NCT04758247已完成不适用
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The primary effectiveness endpoint is the percentage of subjects with at least a 50% reduction in frequency of UUI events from baseline to 12 weeks as measured in 3-day voiding diaries.
研究概览
简要总结
To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.
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
- •Women and men ≥18 years of age
- •Individual has a diagnosis of OAB with urge urinary incontinence or mixed incontinence (urge and stress) with urge urinary incontinence being the most bothersome type of urinary incontinence for at least 6 months (self-reported)
- •Individual has ≥4 incontinence events with associated moderate or severe urgency (UUI events), with at least one UUI event per day, as recorded in the baseline 3-day voiding diary
- •Individual has a mean frequency of urinary voiding events per day ≥10 times in one 24-hour day as recorded in the baseline 3-day voiding diary
- •Individual is ambulatory and able to use the toilet independently
- •Individual has not taken antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment
- •Individual is able to provide informed consent
- •Individual is capable and willing to follow all study-related procedures
排除标准
- •• Individual has stress urinary incontinence as the most bothersome type of urinary incontinence (self-report)
- •Individual has an abnormal post-void residual urine volume (>150 cc at baseline)
- •Male who has a clinically significant bladder outlet obstruction (assessed by uroflow, maximum flow rate <15 mL/s for a voided volume of at least 150 cc)
- •Male who has been previously diagnosed with Benign Prostate Hyperplasia
- •Male who has abnormal serum PSA (>2.5 ng/mL)
- •Individual has abnormal serum creatinine levels (>1.2 mg/dL for women and >1.4 mg/dL for men)
- •Individual has history of chronic kidney disease
- •Female of childbearing age (≤50 years old) who is pregnant as confirmed by urine pregnancy test, or who plans to become pregnant during the study period
- •Female who is less than one-year post-partum and/or is breast-feeding
- •Female with a clinically significant pelvic organ prolapse (≥ stage III on POP-Q evaluation)
- •Individual has diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C ≥ 8.5)
- •Individual has known polyuria
- •Individual has an active urinary tract infection (UTI) at the time of enrollment
- •Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months
- •Individual has peripheral arterial disease
- •Individual has the presence of a urinary fistula, bladder stone, or interstitial cystitis
- •Individual has a diagnosis of prostate, urethral, or bladder cancer
- •Individual has morbid obesity (BMI ≥ 40)
- •Individual has clinically significant urethral stricture disease or bladder neck contracture
- •Individual has a metallic implant that is exposed above the bone surface (e.g. a bone fracture fixation plate, but not an embedded bone screw) and is located under the skin on the bottom of the foot for either or under the skin on the anterior aspect of the mid-thigh for either leg.
- •Individual has an implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
- •Individual has had previous treatment with sacral neuromodulation
- •Individual has been treated with percutaneous tibial nerve stimulation or pelvic floor muscle stimulation
- •Individual is currently using, or has used in the past 3 months, transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, legs, or feet
- •Individual has been treated with onabotulinumtoxinA in the past 9 months
- •Individual has a clinically significant peripheral neuropathy
- •Individual has a history of pelvic pain as primary diagnosis in the past 12 months (VAS score of >4 (scale of 0 to 10))
- •Individual has neurogenic bladder (i.e. Multiple Sclerosis, Parkinson's, Spinal Cord Injury)
- •Individual has used an investigational drug, biologic, or medical device in the past 4 weeks
- •Individual is deemed unsuitable for enrollment in the study by the investigator based on the subject's history or physical examination
研究组 & 干预措施
Active
Active Comparator
干预措施: TheraNova Neuromodulation System (Device)
Sham
Sham Comparator
干预措施: TheraNova Neuromodulation System (Device)
结局指标
主要结局
The primary effectiveness endpoint is the percentage of subjects with at least a 50% reduction in frequency of UUI events from baseline to 12 weeks as measured in 3-day voiding diaries.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder SymptomsOveractive BladderNCT05162833Theranova, L.L.C.3
招募中
不适用
Bilateral Nucleus Accumbens Focused Ultrasound Neuromodulation for Stimulant Use DisorderPsychostimulant Use Disorder(PUD)NCT06474026Korea University Anam Hospital15
已完成
不适用
Deep Brain Stimulation (DBS) for the Suppression of TremorTremorAction TremorTremor, LimbEssential TremorNCT02087046Abbott Medical Devices127
招募中
不适用
Sacral Neuromodulation for Male Overactive Bladder (MOAB)Urinary Urgency IncontinenceOveractive BladderBenign Prostatic HyperplasiaProstate CancerOveractive BladderBenign Prostatic HyperplasiaProstate CancerUrinary Urgency IncontinenceProstatectomyUrinary FrequencyNCT06511141Axonics, Inc.150
Unknown
不适用
Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy SubjectsConstipationNCT06294457Universidad Europea de Madrid40