Assessment of CymActive™ Catheter Technology for UrinAry ReTention and AcceptancE (The ACCTUATE Study)

Study Overview
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Brief Summary
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The ACCTUATE: Assessment of CymActive™ Catheter Technology for UrinAry reTention and acceptancE study will begin the formal evaluation of a novel catheter design that addresses the specific needs of people living in the community with long term catheterisation. The primary endpoint of the study will be tolerability by measuring AEs, SAEs, AESIs through day 91. VAS scale assessments (1-10) across insertions and interventions by clinicians. The secondary endpoint will be a comparison in the number of re-presentations of patients requiring treatment in primary or secondary care for recurrent CAUTIs in both arms of the study along with comparing both arms to their medical history through routine standard of care.

Detailed Description
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There is an urgent need to address sub optimal catheterisation that men experience when living in the community with urinary retention problems. The catheters currently used within the NHS in the community settings are typically of the Intermittent or 'Foley' type. Foley types are based on a nearly 100-year-old design. An inflatable balloon, filled with water anchors one end within the bladder. At the other end, external to the body, a bag collects the urine, or a valve allows its discharge. Intermittent catheters are instead inserted multiple times daily in order to empty the bladder, before being removed. The amount of times an intermittent is swapped out for a new one depends on the patient's condition and the frequency is guided by a Health Care Professional. This study will compare the cymactive™ catheter and foley type catheters. This study has been designed as a pMDCS and is therefore the second phase of medical device assessment, with the CCD 1st generation device being CE Marked under the MDD. Based upon this and other existing devices, such as indwelling catheters, and prostatic stents, we are confident that the device is safe. ACCTUATE is a single-centre study for the assessment of the cymactive™ catheter device (referred to as CCD) both in terms of reduction of individuals' historic CAUTIs incidence associated with implementation, and in terms of tolerance and acceptability of patients and clinicians. The CCD will be administered as a replacement for a Foley-type device (referred to as FTD)and will be implemented for 30 days prior to removal and replacement with another CCD. This process will be repeated in 3, 30-day cycles. The study will consist of two arms: the CCD arm and the FTD arm. Patients will be recruited equally to each arm of the study. All participants will receive background local standard of care therapy according to participating institutions/hospitals regardless of the study group to which they belong. 60 participants will be recruited to this study. 30 patients in the CCD arm and 30 patients in the FTD. The study will begin with the recruitment of a Sentinel group of 20 patients consisting of 10 patients randomised to the CCD arm and 10 patients randomised to the FTD arm. Following this, a 4-week recruitment pause will take place in order to undertake an interim data capture of the Sentinel group data. The Sentinel group will continue to participate in the study during this time as detailed in the Schedule of Activities. This will give an opportunity to analyse any AEs/SAEs and patient data from the Sentinel group. Following this, the Study Physician, Coordinating Investigator and Sponsor will agree a date for the recommencement of recruitment to the study. Participants will be outpatient male adults (≥ 18 years) with a documented history of urinary retention based on a postvoidal residue scan, cystoscopy, urodynamic test or alternative diagnostic means; and catheter use and bladder-capacity issues on a long-term basis (>4 weeks).

Official Title
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Assessment of CymActive™ Catheter Technology for UrinAry ReTention and AcceptancE (The ACCTUATE Study)

Conditions
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Urinary Retention

Intervention / Treatment
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* Device: cymactiv catheter device
* Device: Foley-type catheter device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be eligible to enrol in the study only if all of the following apply: Male more than or equal to 18 years of age signed informed consent Experiencing documented urinary retention Patients who have not undergone TURP procedure but can be on waiting list for TURP procedure. Non-neurogenic urinary retention catheter use on a long-term basis (>4 weeks) Exclusion Criteria: • Symptomatic bacteriuria surgical procedures performed in the lower urinary tract Neurogenic urinary retention Patients who have had a TURP procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms with patients randomised into treatment arm (cymactive device) and routine standard of care arm (foley-type device).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cymactive catheter device arm<br>All participants will receive background local standard of care therapy according to participating institutions/hospitals regardless of the study group to which they belong. 60 participants will be recruited to this study. 30 patients in the CCD arm and 30 patients in the FTD. | Device: cymactiv catheter device<br>* A new type of catheter has recently been submitted for CE marking as a Class IIb device and will soon be available in the UK market. Ingenion Medical's cymactive™ Catheter is designed to remain in situ for up to 30 days, does not extend outside the patient's body and has an integral, magnetically controlled valve that allows the user to control their own urination. The patient will be supplied with their own magnet so they are in control of valve and their own voiding. The magnet is strong and care will need to be taken to keep it at least 6 inches from magnetically-sensitive items.<br>|
| Active Comparator: Foley-type device arm<br>All participants will receive background local standard of care therapy according to participating institutions/hospitals regardless of the study group to which they belong. 60 participants will be recruited to this study. 30 patients in the CCD arm and 30 patients in the FTD. | Device: Foley-type catheter device<br>* Routine standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate tolerability of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by the VAS scale. | Endpoint: VAS scale assessments (1-10) across insertions and interventions by clinicians. | 91 days | 
| To evaluate tolerability of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by occurrence of adverse events through day 91. | AEs, SAEs, AESIs through day 91. | 91 days | 
| Patient tolerance of the cymactive™ catheter device compared to Foley-type devices as assessed by QoL questionnaire. | Standard QoL questionnaire at each interaction with an HCP to 91 days. | 91 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare both arms and each patient's historical requirement for clinician assessment in primary or secondary care for UTI and any other reasons. | A composite of either tolerance across each 30-day insertion period for the CCD and patient acceptability scores determined by diary recording versus tolerance and patient acceptability for standard of care for the FTD. Intercurrent events: The set of intercurrent events for this estimand consists of the clinical intervention to substitute or remove the CCD prior to day 30 of each of the intended 3 insertions over the 3 months of the patient's participation in the trial without having met the primary endpoints. | 91 days |