Evaluation of a new catheter technology for urinary retention
Assessment of CymActive™ Catheter Technology for UrinAry ReTention and AcceptancE (The ACCTUATE Study)
This study is testing a new catheter designed for men who need long-term catheter use to see if it can improve their comfort and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Ingenion Medical Limited Industry-sponsored |
| Locations | 5 sites (Cambridge, Cambridgeshire and 4 other locations) |
| Trial ID | NCT05848037 on ClinicalTrials.gov |
What this trial studies
The ACCTUATE study assesses the CymActive™ catheter technology designed specifically for male long-term catheter users experiencing urinary retention. This interventional study aims to evaluate the tolerability of the new catheter by measuring patient-reported quality of life and pain levels over a 90-day period. Secondary endpoints include analyzing adverse events and conducting genomic profiling of urine samples to assess microbial diversity. The study addresses the urgent need for improved catheter designs to reduce complications associated with traditional catheters.
Who should consider this trial
Good fit: Ideal candidates for this study are adult males over 18 years old who have documented urinary retention and have been using a catheter for more than four weeks.
Not a fit: Patients with neurogenic urinary retention or those who have undergone certain surgical procedures in the lower urinary tract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for male patients with urinary retention by providing a more effective catheter solution.
How similar studies have performed: While traditional catheter designs have been widely used, this novel approach with the CymActive™ catheter is relatively untested, making it a potentially groundbreaking advancement.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cambridge, Cambridgeshire and 4 other locations
- Addenbrookes Hospital - Cambridge University Hospitals NHS Foundation Trust — Cambridge, Cambridgeshire, United Kingdom (Not_yet_recruiting)
- Royal Devon & Exeter Hospital - Royal Devon University Healthcare NHS Trust — Exeter, Devon, United Kingdom (Recruiting)
- Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust — Ipswich, Essex, United Kingdom (Not_yet_recruiting)
- Frimley Park Hospital - Frimley Health NHS Foundation Trust — Camberley, Surrey, United Kingdom (Recruiting)
- Southmead Hospital - North Bristol NHS Trust, — Bristol, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Hashim Hashim, MBBS, FEBU, FRCS — North Bristol NHS Trust
- Study coordinator: Elaine Brush, BSc.
- Email: elaine@ebclinical.co.uk
- Phone: +44(0)7775804423/(0)1237451407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.