NCT06217328进行中（未招募）不适用
A Prospective Randomized Control Trial to Compare the Efficacy of the Revi System Therapy on Versus Off in Relieving Urinary Urge Incontinence Episodes.
BlueWind Medical38 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2024年2月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 117
- 试验地点
- 38
- 主要终点
- Primary Endpoint
研究概览
简要总结
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
详细描述
Prospective, multi-center, open label, post market, randomized controlled trial
To demonstrate superiority of Revi System therapy vs. non active therapy in the treatment of UUI
Treatment Arm:
Device: Revi System Subjects will be implanted with a Revi System and activation of therapy will occur ~4 weeks post implantation and continue for the duration of the study.
Control Arm:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent.
- •Subject is at least 18 years old, with no plans to become pregnant during the trial. If of child bearing potential and sexually active, negative pregnancy test and using acceptable contraception.
- •Subject has been diagnosed with UUI for at least 6 months.
- •Subject experiences a minimum of four (4) leaking episodes associated with urgency, with at least one episode per day for 2 days documented on a voiding diary for 3 consecutive days.
- •If used, subject should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 1 month prior to baseline and agree to remain on stable medication consumption until the 24-month follow-up visit.
- •If used, subject should be on a stable dose of tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) for at least 3 months prior to baseline.
- •Subject agrees to attend all follow-up evaluations and is willing and capable to completely and accurately fill out voiding diaries and questionnaires and is willing to complete required exams and test
排除标准
- •Subject participation in a clinical investigation with an active treatment arm within the past 90 days.
- •Subject is a high surgical risk with multiple illnesses or active general infections that expose them to excessive bleeding or delayed or non-healing wounds. This includes patients who need anticoagulation therapy that cannot be temporarily stopped for the implantation procedure.
- •Subject with BMI >
- •Subject with any metal or other implant within 20cm distance of the area of BlueWind Revi implantation site.
- •Subject variation in diuretics consumption within the last 6 months.
- •Subject has received botulinum toxin injections for OAB within the past 12 months.
- •Subject with previous urinary incontinence surgery or prolapse surgery within the last 12 months.
- •Subject has had any spinal or genitourinary surgery within the last 6 months.
- •Subject had previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male).
- •Subject with diagnosis of BPH with outflow/obstructive predominant symptoms.
- •Subject has skin, peripheral edema, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
- •Subject with Alzheimer's, Parkinson, MS, stroke (CVI), neuropathy or injury resulting in neuropathy and/or suspected neurogenic bladder.
- •Subject has recurrent urinary tract infections (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone.
- •Subject with history of chemotherapy or pelvic radiotherapy that might have affected bladder control or caused neuropathies (i.e. peripheral neuropathy).
- •Male subject who have obstructive Benign Prostatic Hyperplasia (BPH) or other lower urinary tract obstructions.
- •Subject has open wounds or sores on the lower leg or foot or had previous, unhealed trauma in the implant area or has pitting edema (≥2+) in the lower leg.
- •Subject has Venous or Arterial disease/insufficiency in the lower leg or Vasculitis or dermatologic condition in the lower leg or infections near the implantation site in the lower leg.
- •Subject has a documented history of allergic response to Platinum iridium, Titanium, Zirconia, Gold, Silicone or Parylene.
- •Subject has other active implantable electronic device/s regardless of whether stimulation is ON or OFF.
- •Subject has a life expectancy of less than 1 year.
研究组 & 干预措施
Device: Revi System Treatment Arm
Other
Subjects will be implanted with a Revi System and activation of therapy will occur ~4 weeks post implantation and continue for the duration of the study.
干预措施: Revi System Treatment (Device)
Device: Revi System - Delayed Activation Control Arm
Other
Subjects will be implanted with a Revi System and activation of therapy will be delayed until 4 months post implantation. At this time the Revi System will be activated to begin therapy and will continue for the duration of the study.
干预措施: Revi System - Delayed Activation (Device)
结局指标
主要结局
Primary Endpoint
时间窗: Month 4
Superiority of active Revi therapy over non-active therapy in the treatment of subjects with urinary urge incontinence based on a 3-day voiding diary
次要结局
未报告次要终点
研究者
研究点 (38)
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