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

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Retention
• Intervention / Treatment: Device: cymactive™ catheter device (CCD); Device: Foley-type catheter device

Detailed Description

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.

ACCTUATE is a multi-centre study, comparing the cymactive™ catheter device (CCD) versus Foley-type devices (FTD) in men with non-neurogenic urinary retention.

Study participants will be randomised (1:1) to receive either the cymactive™ catheter or a Foley catheter (the control arm) and the relevant catheter will be inserted on day 1 of the study. The cymactive™ catheters will be replaced approximately every 30 days, with a total study duration of approximately 90 days. Study participants randomised to the Active Comparator arm will receive the standard of care catheter (Foley) on day 1, for approximately 90 days. At the end of study visit (approx. day 90), CCD-treated subjects will undergo the removal of the CCD and a return to standard of care treatment, typically a FTD. However, as the cymactive™ device is CE marked, there is the possibility that the device may be available for post-study use, dependent upon clinical opinion and cymactive™ availability at specific institutions.

Approximately 60 participants will be recruited to this study; 30 patients in the CCD arm and 30 patients in the FTD arm.

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. A review of the Sentinel group data, up to day 30 of the study, may be undertaken to examine any potential futility and/or safety signals. The Sentinel group will continue to participate in the study during this time as detailed in the Schedule of Activities.

Participants will be male adults (≥ 18 years) with a documented history of non-neurogenic urinary retention and long-term catheter use (> or = 4 weeks).

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital - North Bristol NHS Trust,
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Addenbrookes Hospital - Cambridge University Hospitals NHS Foundation Trust
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon & Exeter Hospital - Royal Devon University Healthcare NHS Trust
  • Essex
    • Ipswich, Essex, United Kingdom, IP4 5PD
      • Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust
  • Surrey
    • Camberley, Surrey, United Kingdom, GU16 7UJ
      • Frimley Park Hospital - Frimley Health NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cymactive™ catheter device (CCD) arm; Approximately 60 participants will be recruited to this study. Approximately 30 patients in the CCD arm.	Device: cymactive™ catheter device (CCD); 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) and will be available in the UK market, subject to local arrangements. The cymactive™ catheter is designed to remain in situ for up to 30 days, does not extend outside the patient's body except for 2 removal strings, and has an integral, magnetically controlled valve that allows the user to control their own urination. The study participant will each be supplied with a magnetic Actuator (a separate Class I device supplied by Ingenion Medical) 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, i.e. mobile phones, laptops and credit cards. Study participants should also avoid contact with MRI machines.
Active Comparator: Foley-type device (FTD) arm; Approximately 60 participants will be recruited to this study. Approximately 30 patients in the FTD treatment group.	Device: Foley-type catheter device; Routine standard of care. Usually replaced ~ 3 monthly

What is the study measuring?

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 patient-reported Quality of Life questionnaire.	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.	Up to approximately 90 days
1. To evaluate tolerability of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by patient-reported VAS pain scale.	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.	Up to approximately 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Genomic profiling of the diversity and abundance of microorganisms providing insight in the microbial populations in the screening and end of study urine samples will be compared for each subject and for each treatment arm in a descriptive way.	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.	All AEs including CAUTIs in both treatment arms will be collected up to approximately study day 90. The proportion of patients with one or more AEs at 90 days and the proportion of patients with one or more CAUTIs will be compared between the CCD and the FTD group using a binomial test.	Up to approximately 90 days

Collaborators and Investigators

• Sponsor: Ingenion Medical Limited
• Collaborators: Ingenion Medical Limited
• Investigators: Principal Investigator: Hashim Hashim, MBBS, FEBU, FRCS, North Bristol NHS Trust; Study Director: Edward C Cappabianca, BA, MBA, Ingenion Medical Ltd.

Publications and helpful links

Helpful Links

• Urology News Article
• Ingenion Medical Ltd Homepage

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; RCT; Urinary retention; valve; Catheter; patient; new; TURP; urology; urinary catheter; CAUTI; Randomised Controlled Study; novel; Catheter Associated Urinary Tract Infection; Trans Urethral Resection of the Prostate; magnet
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention
• Other Study ID Numbers: MF2208-A-R0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No