Safety and Performance of UCon Patch Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - A Pivotal Clinical Investigation
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Urinary Incontinence
- 发起方
- InnoCon Medical
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Incidence of serious adverse device effects (SADEs).
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g., suppressing undesired bladder/bowel activity to relieve the symptoms of the patient.
This pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.
详细描述
The overall purpose of this pivotal clinical investigation is to evaluate the UCon device with a Patch Electrode with respect to clinical safety and device performance in a cohort of 180 patients with OAB/BD over a period of 12 weeks. The participants participate in a 12-week intervention period. For weeks 1-6, participants will be randomized (2:1 randomization) to either a treatment group using UCon-Patch with Time Limited stimulation or a sham group using UCon-Sham with sham stimulation. Participants in the treatment group will receive the actual stimulation with the intent of improving their symptoms, whereas those in the sham group will receive sham stimulation for short periods of time believed not to be capable of improving their symptoms. For weeks 7-12 of the intervention periods, the treatment group has the opportunity to add Urge stimulation to the Time Limited stimulation, while the sham group shifts to using UCon-Patch Time Limited stimulation. To assess the safety and performance of the UCon device on equal terms with similar devices in the market, the full intervention period with UCon will be conducted over 12 weeks, evaluating safety aspects of UCon on longer terms and confirming continued effects after 6 weeks in the treatment group. Additional analyses on data related to primary and secondary endpoints with safety and performance data from the 12-week follow-up will also be performed, but the primary analysis will focus on baseline and 6-week follow-up data.
研究者
入排标准
入选标准
- •Participant is ≥ 18 years of age.
- •Participant is diagnosed with OAB or BD.
- •Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.
排除标准
- •Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN.
- •Participant has an active infection in the genital area, including skin infections.
- •Participant has injured or irritated skin in the genital area, where the electrode is placed.
- •Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation).
- •Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function).
- •Participant is pregnant, nursing, planning a pregnancy (to be confirmed with a negative pregnancy test) or has given birth within the previous 12 months. Women of childbearing potential must maintain effective contraception\* during the clinical investigation.
- •Participant is enrolled or planning to enroll in another conflicting clinical investigation or was enrolled in an investigational drug trial within the previous 12 weeks or medical device investigation within 12 weeks of enrolment.
- •Participant has previously participated in a clinical investigation with UCon.
- •Participant has failed (lack of effectiveness) other neuromodulation treatments, e.g. sacral neuromodulation (SNM) within the previous 2 years.
- •Participant has a neurological disease, e.g., chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, stroke, central nervous system (CNS) tumors, Parkinson´s, spinal cord injury, diabetic neuropathy, Guillain-Barré syndrome.
结局指标
主要结局
Incidence of serious adverse device effects (SADEs).
时间窗: At 12 weeks.
Number of SADEs.
Ratio of treatment change [performance] of OAB symptoms.
时间窗: Change from baseline at 6 weeks.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Urinary Urgency (UU) voids (with or without Urgency Urinary Incontinence, UUI).
Ratio of treatment change [performance] of BD symptoms.
时间窗: Change from baseline at 6 weeks.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Faecal Urgency (FU) episodes OR at least a 50% reduction in Faecal Incontinence (FI) episodes.
次要结局
- Incidence and severity of adverse events (AEs).(At 12 weeks.)
- Ratio of treatment change [performance] of Urgency Urinary Incontinence.(Change from baseline at 6 weeks.)
- Self-reported quality of life measures as assessed by the International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol) questionnaire.(Change from baseline at 6 weeks.)
- Faecal Urgency (FU) episodes.(Change from baseline at 6 weeks.)
- Faecal Incontinence (FI) episodes.(Change from baseline at 6 weeks.)
- Self-reported quality of life measures as assessed by the Rockwood Fecal Incontinence Quality of Life Scale (FIQL) questionnaire.(Change from baseline at 6 weeks.)