnosed urinary tract infections in the past 6 months 3- Patient has hematuria that has not been previously evaluated and treated 4- Patient’s status is compromised by interstitial cystitis, severe diabetes, neurogenic bladder, bladder cancer, urethral structures and/or significant genital prolapse 5- Patient is carrying a pacemaker 6- Patient does suffer from reduced bladder sensation 7- Patient is pregnant (pregnancy must be ruled out by a pregnancy test for patients of childbearing potential) 8- Patient has bladder tumors or stones 9- Patient is taking medication that has an effect on continence.
结局指标
主要结局
To use 0 to 1 absorbent pad per day less than 7 pads per week valuated for the indwelling period of day 1
时间窗: 90 days
of ContiSphere insertion to Day 90 No de-novo UTI during its indwelling period
时间窗: 90 days
次要结局
- 1.Successful and safe insertion and retrieval of ContiSphere Balloon(2.Less patient discomfort during insertion and retrieval of ContiSphere Balloon as feedback)