Assessment of CymActive™ Catheter Technology for UrinAry ReTention and AcceptancE (The ACCTUATE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- To evaluate tolerability of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by patient-reported Quality of Life questionnaire.
研究概览
简要总结
The ACCTUATE study: Assessment of CymActive™ Catheter Technology for UrinAry reTention and acceptancE study will evaluate a novel catheter design that addresses the specific needs of male long term catheter users living in the community. The primary endpoint of the study will be tolerability, assessed by measuring patient-reported Quality of Life and VAS pain scale assessments up to approximately day 90 (end of study). The secondary endpoints will be comparisons of the Adverse Event nature and frequency, up to approximately 90 days (end of study) and genomic profiling of the abundance and diversity of microorganisms present in the screening visit urine sample versus the end of study urine sample of participants from both arms of the trial.
详细描述
There is an urgent need to address sub-optimal catheterisation that some men experience when living in the community with urinary retention problems. The catheters currently used within the NHS and in community settings are typically of the Intermittent or 'Foley' type. Foley type catheters are based on a nearly 100-year-old design, where an inflatable balloon, filled with water which anchors one end of the catheter within the bladder. At the other end, external to the body, a bag collects the urine, or a valve allows its discharge. Another option for patients requiring catheters is intermittent self-catheterisation. Intermittent catheters are single use, and self-catheterisation is needed multiple times per day, in order to empty the bladder. The number of times an intermittent catheter is used depends on the patient's condition and the frequency is guided by a Health Care Professional.
It is accepted that catheters in their current form, create a burden on the NHS, as Catheter Associated Urinary Tract Infections (CAUTI's) are one of the leading causes of healthcare-associated infections (HCAIs) and contribute significantly to mortality rates. Of Foley-type and intermittent users, the Foley- type catheters tend to lead to more infections.
The cymactive™ catheter (manufactured by Ingenion Medical Ltd) received CE marking on the 28th March 2024, as a Class IIb device (n. ECM24MDR002 rev.0, Single Registration Number (SRN) of the Manufacturer UK-MF-000041065). The cymactive™ catheter is designed to remain in situ for up to 30 days and does not extend outside the patient's body, except for two removal strings. The catheter has an integral, magnetically controlled valve that allows the user to control their own urination.
Study participants will be supplied with a magnetic Actuator (a separate Class I device supplied by Ingenion Medical), so they are in control of the valve and their own voiding.
The manufacturers of the cymactive™ catheter anticipate that the device may result in a better patient experience and potentially, a reduced risk of CAUTI when compared to a Foley catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participants will be eligible to enrol in the study only if all of the following apply
- •Male (anatomical)
- •Adult, more than or equal to 18 years of age
- •Capacity to give written informed consent
- •Documented urinary retention, this may include patients who await a TURP, or similar, procedure
- •Non-neurogenic urinary retention
- •Catheter use on a long-term basis (>4 weeks)
排除标准
- •Participants will not be eligible to enrol in the study if any of the following apply
- •Symptomatic bacteriuria (at screening)
- •Surgical procedures performed in the lower urinary tract
- •Neurogenic urinary retention
- •Patients who have had a TURP (or similar) procedure
- •Any malignancy in active/radical treatment (note: subjects with prostate or bladder cancer under surveillance only, may be enrolled into the study, at the Investigator's discretion)
- •Patients who have a pacemaker or significant cardiovascular disease
- •Participants with any contraindications, as outlined in the IFU
- •Active participation in another interventional trial within the last 30 days
- •Any condition, abnormality or issue, for which the investigator assesses the subject as unsuitable for an interventional study
结局指标
主要结局
To evaluate tolerability of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by patient-reported Quality of Life questionnaire.
时间窗: Up to approximately 90 days
Tolerability will be assessed using the validated Quality of Life questionnaire (ICIQ-LTCqol). The intervention cymactive™ catheter arm will be compared against the control, Foley type device, treatment arm.
1. To evaluate tolerability of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by patient-reported VAS pain scale.
时间窗: Up to approximately 90 days
Tolerability will be assessed using VAS pain scale assessments. The intervention cymactive™ catheter arm will be compared against the control, Foley type device, treatment arm.
次要结局
- Comparison of the genomic profile (abundance and diversity) of microorganisms present in the screening visit urine sample versus the end of study urine sample of participants from both arms of the trial.(Up to approximately 90 days)
- 1. To evaluate the safety of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by the nature and frequency of adverse events up to approximately day 90.(Up to approximately 90 days)