TerminatedNot Applicable

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

Stopped: Slow study recruitment within the current protocol and the time required to implement an amended study protocol led the Sponsor decision to cease participant recruitment and to discontinue the study.

United Kingdom6 participantsStarted 2025-05-29

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To evaluate tolerability of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by patient-reported Quality of Life questionnaire.

Timeframe: 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.

Timeframe: Up to approximately 90 days

Trial details

NCT IDNCT05848037

SponsorIngenion Medical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-10

View on ClinicalTrials.gov More Urinary Retention trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To evaluate tolerability of the cymactive™ catheter device (CCD) compared to Foley-type devices (FTD) as assessed by patient-reported Quality of Life questionnaire.

Timeframe: 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.

Timeframe: Up to approximately 90 days