NCT05381116终止不适用
A Prospective, Sham-Controlled, Safety and Efficacy Study of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Modulation and Digital Health System With Objective Confirmation of Nerve Activation for Use in Home by Subjects With Overactive Bladder Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 125
- 试验地点
- 12
- 主要终点
- The proportion of Subjects with a successful response
研究概览
简要总结
This is a prospective, multi-center, sham-controlled study comparing the safety and effectiveness of the self-adjusting, surgery-free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB.
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
- Triple (Participant, Care Provider, 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
- •Male or female and 18 years of age or older at the time of enrollment
- •Willing and capable of giving informed consent
- •Willing and able to comply with all Study-related requirements and procedures
- •Have been diagnosed or have symptoms of OAB for at least 3 months prior to enrollment
- •Have an average of 11 or more voiding events and/or 3 or more incontinent events per 24-hour period in a 3-Day Bladder Diary(a minimum of 30 voiding events over the 3 days measured by the Diary)
- •If currently on medications that may affect their OAB symptoms, is on a stable dose (no new, discontinued, or change in dose) of all prescribed medications for at least 4 weeks prior to enrollment or throughout the Study
- •Female Subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline
排除标准
- •Has been diagnosed with incontinence due to neurogenic bladder(stroke, CNS tumors, Parkinson's etc.)
- •Have failed a third line treatment (PTNS, Botox or SNS) for their OAB because of lack of effectiveness within the 2 years prior to enrollment
- •Have evidence of an uncontrolled active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes, in the opinion of the Investigator
- •Has or had a significant untreated substance use disorder or polysubstance use disorder stemming from dependency-producing medications, alcohol, and/or illicit drugs less than 6 months prior to enrollment
- •Are planning to or have scheduled a surgery, for any condition, that would require catheterization, or a prolonged hospital stay and affect the ability to ambulate, use the toilet, or complete Therapy during the first 12 weeks of the Study
- •Has symptoms of, been diagnosed, or being actively treated for benign prostatic hyperplasia or prostate cancer (weak stream, straining, hesitancy, or intermittency)
- •Have a pacemaker or implanted defibrillator
- •Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas
- •Incontinence due to stress-predominant mixed urinary incontinence (greater that 60% of the time)or being actively treated for stress urinary incontinence(Diagnosed or by review of the Baseline 3-Day Bladder Diary)
- •Has been diagnosed with or has symptoms of polyuria (>2500 cc urine output per day)
- •Has urinary retention or incomplete bladder emptying
- •Have a documented current or reoccurring Urinary Tract Infection (3 or more in the months prior to enrollment)
- •Have had Botox treatment for their OAB in the previous 8 months
- •Have used TENS anywhere on the body within the last year for any reason or anticipated use of TENS within 12 weeks of enrollment in pelvic region, back or legs for any reason
- •Had PTNS treatment for OAB within 6 months prior to enrollment.
- •Use of investigational drug/device Therapy, for any reason, within past 12 weeks
- •Current use or implantation of an implanted device for treatment of their OAB or incontinence (including but not limited to sacral nerve stimulators)
- •Participation in another clinical Study during the term of the Study
- •Pregnant or planning to become pregnant during the Study. Female Subjects of childbearing potential who become pregnant during the Study will be withdrawn from the Study and will be asked to sign a separate pregnancy consent form to allow the Investigator and Sponsor to follow up on the Subject's pregnancy and outcome
- •Has scar tissue, metal, or another implant or a large tattoo that might interfere with Therapy
- •Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia)
- •Has a skin condition, for example allergic reaction, rash or open wounds, in the area of where the Therapy Garment will be placed
结局指标
主要结局
The proportion of Subjects with a successful response
时间窗: Blinded Lead-In Portion of Study,12 Weeks
The proportion of Subjects with a successful response, where success is defined as: For enrolled Subjects that meet the inclusion criteria for average voids per day (frequency): a Subject that achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 4), in average voids per day relative to an upper normal limit of an average of 8 voids per day, or For enrolled Subjects that meet the inclusion criteria for incontinence events per day: a Subject that achieves a 50% or greater reduction from baseline (Visit 1) to Week 12 (Visit 4) in average incontinence events (IE) per day.
次要结局
- Quality of Life Endpoints: Questionnaires(Length of Study, 24 months)
研究者
研究点 (12)
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