Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD) - An Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
研究概览
简要总结
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number of subjects. UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel disorders (BD). It electrically stimulates the dorsal genital nerve (DGN) through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient.
详细描述
The study is conducted at multiple hospitals in Denmark (Aarhus University Hospital, Odense University Hospital and Herlev Hospital). It is estimated that 20 subjects with OAB and 20 subjects with BD will need to be enrolled at the investigational sites to account for screening attrition and dropouts. Screening and baseline measurements includes a 7-days bladder diary (OAB) / 14-days bowel diary (BD) and quality-of-life measures. Following the screening and baseline measurements, the subjects will be introduced and trained on how to set up and use UCon. For 1 month the subjects will use UCon at home and complete a daily bladder/bowel diary and a stimulation diary. After completion of the interventional period, subjects will fill out the quality-of-life measures once again.
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
- •Subject is ≥ 18 years of age.
- •Subject is diagnosed with OAB or BD.
- •Subject is able to communicate, provide feedback, understand and follow instructions during the course of the study.
- •Subject has signed an informed consent.
排除标准
- •Subject is medically unstable.
- •Subject has an active infection in the genital area.
- •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 pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test within 14 days prior to enrolment). Women of childbearing potential must maintain effective contraception* during the study period judged by the investigator.
- •Subject is enrolled or planning to enrol in another investigational study or was enrolled in an investigational drug or medical device trial 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 cannabis, opioids, or other intoxicating drugs.
- •Subject does not speak and understand Danish.
研究组 & 干预措施
Interventional arm
Electrical stimulation to the dorsal genital nerve.
干预措施: UCon (Device)
结局指标
主要结局
Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
时间窗: After 4 and 12 weeks of stimulation (end of study).
Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.
Ratio of subjects with at least 50% improvement of their OAB/BD symptoms from baseline associated with the use of UCon.
时间窗: Change from baseline OAB/BD symptoms at 4 and 12 weeks.
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. Faecal urgency is measured by number of urgency episodes/day. Frequent bowel movements are measured by number of voidings/day. Faecal incontinence (urge/passive) is measured by number of leaks/day.
次要结局
- Ratio of subjects with improvement in their OAB/BD specific quality-of-life measures from baseline.(Change from baseline QoL at 4 and 12 weeks.)
- Frequency and severity of all adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.(After 4 and 12 weeks of stimulation (end of study).)