This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.

This investigation was a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.

Inclusion Criteria:

1. Has given written informed consent
2. Is at least 18 years and have full legal capacity
3. Is female
4. Has a negative urine Multistix dipstick test for erythrocytes (haematuria)

Exclusion Criteria:

1. Has used an internal urinary catheter or cystoscopy within the past month
2. Has prior history of bladder surgery
3. Is symptomatic and/or on medication for overactive bladder
4. Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
5. Is pregnant and/or breast-feeding
6. Is participating in other clinical investigations during this investigation
7. Is menstruating during study period

This device is a female catheter.

Female healthy volunteers with an average age of 40 (range: 18-71 years) and no prior prophylactic antibiotic.

The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.