A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months (INTIBIA Pivotal Study IU024)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 208
- 试验地点
- 22
- 主要终点
- Response Rate
研究概览
简要总结
Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
详细描述
All eligible subjects will be implanted with the INTIBIA device. Subjects will be randomized to either INTIBIA therapeutic or INTIBIA non-therapeutic in a 2:1 ratio for the first 3 months of the study, at which point all subjects will receive therapeutic stimulation. Subjects will complete voiding diaries and questionnaires at Baseline and prior to each follow-up visit, which will occur at Months 3, 6, 12, and 24. Subjects will be offered to keep the device or have it explanted at the end of the study.
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)
盲法说明
Subjects and investigator/site personnel are blinded until the Month 3 visit.
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men 22-80 years of age
- •Symptoms of overactive bladder with urgency urinary incontinence (UUI) demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, and at least one leaking episode each 24-hour period
- •Greater than or equal to 6-month history of UUI diagnosis
- •Failure of conservative or behavioral therapy (e.g., bladder diet, timed voiding, bladder training, bladder control strategies, pelvic floor muscle training, fluid management)
- •Willing to abstain from OAB medications for the duration of the study
- •Willing to maintain a stable dose of all other medications that affect bladder function (e.g., tricyclic antidepressants) for at least four (4) weeks prior to beginning the baseline voiding diary and baseline questionnaires
- •Ambulatory and able to use the toilet independently and without difficulty
- •Willing and capable of providing informed consent
- •Willing and able to complete all procedures and follow-up visits indicated in the protocol
排除标准
- •Diagnosis of stress urinary incontinence or mixed urinary incontinence, as confirmed by cough stress test and with a response of Yes to Q3 on the UDI-6 questionnaire
- •Current symptomatic urinary tract infection (UTI), urethritis, or more than three (3) UTIs in past year
- •Have post-void residual urine volume >30% of total voided volume
- •Inadequate skin integrity, any evidence of an infection, or lower leg edema limiting placement of device per physician discretion
- •Evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject
- •Prior treatment of urinary symptoms with nerve stimulation (e.g., percutaneous tibial nerve stimulation [PTNS] or sacral nerve stimulation [SNS])
- •History of chronic pain (e.g., chronic pelvic pain, fibromyalgia, Lyme disease, chronic back pain)
- •An active implantable electronic device regardless of whether stimulation is ON or OFF
- •Treatment of urinary symptoms with botulinum toxin therapy within six (6) months
- •Any neurological condition that could interfere with normal bladder or tibial nerve function, including debilitating stroke, epilepsy, multiple sclerosis, Parkinson's disease, peripheral neuropathy, fibromyalgia, or spinal cord injury (e.g., paraplegia)
- •Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
- •Other urinary tract dysfunction (e.g., abnormal upper urinary tract function, vesicoureteral reflux, bladder stone or tumor, urinary fistula)
- •End stage renal failure, GFR < 35, or dialysis
- •History of pelvic cancer requiring radiation or chemotherapy treatment within the past two years
- •Pelvic organ prolapse at or beyond the hymenal ring
- •Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines prior to INTIBIA implant date
- •Diabetes with peripheral nerve compromise or uncontrolled diabetes
- •Pregnant as confirmed by urine or serum pregnancy test, plans to become pregnant over the study period, is less than one-year post-partum, is breast-feeding
- •Current active or a chronic systemic infection
- •Condition requiring magnetic resonance imaging (MRI) of lower leg
- •Condition requiring diathermy
- •Allergy to polyethylene terephthalate, silicone rubber, platinum, iridium, or polyurethane
- •Allergy to local anesthetic or adhesives
- •Deemed unsuitable for enrollment by the investigator based on history or physical examination (e.g., bleeding disorders, current anticoagulant medications)
- •Enrolled in another investigational or interventional device or drug trial over the study period
研究组 & 干预措施
INTIBIA Therapeutic
Implanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study.
干预措施: INTIBIA Therapeutic (Device)
INTIBIA Non-Therapeutic
Implanted with INTIBIA device and programmed to non-therapeutic stimulation for the first 3 months, then to therapeutic stimulation for the duration of the study.
干预措施: INTIBIA Non-Therapeutic (Device)
结局指标
主要结局
Response Rate
时间窗: 12 Months
≥50% reduction in UUUI episodes in the INTIBIA therapeutic group
Response Rate
时间窗: 3 Months
≥50% reduction in UUI episodes between INTIBIA therapeutic and INTIBIA non-therapeutic
次要结局
- Daily Voids(3 Months)
- Urgency Score(3 Months)