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

Launched by INGENION MEDICAL LIMITED · May 4, 2023

Keywords

ClinConnect Summary

The ACCTUATE Study is looking at a new type of catheter, called the CymActive™ catheter, designed specifically for men who need to use catheters for a long time due to urinary retention. Urinary retention means that a person has difficulty emptying their bladder fully, which can be uncomfortable and lead to other health issues. This study aims to see how well the new catheter works and how it affects the quality of life for users over about 90 days. Participants will share their experiences regarding any pain or discomfort, and researchers will also look at any side effects and changes in bacteria in their urine.

To be eligible for this study, participants must be men aged 18 or older who have been using a catheter for more than four weeks and have a documented issue with urinary retention. They should not have certain medical conditions, like infections in the urinary tract or specific types of cancer currently being treated. Those who join the study can expect to provide feedback on their experience and undergo urine tests at the beginning and end of the study to help researchers understand how the new catheter affects their health over time.

Gender

MALE

Eligibility criteria

• 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