Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects With Post Prostatectomy Urinary Incontinence (COMFORT STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- To establish safety of the Comfort Plug
研究概览
简要总结
Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects with Post Prostatectomy Urinary Incontinence (COMFORT STUDY)
详细描述
This is a first-in-human, device assessment, feasibility study to assess the safety, effectiveness, comfort and usability of the prototype Comfort Plug™ for controlling urinary incontinence in male subjects. 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
- •At least 6 months post radical prostatectomy for localized prostate cancer
- •Cystoscopic evaluation of the lower urinary tract within 12 months of screening
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status
- •Evidence of moderate to severe urinary incontinence as assessed by the investigator, requiring protective garments or pads
- •Post-surgical Prostate Specific Antigen (PSA) <0.04
排除标准
- •Inability to insert the Comfort Plug™ into his own urethra and remove it
- •History of significant incontinence prior to radical prostatectomy
- •Evidence of incomplete bladder emptying post radical prostatectomy
- •Recurrent , refractory bacteruria
- •Urethral stricture disease.
- •History of meatal stenosis or phimosis
- •History of any other malignancy except basal cell skin cancer
- •Planned radiotherapy for post prostatectomy residual disease within the next 90 days
- •Evidence of neurogenic bladder dysfunction
- •Multiple sclerosis or previous spinal cord trauma/pathology resulting in any neurologic deficit that, in the opinion of the investigator, might compromise the outcome
- •Ongoing constipation
- •Use of anticoagulant or antiplatelet medications excluding low-dose Acetylsalicylic acid (ASA)
- •Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve
- •Currently receiving successful medical treatment for incontinence.
- •The usage of male urethral slings
- •Planning to travel by airplane during the course of the study
结局指标
主要结局
To establish safety of the Comfort Plug
时间窗: 30 days
Safety is characterized by the absence of complications and adverse events
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
时间窗: 30 days
The ICIQ is a psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact of urinary incontinence (UI) on Quality of Life in men and women. The ICIQ-SF is scored from 0 to 21, with greater scores indicating increased severity of UI. The change from baseline (Visit Day 0) in the ICIQ-SF score at Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts) will be examined.
Weight of protective pads
时间窗: 30 days
Change from baseline (Visit Day 0) in the weight of the protective pads a Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts).
次要结局
- Incontinence Quality of Life Questionnaire (I-QOL)(30 days)