A Prospective, Non-Randomized, Single Arm Trial to Assess the Safety and Clinical Performance of the Contino®, a Urethral Insert, in Preventing Urinary Incontinence in Male Subjects With Sphincteric Incompetence
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Change from baseline in the ICIQ-SF score
研究概览
简要总结
This trial is to assess the safety and clinical performance of Contino device is preventing Urinary Incontinence in male subjects with Sphincteric Incompetence
详细描述
Sphincteric incompetence is most commonly found in men who have had radical prostatectomy (RP). RP is the most common treatment for localized high-risk Prostate Cancer in North America.
The Contino®, a urethral insert, was conceived by a prostate cancer survivor and worn for 10+ years without incident, and a First in Human clinical trial was completed without serious adverse event. The basis for this clinical trial is a post market clinical follow-up study. No drug treatment will be administered.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 18 years of age or older
- •Evidence of sphincteric incompetence as assessed by the Investigator
- •ECOG 0 or 1 performance status
- •Evidence of moderate to severe urinary incontinence as assessed by the Investigator, typically 2 or more protective garments or pads per day
排除标准
- •Inability to consistently insert the Contino® into his own urethra and remove it
- •Less than 2 months post radical prostatectomy for localized prostate cancer
- •History of significant incontinence that is other than stress incontinence
- •Evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions
- •Untreated urethral stricture disease
- •Use of anticoagulant or antiplatelet medications excluding low-dose ASA (in the opinion of the Investigator)
- •Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve (in the opinion of the Investigator)
- •Body Mass Index (BMI) greater than 32 kg/m2 (in the opinion of the Investigator provided the subject is able to insert & remove the device)
- •Known immune deficiency either due to disease or medications (in the opinion of the Investigator)
- •Uncontrolled diabetes (in the opinion of the Investigator)
- •An UTI (in the opinion of the Investigator)
结局指标
主要结局
Change from baseline in the ICIQ-SF score
时间窗: 14 Months
At Visit Days 30 and 60
To establish the safety of the Contino®
时间窗: 14 Months
safety is characterized by the absence of complications
To establish the clinical performance of the Contino®
时间窗: 14 Months
Clinical performance is characterized by the ability to stop involuntary urine flow
Change from baseline in the weight of the protective pads
时间窗: 14 Months
At Visit Days 30 and 60
次要结局
- Level of ease of use removing the Contino® from the Follow-up Questionnaire(14 Months)
- Number of subjects with newly observed urinary function improvements(14 Months)
- Level of ease of use inserting the Contino® from the Follow-up Questionnaire(14 Months)