NCT05226286已完成不适用
Evaluation of Implantable Tibial Neuromodulation Pivotal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 58
- 主要终点
- UUI Responder
研究概览
简要总结
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years of age or older
- •Qualifying voiding diary
- •Have a diagnosis of UUI for at least 6 months
- •Failed and/or are not a candidate for conservative therapies.
- •Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
排除标准
- •Have primary stress incontinence
- •History of a prior implantable tibial neuromodulation system
- •Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
- •Previous pelvic floor surgery in the last 6 months
- •Women who are pregnant or planning to become pregnant during the course of the study
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
结局指标
主要结局
UUI Responder
时间窗: 6 months
Proportion of TNM subjects experiencing a reduction of 50% or more in daily urinary urge incontinence (UUI) episodes (UUI responder rate) at 6 months after device implant.
次要结局
- UUI Change From Baseline(6 months)
- UF Change From Baseline(6 months)
- UPS Change at 6 Months(6 months)
- OAB-q Change From Baseline(6 months)
研究者
研究点 (58)
Loading locations...
相似试验
已完成
不适用
Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility StudyOveractive BladderNCT04873271MedtronicNeuro24
招募中
不适用
Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.Lower Urinary Tract SymptomsMultiple SclerosisNCT04573673University Hospital, Lille68
终止
1 期
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal IncontinenceFecal IncontinenceNCT01666405Uroplasty, Inc30
已完成
不适用
Efficiency of Neurostimulation of Tibial Nerve in the Treatment of Low Anterior Resection SyndromeColorectal SurgeryNCT02517853Hospital Universitari Vall d'Hebron Research Institute41
已完成
不适用
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)Overactive BladderNCT04115228Nine Continents Medical, Inc.10