NCT05882318已完成不适用
Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 14
- 主要终点
- Change in UUI Episodes Per Day
研究概览
简要总结
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is:
- The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy
Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component
- •Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS).
- •Individual is determined to be a suitable surgical candidate by physician.
排除标准
- •Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
- •Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
- •Individual has clinically significant bladder outlet obstruction.
- •Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months.
- •Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed.
- •Individual has post void residual greater than 200 cc.
- •Individual has an active diagnosis of bladder, urethral, or prostate cancer.
- •Individual has had a prior anti-stress incontinence surgery within the last year.
- •Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7).
- •Individual is neutropenic or immune-compromised.
- •Individual has lower extremity pathology such as:
- •Previous surgery and/or significant scarring at the planned implant location
- •Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders
- •Clinically significant peripheral neuropathy in the lower extremities
- •Pitting edema at the implant location (≥ 2+ is excluded)
- •Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg
- •Moderate to severe varicose veins
- •Open wounds or recent trauma
- •Arterial and/or vasculitis disease in the lower extremities
- •Chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region
- •Individual has neurogenic bladder dysfunction.
- •Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.
- •Any condition that, in the investigator's opinion, would preclude participation in the study (e.g., comorbidity that places subject at increased risk for surgical intervention, medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)
结局指标
主要结局
Change in UUI Episodes Per Day
时间窗: 3 months post-activation
The primary endpoint is to explore the effect of two different eCoin amplitude settings on the change of UUI episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
次要结局
- Change in UUI Episodes Per Day(4 months post-activation)
- Change in Overactive Bladder Health Related Quality of Life (HRQL)(4 months post-activation)
研究者
研究点 (14)
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