NCT03874780已完成不适用
First in Human (FIH) Study for the Evaluation of the Safety and Early Performance of the Vibe Delivery System for the Delivery of Botox™ in Subjects With Idiopathic Overactive Bladder (OAB)
Vensica Therapeutics Ltd.2 个研究点 分布在 2 个国家目标入组 10 人开始时间: 2019年1月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Serious Adverse Events Reporting
研究概览
简要总结
This First In Human study is aimed to evaluate the safety and initial efficacy of the Vibe delivery system in delivering Botox (TM) to the bladder wall in patients diagnosed with overactive bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects between the ages of 18 to 80 years old diagnosed with idiopathic OAB.
- •Subject has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.
- •Subjects with symptoms of incontinence associated with OAB for ≥ 3 months prior to screening.
- •Subjects who are non-responsive, non-compliant or intolerable to pharmacologic oral therapy (e.g., anticholinergic agents).
- •Subject is willing and able to initiate self-catheterization post-treatment, if required.
- •Subjects with PVR ≤200 ml.
- •Subjects who are mentally competent, with the ability to understand and comply with the requirements of the study.
- •A negative urine pregnancy test during screening in women with childbearing potential. A female subject will also agree to use an adequate birth control method for the duration of her participation in the study and for a period of 6 months after participation completion.
排除标准
- •Subjects currently using Clean intermittent catheterization (CIC) or indwelling catheter to manage their urinary incontinence.
- •Pregnant or breastfeeding women, or women of childbearing potential who are planning to become pregnant during the study period or not practicing reliable contraception methods.
- •Subjects with clinically significant Bladder Outlet Obstruction (BOO) according to medical history.
- •Subjects with active urinary tract infection, as diagnosed on screening urinalysis.
- •Subjects with known polyuria or polydipsia.
- •Subjects with a known positive diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
- •Subjects with OAB due to any known neurological reason.
- •Subjects currently undergoing biofeedback, pelvic muscle rehabilitation, pelvic floor physical therapy, or electrical-stimulation who are unwilling to discontinue such treatments for the duration of study participation.
- •Subject with a 24-hour total urine volume voided greater than 3,000 ml, as measured at screening visit.
- •Predominance of stress incontinence in the opinion of the investigator, determined by medical history.
- •Subjects with vesico-ureteral reflux, genitourinary fistulae.
- •Subjects with pelvic organ prolapse stage III or IV, (i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen at straining).
- •Subjects with prior Botox™ therapy of any serotype within 12 weeks for any indication, including urologic condition.
- •Subjects with a history of pelvic radiation therapy.
- •Subject who is morbidly obese (BMI > 40 Kg/m2).
- •Subjects with a history of treatment for two or more UTIs within 6 months prior to screening or use of prophylactic antibiotics to prevent chronic UTIs.
- •Subjects on immunomodulatory therapy (suppressive or stimulatory).
- •History or evidence of any pelvic or lower tract genitourinary abnormalities, malignancy, bladder surgery (excluding stress incontinence or pelvic organ prolapse surgeries), or disease, other than OAB.
- •Subjects with operative sling erosion.
- •History of interstitial cystitis/painful bladder syndrome, in the opinion of the investigator.
- •Subjects with current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
- •Subject has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
- •Any other condition or medical history, that to the discretion of the investigator and/or Sponsor, excludes the subject from participation in the study.
结局指标
主要结局
Serious Adverse Events Reporting
时间窗: 7 days
Incidence of device related SAEs
次要结局
- Urgency(12 weeks)
- Incontinence(12 weeks)
- Nocturia(12 weeks)
- Serious Adverse Events Reporting(12 weeks)
- Micturition(12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI PatientsHigh-Risk Percutaneous Coronary InterventionNCT06099548Magenta Medical Ltd.20
招募中
1 期
A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid TumorAdvanced Solid TumorsRefractory LymphomaRelapsed Hematologic MalignancyNCT06615193Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.111
已完成
1 期
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and InfantsDiarrhoeaNCT05073003GlaxoSmithKline551
暂停
1 期
A Study of CS5001 in Patients With Advanced Solid Tumors and LymphomasAdvanced Solid TumorAdvanced LymphomaNCT05279300CStone Pharmaceuticals480
招募中
Unknown
TetraDERM for Scar ReductioScar ManagementSurgery - Other surgerySkin - Other skin conditionsACTRN12624000965505Tetratherix Technology Pty Ltd45