Post-market Prospective Clinical Investigation on the Symptomatic Treatment of Urge Incontinence in Adults With Overactive Bladder With Cefar URO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
A Post-Market Prospective Clinical Investigation to collect PMCF data on the safety and performance of the Cefar URO device when using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the symptomatic treatment of urge incontinence in adults with overactive bladder in accordance with the approved labelling.
The Cefar URO device features four pre-set programs (P1, P2, P3 and P4) and three custom programs. Although supporting data on the preset programs P1, P2, P3 are available for the clinically equivalent UROstim2 device, program P4 is unique to Cefar URO. Program P4 utilizes the parameters 20Hz and 200μs which are commonly reported in the literature for the stated indications but for which no data is available for the clinically equivalent UROstim2 device. The present study is therefore aimed to cover this data gap.
详细描述
The objectives of this prospective study are to assess the performance and safety of Cefar URO when used at home by enrolled patients using the P4 program pre-set parameters i.e. frequency 20Hz, pulse width 200μs, for 12 weeks.
Adult patients who require symptomatic treatment of urge incontinence and associated symptoms with overactive bladder (including refractory overactive bladder of idiopathic or neurogenic origin), will undergo Transcutaneous Posterior Tibial Nerve Stimulation with the Cefar URO device at home.
The diagnosis of OAB is made by the Investigator on the basis of clinical symptoms in routine practice.
The assessment of symptoms and quality of life of patients will be completed before treatment (Baseline) and after 6 and 12 weeks of treatment with the Cefar URO device. An additional assessment of the maintenance of symptoms and quality of life will be performed 4 weeks after end of the per protocol treatment.
The tests used to assess symptoms and quality of life are and compliance with treatment are:
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
- •Adult patients with overactive bladder (including refractory overactive bladder of idiopathic or neurogenic origin) who require symptomatic treatment of urge incontinence and associated symptoms.
- •Subjects, both male and female, ≥ 18 years of age at the time of consent
- •Subjects have provided their written consent to participate in the study by signing the Ethics-approved consent form.
- •Patients are considered able and willing to self-administer transcutaneous tibial nerve stimulator (TTNS) treatment at home, based on Investigator's judgement.
- •Patients are suitable to receive treatment using the Cefar URO device P4 program pre-set parameters (frequency 20Hz and pulse width 200μs) for 12 weeks, based on Investigator's judgement.
- •If undergoing pharmacological therapy for incontinence, the therapy must be stabilized for at least 4 weeks before baseline visit
排除标准
- •Pregnancy confirmed by urine test at screening
- •Urinary tract infection confirmed by urine analysis
- •Serious secondary illness (such as renal failure, nephrolithiasis, bladder and kidney tumors)
- •Detrusor-sphincter dyssynergia
- •Patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD; or other implantable electronic devices
- •Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers
- •Subjects who are not able to read and understand indications and contraindications of the device
- •Subjects who are not able to sense auditory and visual signals
- •Patients with anti-incontinence surgery planned during the course of the study
- •Participation in another clinical study within 30 days prior to screening
研究组 & 干预措施
Transcutaneous Tibial Nerve Stimulator (TTNS) with the Cefar Uro Device
Patients will undergo Transcutaneous Posterior Tibial Nerve Stimulation with the Cefar URO device. The following parameters setting (preset program P4) will be used for treatment of all enrolled subjects:
- frequency of 20Hz
- pulse width of 200 μs
- duration: 30 minutes per treatment.
- treatment frequency: subjects will be recommended to have 7 treatment sessions per week for a total of 12 weeks (84 treatments total), and anyway no less that one treatment per week.
The electrodes will be placed in the medial ankle as according to the device IFU.
干预措施: Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device (Device)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From enrollment to the end of Treatment at 16 weeks.
\- adverse events/malfunctions/complications reported during the study. Subjects and Investigators will be prompted to record such issues on the AE evaluation form.
Frequency of Overactive Bladder Symptoms
时间窗: From enrollment to the end of Treatment at 12 weeks.
\- change in symptoms, at 12 weeks, quantified as the mean change from baseline on the Overactive Bladder-questionnaire-Short Form (OAB-q-SF), Symptoms bother scale (6 items) based on patient self-reporting. The lowest score for symptoms is 6, and the highest is 36. Higher score values are indicative of grater symptom bother and lower scores indicate minimal symptom bother. As per the literature (Zonic-Imamovic et al.,2021), we may expect an approximate mean reduction of the Symptoms Bother scale of 10.4 points at 12 weeks compared to the baseline measurement.
次要结局
- Number of Urinary Urgency and Urinary Frequency Episodes(From enrollment to the end of Treatment at 12 weeks.)
- Change in Quality of Life(From enrollment to the end of Treatment at 12 weeks.)