A new urinary catheter designed to improve bladder drainage Urological and Genital Diseases
Conditions
Interventions
The study is a non-randomised, prospective trial of the new Flume urinary catheter.
The aims and objectives of the study are to evaluate the safety, tolerability and ease of use of th
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage 1 1. Adults (>=18 years) of either gender, who are willing to participate in the study and give their written informed consent. 2. Subjects who are due to undergo planned general anaesthetic cystoscopy (routine endoscopic bladder inspection) – stage 1a only. 3. Subjects who are due to undergo a urological operation for which an indwelling catheter is routinely used – stage 1b only. Stage 2 1. Adults (>= 8 years) of either gender. 2. Patients who need an indwelling urinary catheter as a method of bladder drainage for at least one month. 3. Patients who are willing and able to participate in the study and give their written informed consent. 4. Established catheter users. (Defined as “had a Foley catheter for at least the last 6 months and anticipate continuing to use one for at least the next 3 months”).
Exclusion criteria
Exclusion criteria: Stage 1 1. Catheter-associated UTI at time of assessment, according to National Healthcare Safety Network (NHSN) surveillance and clinical criteria. One re-screen per subject is allowed, once the infection has been treated, the patient is eligible for the study. (https://www.cdc.gov/nhsn/index.html) 2. Participants who are on systemic antibiotics within 48 hours prior to enrolment. 3. Patient with a known allergy to any of the materials used in the FLUME catheter. 4. Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter. 5. Informed consent cannot be obtained (See Section 12 for assessment of capacity). 6. Patient is breast feeding or pregnant, confirmation that the women is not pregnant will be determined by [1] clear indication of menopause, [2] time since last menstruation or [3] confirmation of abstinence. Women of child-bearing age will be asked to perform a pregnancy test if applicable after obtaining their consent. 7. Patients who have undergone a TURP (Transurethral resection of the prostate) within the last 3 months. 8. Patients for whom a Fr14 sized dual lumen catheter would be inappropriate. Stage 2 1. Catheter-associated UTI at time of assessment, according to National Healthcare Safety Network (NHSN) surveillance and clinical criteria. One re-screen per subject is allowed, once the infection has been treated, the patient is eligible for study. This will be recorded through self reporting of symptoms and/or prescribed antibiotics. 2. Participants who are on systemic antibiotics within 48 hours prior to enrolment. 3. Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period. 4. Suprapubic catheter user. 5. Patient with a known allergy to polyurethane or silicone used in the FLUME or comparator catheter. 6. Patient has urinary tract anatomical abnormality that would prevent placement of a standard Foley catheter. 7. Informed consent cannot be obtained. 8. Patient is unable or unwilling to comply with the study follow-up schedule. 9. Patient is breastfeeding woman or pregnant (confirmation that the woman is not pregnant will be determined by [1] clear indication of menopause, [2] time since last menstruation or [3] confirmation of abstinence. Women of child-bearing age will be asked to perform a pregnancy test if applicable (after obtaining their consent). 10. New catheter users. 11. Patients for whom scheduled catheter changes are more frequent than monthly. 12. Cognitive impairment affecting ability to complete outcome assessments (in the opinion of the investigator). 13. Patients who have undergone a TURP (Transurethral resection of the prostate) within the last 3 months. 14. Patients for whom a Fr14 sized dual lumen catheter would not be appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Ratings of catheter function from HCP questionnaire: 1.1. Ease of Placement – to be measured via a questionnaire completed by the HCP right after the procedure 1.2. Bladder drainage - to be measured via a questionnaire completed by the HCP right after the procedure 1.3. Remained in situ – to be measured via a questionnaire completed by the HCP right after the procedure 1.4. Ease of removal – to be measured via a questionnaire completed by the HCP right after the procedure 2. Proportion of patients reporting an adverse event associated with their catheter – information is collected onto a CRF by a Research nurse 7 days after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To identify any problems with the FLUME design and manufacture, resulting from its use, particularly if impacting safety – measured by the type and incidence of adverse events throughout the duration of the trial 2. Incidence of Device Deficiency (DD) with Serious Adverse Device Effect (SADE) and DD with Adverse Device Effect (ADE) – information is collected onto a CRF by a Research nurse 7 days after the procedure 3. HCP experience and feedback – collected via a qualitative interview (Only applies to Stage 2) 4. Participant experience and feedback – collected via a qualitative interview and via the completion of questionnaires: PGI; VAS; EQ-5D-L and ICIQ-LCTqol (only applies to Stage 2) | — |
Countries
England, United Kingdom
Outcome results
None listed