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

NCT05848037 | Terminated

• 1 other identifier: MF2208-A-R0001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Urinary Retention

Keywords

Urinary retention; Catheter; urology; urinary catheter; Quality of Life; TURP; Trans Urethral Resection of the Prostate; Randomised Controlled Study; RCT; CAUTI; Catheter Associated Urinary Tract Infection; novel; new; magnet; valve; patient

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

cymactive™ catheter device (CCD) arm

EXPERIMENTAL

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

Device: cymactive™ catheter device (CCD)

Foley-type device (FTD) arm

ACTIVE COMPARATOR

Approximately 60 participants will be recruited to this study. Approximately 30 patients in the FTD treatment group.

Device: Foley-type catheter device

Interventions

cymactive™ catheter device (CCD) DEVICE

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.

cymactive™ catheter device (CCD) arm

Foley-type catheter device DEVICE

Routine standard of care. Usually replaced \~ 3 monthly

Foley-type device (FTD) arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The device is designed for use in individuals who have a urethral length of between 11 - 16cm. As such, the device is not able to treat women or other people with a urethral length that is less than 11cm. The study will only recruit anatomically male subjects.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ingenion Medical Limited: lead

Study Sites (5)

Addenbrookes Hospital - Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Royal Devon & Exeter Hospital - Royal Devon University Healthcare NHS Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust

Ipswich, Essex, IP4 5PD, United Kingdom

Location

Frimley Park Hospital - Frimley Health NHS Foundation Trust

Camberley, Surrey, GU16 7UJ, United Kingdom

Location

Southmead Hospital - North Bristol NHS Trust,

Bristol, BS10 5NB, United Kingdom

Location

Related Links

• Ingenion Medical Ltd Homepage
• Urology News Article

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hashim Hashim, MBBS, FEBU, FRCS

  North Bristol NHS Trust

  PRINCIPAL INVESTIGATOR

• Edward C Cappabianca, BA, MBA

  Ingenion Medical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two treatment arms with patients randomised 1:1, into treatment arm (cymactive™ catheter) and routine standard of care arm (Foley-type catheter).

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 8, 2023
• Study Start: May 29, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)