Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting.
研究概览
简要总结
UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.
详细描述
The purpose of the current investigation is to obtain information about the type of stimulation that Ucon provide (time limited vs. urge stimulation), would be the most effective and feasible for the treatment of non-neurogenic OAB symptoms in males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age.
- •Subject is male.
- •Subject is diagnosed with OAB
- •Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
排除标准
- •Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
- •Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
- •Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
- •Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
- •Subject has used antimuscarinics or β3 agonists within 14 days weeks*.
- •Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).
- •Subject is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug study or medical device investigation within four weeks to enrolment.
- •Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
- •Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
- •Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
- •Subject does not speak and understand Dutch.
- •If a subject is currently being treated with antimuscarinics or β3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.
结局指标
主要结局
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting.
时间窗: After 44 days (end of study)
Characterization of adverse events and anticipated adverse device effects associated with the use of UCon during the investigational period.
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of OAB symptoms using UCon in a home setting
时间窗: Change from baseline at 14 days, 30 days and 44 days (study end)
Ratio of subjects with at least 50% change in their OAB symptoms from baseline. Participants shall complete a 3-day bladder diary to report their symptoms. The symptoms related to OAB: * Urinary urgency is measured by number of urgency episodes/day. * Urinary frequency is measured by number of voidings/day. * Urgency urinary incontinence is measured by number of leaks preceded by urgency/day. * Nocturia is measured by number of voidings/night.
次要结局
- SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.(After 44 days (end of study))
- SECONDARY PERFORMANCE: To evaluate the device and treatment acceptability of UCon.(After 44 days (study end))
- SECONDARY SAFETY: To evaluate the severity of adverse events associated with the use of UCon during the investigational period.(After 44 days (study end))
- SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.(Change from baseline at 14 days and 44 days (end of study))
- SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their treatment outcome (i.e. symptoms) after therapy.(Change from baseline at 14 days and 44 days (end of study))