N/A
Completed N=43
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter
Source: ClinicalTrials.gov NCT05224544 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale. — 0.84; 0.76 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale. |
0.84; 0.76 | — |
Eligibility Criteria
Inclusion Criteria
- Has given written informed consent
- Is at least 18 years and have full legal capacity
- Is female
- Has a negative urine Multistix dipstick test for erythrocytes (haematuria)
Exclusion Criteria
- Has used an internal urinary catheter or cystoscopy within the past month
- Has prior history of bladder surgery
- Is symptomatic and/or on medication for overactive bladder
- Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
- Is pregnant and/or breast-feeding
- Is participating in other clinical investigations during this investigation
- Is menstruating during study period
Data sourced from ClinicalTrials.gov (NCT05224544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.