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

Urinary Retention Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Urinary Retention

• NCT number: NCT05848037
• Study type: Interventional
• Source: Nottingham Trent University
• Contact: Elena Hunter, PhD
• Phone: 07898802790
• Email: elena.hunter@ntu.ac.uk
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Completion date: January 31, 2025