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

NCT05848037 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-01-15

No results posted yet for this study

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

Interventions

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.

DEVICE

Foley-type catheter device

Routine standard of care. Usually replaced \~ 3 monthly

Sponsors & Collaborators

  • Ingenion Medical Limited

    lead INDUSTRY

Principal Investigators

  • Hashim Hashim, MBBS, FEBU, FRCS · North Bristol NHS Trust

  • Edward C Cappabianca, BA, MBA · Ingenion Medical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2025-10-10
Completion
2025-10-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05848037 on ClinicalTrials.gov