Safety and Performance of UCon for the Treatment of the Symptoms of Faecal Incontinence (FI) - An Early Feasibility Study
概览
- 阶段
- 不适用
- 干预措施
- UCon
- 疾病 / 适应症
- Faecal Incontinence
- 发起方
- InnoCon Medical
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of the symptoms of FI in a home setting.
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). It electrically stimulates the 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. This clinical investigation is designed as a single-arm, prospective, single-centre, early feasibility study.
详细描述
The overall purpose of the current clinical investigation is to evaluate the medical device (UCon) with respect to initial safety and device performance in a cohort of Spanish patients with FI over a treatment period of 4 weeks.
研究者
入排标准
入选标准
- •Participant is ≥ 18 years of age.
- •Participant is showing symptoms of FI.
- •Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.
排除标准
- •Participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation).
- •Participant has an active infection in the genital area.
- •Participant 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).
- •Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception\* during the interventional period judged by the investigator.
- •Participant is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks to enrolment.
- •Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation, e.g., denervated patients and severe diabetic neuropathy.
- •Participant is currently receiving cancer treatment.
- •Participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
- •Participant does not speak and understand Spanish.
- •The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.
研究组 & 干预措施
Interventional arm
Electrical stimulation to the dorsal genital nerve.
干预措施: UCon
结局指标
主要结局
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of the symptoms of FI in a home setting.
时间窗: After 28 days (4 weeks)
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 FI symptoms in a home setting.
时间窗: Change from baseline at 28 days (4 weeks) and 42 days (6 weeks)
Ratio of subjects with at least 50% improvement of their FI symptoms from baseline. Participants shall complete an electronic bowel diary to report their symptoms
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 28 days (4 weeks))
- SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.(Change from baseline at 28 days (4 weeks) and 56 days (8 weeks, end of study))
- SECONDARY PERFORMANCE: To evaluate the ratio of subject that accept UCon and DGN stimulation [Device and treatment acceptability of UCon].(After 28 days (4 weeks))